{"id":8140,"date":"2019-04-03T22:59:36","date_gmt":"2019-04-03T15:59:36","guid":{"rendered":"https:\/\/pharmog.com\/wp\/?p=8140"},"modified":"2025-01-08T23:01:33","modified_gmt":"2025-01-08T16:01:33","slug":"metformin-saxagliptin-komboglyze-xr","status":"publish","type":"post","link":"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/","title":{"rendered":"Metformin + Saxagliptin &#8211; Komboglyze XR"},"content":{"rendered":"<h1><span class=\"ez-toc-section\" id=\"thong-tin-to-huong-dan-su-dung-cua-thuoc-komboglyze-xr\"><\/span>Th\u00f4ng tin t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c Komboglyze XR<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p><em>D\u01b0\u1edbi \u0111\u00e2y l\u00e0 n\u1ed9i dung t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a Thu\u1ed1c Komboglyze XR (Th\u00f4ng tin bao g\u1ed3m li\u1ec1u d\u00f9ng, c\u00e1ch d\u00f9ng, ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, th\u1eadn tr\u1ecdng, d\u01b0\u1ee3c l\u00fd&#8230;)<\/em><\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 ez-toc-wrap-left counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">N\u1ed9i dung ch\u00ednh<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#thong-tin-to-huong-dan-su-dung-cua-thuoc-komboglyze-xr\" >Th\u00f4ng tin t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c Komboglyze XR<\/a><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#1-ten-hoat-chat-va-biet-duoc\" >1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#2-dang-bao-che-%e2%80%93-ham-luong\" >2. D\u1ea1ng b\u00e0o ch\u1ebf &#8211; H\u00e0m l\u01b0\u1ee3ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#3-video-by-pharmog\" >3. Video by Pharmog:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#4-ung-dung-lam-sang\" >4. \u1ee8ng d\u1ee5ng l\u00e2m s\u00e0ng:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#41-chi-dinh\" >4.1. Ch\u1ec9 \u0111\u1ecbnh:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#42-lieu-dung-%e2%80%93-cach-dung\" >4.2. Li\u1ec1u d\u00f9ng &#8211; C\u00e1ch d\u00f9ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#43-chong-chi-dinh\" >4.3. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#44-than-trong\" >4.4 Th\u1eadn tr\u1ecdng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#45-su-dung-cho-phu-nu-co-thai-va-cho-con-bu\" >4.5 S\u1eed d\u1ee5ng cho ph\u1ee5 n\u1eef c\u00f3 thai v\u00e0 cho con b\u00fa:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#46-tac-dung-khong-mong-muon-adr\" >4.6 T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (ADR):<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#47-huong-dan-cach-xu-tri-adr\" >4.7 H\u01b0\u1edbng d\u1eabn c\u00e1ch x\u1eed tr\u00ed ADR:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#48-tuong-tac-voi-cac-thuoc-khac\" >4.8 T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#49-qua-lieu-va-xu-tri\" >4.9 Qu\u00e1 li\u1ec1u v\u00e0 x\u1eed tr\u00ed:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#5-co-che-tac-dung-cua-thuoc\" >5. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c :<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#51-duoc-luc-hoc\" >5.1. D\u01b0\u1ee3c l\u1ef1c h\u1ecdc:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#52-duoc-dong-hoc\" >5.2. D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#53-hieu-qua-lam-sang\" >5.3. Hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#54-du-lieu-tien-lam-sang\" >5.4. D\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#6-phan-thong-tin-kem-theo-cua-thuoc\" >6. Ph\u1ea7n th\u00f4ng tin k\u00e8m theo c\u1ee7a thu\u1ed1c:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#61-danh-muc-ta-duoc\" >6.1. Danh m\u1ee5c t\u00e1 d\u01b0\u1ee3c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#62-tuong-ky\" >6.2. T\u01b0\u01a1ng k\u1ef5 :<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#63-bao-quan\" >6.3. B\u1ea3o qu\u1ea3n:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#64-thong-tin-khac\" >6.4. Th\u00f4ng tin kh\u00e1c :<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#65-tai-lieu-tham-khao\" >6.5 T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin-komboglyze-xr\/#7-nguoi-dang-tai-tac-gia\" >7. Ng\u01b0\u1eddi \u0111\u0103ng t\u1ea3i \/T\u00e1c gi\u1ea3:<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h2><span class=\"ez-toc-section\" id=\"1-ten-hoat-chat-va-biet-duoc\"><\/span>1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong><em>Ho\u1ea1t ch\u1ea5t :<\/em> <a href=\"https:\/\/pharmog.com\/wp\/metformin-saxagliptin\/\">Metformin + Saxagliptin<\/a><\/strong><\/p>\n<p><strong><em>Ph\u00e2n lo\u1ea1i: <\/em><\/strong><em>Thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ti\u1ec3u \u0111\u01b0\u1eddng d\u1ea1ng k\u1ebft h\u1ee3p.<\/em><\/p>\n<p><strong><em>Nh\u00f3m<\/em><\/strong> <strong><em>ph\u00e1p l\u00fd: <\/em><\/strong><em>Thu\u1ed1c k\u00ea \u0111\u01a1n ETC \u2013 (Ethical drugs, prescription drugs, Prescription only medicine)<\/em><\/p>\n<p><strong><em>M\u00e3 ATC<\/em><\/strong> (Anatomical Therapeutic Chemical): A10BD10.<\/p>\n<p><strong><em>Bi\u1ec7t d\u01b0\u1ee3c g\u1ed1c:<\/em><\/strong> Komboglyze XR.<\/p>\n<p><strong><em>H\u00e3ng s\u1ea3n xu\u1ea5t <\/em><\/strong>: AstraZeneca Pharmaceuticals LP<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2-dang-bao-che-%e2%80%93-ham-luong\"><\/span>2. D\u1ea1ng b\u00e0o ch\u1ebf &#8211; H\u00e0m l\u01b0\u1ee3ng:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong><em>D\u1ea1ng thu\u1ed1c v\u00e0 h\u00e0m l\u01b0\u1ee3ng<\/em><\/strong><\/p>\n<p>Vi\u00ean n\u00e9n bao phim ph\u00f3ng th\u00edch k\u00e9o d\u00e0i:<\/p>\n<p>Komboglyze XR 5mg\/500mg M\u1ed7i vi\u00ean: Saxagliptin 5mg, metformin HCl 500mg.<\/p>\n<p>Komboglyze XR 5mg\/1000mg M\u1ed7i vi\u00ean: Saxagliptin 5mg, metformin HCl 1000mg.<\/p>\n<p><strong><em>Thu\u1ed1c tham kh\u1ea3o:<\/em><\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\"><strong><em>KOMBOGLYZE XR 5MG\/1000MG<\/em><\/strong><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><em>M\u1ed7i vi\u00ean ph\u00f3ng th\u00edch k\u00e9o d\u00e0i c\u00f3 ch\u1ee9a:<\/em><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Metformin HCl<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>1000 mg<\/td>\n<\/tr>\n<tr>\n<td>Saxagliptin<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>5 mg<\/td>\n<\/tr>\n<tr>\n<td>T\u00e1 d\u01b0\u1ee3c<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>v\u1eeba \u0111\u1ee7 (Xem m\u1ee5c 6.1)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-55495\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-1000mg-metformin-saxagliptin.png\" alt=\"Komboglyze XR 5mg\/1000mg (Metformin + Saxagliptin)\" width=\"742\" height=\"429\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-1000mg-metformin-saxagliptin.png 942w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-1000mg-metformin-saxagliptin-300x173.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-1000mg-metformin-saxagliptin-768x444.png 768w\" sizes=\"auto, (max-width: 742px) 100vw, 742px\" \/><\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\"><strong><em>KOMBOGLYZE XR 5MG\/500MG<\/em><\/strong><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><em>M\u1ed7i vi\u00ean ph\u00f3ng th\u00edch k\u00e9o d\u00e0i c\u00f3 ch\u1ee9a:<\/em><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Metformin HCl<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>500 mg<\/td>\n<\/tr>\n<tr>\n<td>Saxagliptin<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>5 mg<\/td>\n<\/tr>\n<tr>\n<td>T\u00e1 d\u01b0\u1ee3c<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>v\u1eeba \u0111\u1ee7 (Xem m\u1ee5c 6.1)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-55496\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-500mg-metformin-saxagliptin.png\" alt=\"Komboglyze XR 5mg\/500mg (Metformin + Saxagliptin)\" width=\"735\" height=\"454\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-500mg-metformin-saxagliptin.png 935w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-500mg-metformin-saxagliptin-300x185.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/komboglyze-xr-5mg-500mg-metformin-saxagliptin-768x474.png 768w\" sizes=\"auto, (max-width: 735px) 100vw, 735px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3-video-by-pharmog\"><\/span>3. Video by Pharmog:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>[VIDEO D\u01af\u1ee2C L\u00dd]<\/strong><\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<\/p>\n<p>\u25ba K\u1ecbch B\u1ea3n: PharmogTeam<\/p>\n<p>\u25ba Youtube: https:\/\/www.youtube.com\/c\/pharmog<\/p>\n<p>\u25ba Facebook: https:\/\/www.facebook.com\/pharmog\/<\/p>\n<p>\u25ba Group : H\u1ed9i nh\u1eefng ng\u01b0\u1eddi m\u00ea d\u01b0\u1ee3c l\u00fd<\/p>\n<p>\u25ba Instagram : https:\/\/www.instagram.com\/pharmogvn\/<\/p>\n<p>\u25ba Website: pharmog.com<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4-ung-dung-lam-sang\"><\/span>4. \u1ee8ng d\u1ee5ng l\u00e2m s\u00e0ng:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"41-chi-dinh\"><\/span>4.1. Ch\u1ec9 \u0111\u1ecbnh:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>KOMBOGLYZE XR \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 cho ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang v\u00e0 luy\u1ec7n t\u1eadp nh\u1eb1m ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n t\u1eeb 18 tu\u1ed5i tr\u1edf l\u00ean b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 kh\u00f4ng ki\u1ec3m so\u00e1t t\u1ed1t sau khi d\u00f9ng li\u1ec1u dung n\u1ea1p t\u1ed1i \u0111a c\u1ee7a metformin \u0111\u01a1n tr\u1ecb li\u1ec7u ho\u1eb7c nh\u1eefng b\u1ec7nh nh\u00e2n \u0111ang \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 metformin \u1edf d\u1ea1ng vi\u00ean n\u00e9n ch\u1ee9a ho\u1ea1t ch\u1ea5t ri\u00eang bi\u1ec7t.<\/p>\n<p>KOMBOGLYZE XR c\u0169ng \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh ph\u1ed1i h\u1ee3p v\u1edbi insulin (v\u00ed d\u1ee5 nh\u01b0 li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p 3 thu\u1ed1c) \u0111\u1ec3 h\u1ed7 tr\u1ee3 cho ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang v\u00e0 luy\u1ec7n t\u1eadp nh\u1eb1m ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n t\u1eeb 18 tu\u1ed5i tr\u1edf l\u00ean b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 khi insulin v\u00e0 metformin v\u1eabn ch\u01b0a ki\u1ec3m so\u00e1t t\u1ed1t \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p>KOMBOGLYZE XR c\u0169ng \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh ph\u1ed1i h\u1ee3p v\u1edbi 1 thu\u1ed1c sulfonylur\u00ea (v\u00ed d\u1ee5 nh\u01b0 li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p 3 thu\u1ed1c) \u0111\u1ec3 h\u1ed7 tr\u1ee3 cho ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang v\u00e0 luy\u1ec7n t\u1eadp nh\u1eb1m ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n t\u1eeb 18 tu\u1ed5i tr\u1edf l\u00ean b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 ch\u01b0a ki\u1ec3m so\u00e1t t\u1ed1t \u0111\u01b0\u1eddng huy\u1ebft sau khi d\u00f9ng li\u1ec1u dung n\u1ea1p t\u1ed1i \u0111a c\u1ee7a c\u1ea3 metformin v\u00e0 sulfonylur\u00ea.<\/p>\n<p><em>Gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng<\/em><\/p>\n<p>Kh\u00f4ng n\u00ean s\u1eed d\u1ee5ng KOMBOGLYZE XR cho b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 1 ho\u1eb7c nhi\u1ec5m ceto-acid do \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng.<\/p>\n<p>KOMBOGLYZE XR ch\u01b0a \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u \u1edf b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed vi\u00eam t\u1ee5y. Hi\u1ec7n ch\u01b0a r\u00f5 b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed vi\u00eam t\u1ee5y khi s\u1eed d\u1ee5ng KOMBOGLYZE XR c\u00f3 l\u00e0m t\u0103ng nguy c\u01a1 b\u1ecb vi\u00eam t\u1ee5y hay kh\u00f4ng (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"42-lieu-dung-%e2%80%93-cach-dung\"><\/span>4.2. Li\u1ec1u d\u00f9ng &#8211; C\u00e1ch d\u00f9ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong><em>C\u00e1ch d\u00f9ng<\/em><\/strong> :<\/p>\n<p>D\u00f9ng \u0111\u01b0\u1eddng u\u1ed1ng. Vi\u00ean KOMBOGLYZE XR th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ng\u00e0y 1 l\u1ea7n v\u00e0o b\u1eefa \u0103n t\u1ed1i, \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u d\u1ea7n d\u1ea7n \u0111\u1ec3 l\u00e0m gi\u1ea3m t\u00e1c d\u1ee5ng ph\u1ee5 tr\u00ean \u0111\u01b0\u1eddng ti\u00eau h\u00f3a do Metformin.<\/p>\n<p>B\u1ec7nh nh\u00e2n c\u1ea7n \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o u\u1ed1ng nguy\u00ean vi\u00ean, kh\u00f4ng \u0111\u01b0\u1ee3c b\u1ebb, c\u1eaft hay nhai vi\u00ean KOMBOGLYZE XR. Th\u1ec9nh tho\u1ea3ng, t\u00e1 d\u01b0\u1ee3c c\u1ee7a KOMBOGLYZE XR s\u1ebd \u0111\u01b0\u1ee3c \u0111\u00e0o th\u1ea3i d\u01b0\u1edbi d\u1ea1ng vi\u00ean bao m\u1ec1m ng\u1eadm n\u01b0\u1edbc \u1edf trong ph\u00e2n, c\u00f3 th\u1ec3 tr\u00f4ng t\u01b0\u01a1ng t\u1ef1 nh\u01b0 vi\u00ean thu\u1ed1c ban \u0111\u1ea7u.<\/p>\n<p><strong><em>Li\u1ec1u d\u00f9ng:<\/em><\/strong><\/p>\n<p><em>Li\u1ec1u khuy\u1ebfn c\u00e1o:<\/em><\/p>\n<p>Li\u1ec1u d\u00f9ng c\u1ee7a KOMBOGLYZE XR n\u00ean \u0111\u01b0\u1ee3c c\u1ee5 th\u1ec3 h\u00f3a tr\u00ean t\u1eebng ng\u01b0\u1eddi b\u1ec7nh d\u1ef1a v\u00e0o t\u00ecnh tr\u1ea1ng b\u1ec7nh hi\u1ec7n t\u1ea1i, hi\u1ec7u qu\u1ea3 v\u00e0 kh\u1ea3 n\u0103ng dung n\u1ea1p.<\/p>\n<p>Vi\u00ean KOMBOGLYZE XR th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ng\u00e0y 1 l\u1ea7n.<\/p>\n<p>Li\u1ec1u kh\u1edfi \u0111\u1ea7u khuy\u1ebfn c\u00e1o c\u1ee7a KOMBOGLYZE XR tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n c\u1ea7n 5mg Saxagliptin v\u00e0 hi\u1ec7n t\u1ea1i ch\u01b0a \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi Metformin l\u00e0 1 vi\u00ean c\u00f3 h\u00e0m l\u01b0\u1ee3ng 5mg Saxagliptin\/500mg Metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i, u\u1ed1ng 1 l\u1ea7n m\u1ed7i ng\u00e0y v\u1edbi li\u1ec1u \u0111i\u1ec1u ch\u1ec9nh t\u0103ng d\u1ea7n \u0111\u1ec3 gi\u1ea3m t\u00e1c d\u1ee5ng ph\u1ee5 tr\u00ean d\u1ea1 d\u00e0y &#8211; ru\u1ed9t g\u00e2y ra do Metformin.<\/p>\n<p>B\u1ec7nh nh\u00e2n c\u1ea7n 2,5mg Saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi Metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i c\u00f3 th\u1ec3 \u0111i\u1ec1u tr\u1ecb v\u1edbi vi\u00ean KOMBOGLYZE XR 2,5mg\/1000mg. Nh\u1eefng b\u1ec7nh nh\u00e2n c\u1ea7n d\u00f9ng li\u1ec1u 2,5mg Saxagliptin nh\u01b0ng kh\u00f4ng c\u1ea7n d\u00f9ng Metformin ho\u1eb7c c\u1ea7n d\u00f9ng li\u1ec1u Metformin cao h\u01a1n 1000mg th\u00ec n\u00ean s\u1eed d\u1ee5ng thu\u1ed1c c\u00f3 ch\u1ee9a c\u00e1c th\u00e0nh ph\u1ea7n ho\u1ea1t ch\u1ea5t ri\u00eang r\u1ebd.<\/p>\n<p>Li\u1ec1u d\u00f9ng h\u00e0ng ng\u00e0y khuy\u1ebfn c\u00e1o t\u1ed1i \u0111a l\u00e0 5mg Saxagliptin v\u00e0 2000mg Metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i.<\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u chuy\u00ean bi\u1ec7t \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a KOMBOGLYZE XR tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n m\u00e0 tr\u01b0\u1edbc \u0111\u00f3 c\u00f3 \u0111i\u1ec1u tr\u1ecb v\u1edbi c\u00e1c thu\u1ed1c ch\u1ed1ng t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft kh\u00e1c v\u00e0 chuy\u1ec3n sang s\u1eed d\u1ee5ng KOMBOGLYZE XR. B\u1ea5t c\u1ee9 s\u1ef1 thay \u0111\u1ed5i v\u1ec1 li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 n\u00ean \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t v\u00e0 theo d\u00f5i th\u00edch h\u1ee3p v\u00ec c\u00f3 th\u1ec3 x\u1ea3y ra nh\u1eefng bi\u1ebfn \u0111\u1ed9ng tr\u00ean vi\u1ec7c ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p><em>\u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi li\u1ec1u dung n\u1ea1p t\u1ed1i \u0111a c\u1ee7a Metformin \u0111\u01a1n tr\u1ecb li\u1ec7u<\/em><\/p>\n<p>\u1ede c\u00e1c b\u1ec7nh nh\u00e2n \u0111ang \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi Metformin, n\u00ean ch\u1ecdn li\u1ec1u KOMBOGLYZE XR c\u00f3 th\u1ec3 cung c\u1ea5p \u0111\u01b0\u1ee3c Metformin t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi li\u1ec1u Metformin \u0111ang \u0111i\u1ec1u tr\u1ecb ho\u1eb7c v\u1edbi li\u1ec1u tr\u1ecb li\u1ec7u th\u00edch h\u1ee3p g\u1ea7n nh\u1ea5t. Sau khi chuy\u1ec3n \u0111\u1ed5i t\u1eeb li\u1ec1u Metformin t\u00e1c d\u1ee5ng ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi sang Metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i, c\u1ea7n ti\u1ebfn h\u00e0nh theo d\u00f5i ch\u1eb7t ch\u1ebd vi\u1ec7c ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft v\u00e0 \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u cho ph\u00f9 h\u1ee3p.<\/p>\n<p><em>\u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n chuy\u1ec3n t\u1eeb d\u1ea1ng ph\u1ed1i h\u1ee3p vi\u00ean ch\u1ee9a Saxagliptin v\u00e0 vi\u00ean ch\u1ee9a Metformin ri\u00eang l\u1ebb<\/em><\/p>\n<p>B\u1ec7nh nh\u00e2n chuy\u1ec3n t\u1eeb d\u1ea1ng ph\u1ed1i h\u1ee3p vi\u00ean ch\u1ee9a Saxagliptin v\u00e0 vi\u00ean ch\u1ee9a Metformin ri\u00eang l\u1ebb n\u00ean ch\u1ecdn li\u1ec1u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi li\u1ec1u Saxagliptin v\u00e0 Metformin \u0111ang \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p><em>\u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 khi ph\u1ed1i h\u1ee3p Insulin v\u00e0 Metformin, ho\u1eb7c \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n \u0111\u00e3 ki\u1ec3m so\u00e1t \u1ed5n \u0111\u1ecbnh v\u1edbi li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p 3 thu\u1ed1c Insulin, Metformin v\u00e0 Saxagliptin d\u01b0\u1edbi d\u1ea1ng thu\u1ed1c ch\u1ee9a t\u1eebng ho\u1ea1t ch\u1ea5t ri\u00eang l\u1ebb.<\/em><\/p>\n<p>N\u00ean ch\u1ecdn li\u1ec1u KOMBOGLYZE XR c\u00f3 th\u1ec3 cung c\u1ea5p Saxagliptin 5mg v\u00e0 li\u1ec1u Metformin t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi li\u1ec1u Metformin \u0111ang \u0111i\u1ec1u tr\u1ecb. Khi s\u1eed d\u1ee5ng KOMBOGLYZE XR ph\u1ed1i h\u1ee3p v\u1edbi Insulin, n\u00ean s\u1eed d\u1ee5ng li\u1ec1u th\u1ea5p Insulin \u0111\u1ec3 h\u1ea1n ch\u1ebf nguy c\u01a1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p><em>\u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea9y \u0111\u1ee7 v\u1edbi li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p h\u1ee3p thu\u1ed1c Sulfonylur\u00ea v\u00e0 Metformin, ho\u1eb7c \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n chuy\u1ec3n t\u1eeb li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p 3 thu\u1ed1c Saxagliptin, Metformin v\u00e0 Sulfonylur\u00ea d\u01b0\u1edbi d\u1ea1ng thu\u1ed1c ch\u1ee9a t\u1eebng ho\u1ea1t ch\u1ea5t ri\u00eang l\u1ebb.<\/em><\/p>\n<p>N\u00ean ch\u1ecdn li\u1ec1u KOMBOGLYZE XR c\u00f3 th\u1ec3 cung c\u1ea5p Saxagliptin 5mg v\u00e0 li\u1ec1u Metformin t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi li\u1ec1u Metformin \u0111ang \u0111i\u1ec1u tr\u1ecb. Khi s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p KOMBOGLYZE XR v\u1edbi 1 thu\u1ed1c Sulfonylur\u00ea, n\u00ean s\u1eed d\u1ee5ng li\u1ec1u th\u1ea5p Sulfonylur\u00ea \u0111\u1ec3 h\u1ea1n ch\u1ebf nguy c\u01a1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p><em>Khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng thu\u1ed1c tr\u00ean b\u1ec7nh nh\u00e2n suy th\u1eadn<\/em><\/p>\n<p>\u0110\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng th\u1eadn tr\u01b0\u1edbc khi kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR v\u00e0 \u0111\u00e1nh gi\u00e1 \u0111\u1ecbnh k\u1ef3 sau \u0111\u00f3.<\/p>\n<p>Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh KOMBOGLYZE XR tr\u00ean b\u1ec7nh nh\u00e2n c\u00f3 eGFR d\u01b0\u1edbi 30 mL\/ph\u00fat\/1,73m2.<\/p>\n<p>Kh\u00f4ng khuy\u1ebfn c\u00e1o kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR \u1edf b\u1ec7nh nh\u00e2n c\u00f3 eGFR n\u1eb1m trong kho\u1ea3ng 30-45 mL\/ph\u00fat\/1,73m2.<\/p>\n<p>\u1ede b\u1ec7nh nh\u00e2n \u0111ang s\u1eed d\u1ee5ng KOMBOGLYZE XR v\u00e0 c\u00f3 eGFR gi\u1ea3m xu\u1ed1ng d\u01b0\u1edbi 45 mL\/ph\u00fat\/1,73m2, \u0111\u00e1nh gi\u00e1 nguy c\u01a1 \u2013 l\u1ee3i \u00edch khi ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb v\u00e0 gi\u1edbi h\u1ea1n li\u1ec1u saxagliptin \u0111\u1ebfn 2,5 mg m\u1ed9t l\u1ea7n m\u1ed7i ng\u00e0y.<\/p>\n<p>Ng\u1eebng s\u1eed d\u1ee5ng KOMBOGLYZE XR n\u1ebfu b\u1ec7nh nh\u00e2n c\u00f3 eGFR gi\u1ea3m xu\u1ed1ng d\u01b0\u1edbi 30 mL\/ph\u00fat\/1,73m2 (xem m\u1ee5c Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, m\u1ee5c C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Ng\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c khi th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh c\u00f3 s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang ch\u1ee9a iod<\/em><\/p>\n<p>Tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 eGFR n\u1eb1m trong kho\u1ea3ng t\u1eeb 30-60 mL\/ph\u00fat\/1,73m2, tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n ti\u1ec1n s\u1eed b\u1ec7nh l\u00fd v\u1ec1 gan, nghi\u1ec7n r\u01b0\u1ee3u ho\u1eb7c suy tim, ho\u1eb7c tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n s\u1ebd s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang ch\u1ee9a iod qua \u0111\u01b0\u1eddng \u0111\u1ed9ng m\u1ea1ch, ng\u1eebng KOMBOGLYZE XR tr\u01b0\u1edbc ho\u1eb7c t\u1ea1i th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh c\u00f3 s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang ch\u1ee9a iod. \u0110\u00e1nh gi\u00e1 l\u1ea1i ch\u1ec9 s\u1ed1 eGFR sau khi chi\u1ebfu ch\u1ee5p 48 gi\u1edd, s\u1eed d\u1ee5ng l\u1ea1i KOMBOGLYZE XR n\u1ebfu ch\u1ee9c n\u0103ng th\u1eadn \u1ed5n \u0111\u1ecbnh (xem m\u1ee5c C\u1ea3nh b\u00e1o).<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h3><span class=\"ez-toc-section\" id=\"43-chong-chi-dinh\"><\/span>4.3. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>KOMBOGLYZE XR ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh \u1edf c\u00e1c b\u1ec7nh nh\u00e2n sau:<\/p>\n<p>B\u1ec7nh nh\u00e2n suy th\u1eadn n\u1eb7ng (eGFR d\u01b0\u1edbi 30 mL\/ph\u00fat\/1,73m2) (xem m\u1ee5c C\u1ea3nh b\u00e1o)<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u00e3 c\u00f3 ti\u1ec1n s\u1eed qu\u00e1 m\u1eabn v\u1edbi metformin<\/p>\n<p>Nhi\u1ec5m toan chuy\u1ec3n h\u00f3a c\u1ea5p t\u00ednh hay m\u00e3n t\u00ednh, k\u1ec3 c\u1ea3 nhi\u1ec5m toan ceton do \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng. B\u1ec7nh nh\u00e2n nhi\u1ec5m ceto-acid do \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng n\u00ean \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi insulin.<\/p>\n<p>Ti\u1ec1n s\u1eed ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn nghi\u00eam tr\u1ecdng v\u1edbi KOMBOGLYZE XR ho\u1eb7c saxagliptin nh\u01b0 ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7, ph\u00f9 m\u1ea1ch ho\u1eb7c c\u00e1c t\u00ecnh tr\u1ea1ng da tr\u00f3c v\u1ea3y (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"44-than-trong\"><\/span>4.4 Th\u1eadn tr\u1ecdng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>Nhi\u1ec5m acid lactic<\/em><\/p>\n<p>Qu\u00e1 tr\u00ecnh gi\u00e1m s\u00e1t h\u1eadu m\u00e3i \u0111\u00e3 ghi nh\u1eadn nh\u1eefng ca nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin, bao g\u1ed3m c\u1ea3 tr\u01b0\u1eddng h\u1ee3p t\u1eed vong, gi\u1ea3m th\u00e2n nhi\u1ec7t, t\u1ee5t huy\u1ebft \u00e1p, lo\u1ea1n nh\u1ecbp ch\u1eadm k\u00e9o d\u00e0i. Kh\u1edfi ph\u00e1t c\u1ee7a t\u00ecnh tr\u1ea1ng nhi\u1ec5m toan acid lactic li\u00ean quan \u0111\u1ebfn metformin th\u01b0\u1eddng kh\u00f4ng d\u1ec5 ph\u00e1t hi\u1ec7n, k\u00e8m theo c\u00e1c tri\u1ec7u ch\u1ee9ng kh\u00f4ng \u0111i\u1ec3n h\u00ecnh nh\u01b0 kh\u00f3 ch\u1ecbu, \u0111au c\u01a1, suy h\u00f4 h\u1ea5p, l\u01a1 m\u01a1 v\u00e0 \u0111au b\u1ee5ng. Nhi\u1ec5m toan acid lactic li\u00ean quan \u0111\u1ebfn metformin \u0111\u01b0\u1ee3c \u0111\u1eb7c tr\u01b0ng b\u1eb1ng n\u1ed3ng \u0111\u1ed9 lactat t\u0103ng l\u00ean trong m\u00e1u (&gt;5 mmol\/L), kho\u1ea3ng tr\u1ed1ng anion (kh\u00f4ng c\u00f3 b\u1eb1ng ch\u1ee9ng c\u1ee7a keto ni\u1ec7u ho\u1eb7c keto m\u00e1u), t\u0103ng t\u1ef7 l\u1ec7 lactat\/pyruvat v\u00e0 n\u1ed3ng \u0111\u1ed9 metformin huy\u1ebft t\u01b0\u01a1ng n\u00f3i chung t\u0103ng &gt;5 mcg\/mL.<\/p>\n<p>Y\u1ebfu t\u1ed1 nguy c\u01a1 c\u1ee7a nhi\u1ec5m toan acid lactic li\u00ean quan \u0111\u1ebfn metformin bao g\u1ed3m suy th\u1eadn, s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi m\u1ed9t s\u1ed1 thu\u1ed1c nh\u1ea5t \u0111\u1ecbnh (v\u00ed d\u1ee5 c\u00e1c ch\u1ea5t \u1ee9c ch\u1ebf carbonic anhydrase nh\u01b0 topiramat), t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean, c\u00f3 th\u1ef1c hi\u1ec7n chi\u1ebfu ch\u1ee5p s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang, ph\u1eabu thu\u1eadt v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 thu\u1eadt kh\u00e1c, t\u00ecnh tr\u1ea1ng gi\u1ea3m oxy h\u00edt v\u00e0o (v\u00ed d\u1ee5 suy tim sung huy\u1ebft c\u1ea5p), u\u1ed1ng nhi\u1ec1u r\u01b0\u1ee3u v\u00e0 suy gan.<\/p>\n<p>C\u00e1c bi\u1ec7n ph\u00e1p gi\u1ea3m thi\u1ec3u nguy c\u01a1 v\u00e0 x\u1eed tr\u00ed nhi\u1ec5m toan acid lactic li\u00ean quan \u0111\u1ebfn metformin \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 cao \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y chi ti\u1ebft trong t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c (m\u1ee5c Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 C\u00e1ch d\u00f9ng, Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, C\u1ea3nh b\u00e1o, T\u01b0\u01a1ng t\u00e1c v\u00e0 S\u1eed d\u1ee5ng thu\u1ed1c tr\u00ean nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u1eb7c bi\u1ec7t).<\/p>\n<p>N\u1ebfu nghi ng\u1edd c\u00f3 toan lactic li\u00ean quan \u0111\u1ebfn metformin, n\u00ean ng\u1eebng s\u1eed d\u1ee5ng KOMBOGLYZE XR, nhanh ch\u00f3ng \u0111\u01b0a b\u1ec7nh nh\u00e2n \u0111\u1ebfn b\u1ec7nh vi\u1ec7n v\u00e0 ti\u1ebfn h\u00e0nh c\u00e1c bi\u1ec7n ph\u00e1p x\u1eed tr\u00ed. \u1ede nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR, \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n toan lactic ho\u1eb7c nghi ng\u1edd c\u00f3 kh\u1ea3 n\u0103ng cao b\u1ecb toan lactic, khuy\u1ebfn c\u00e1o nhanh ch\u00f3ng l\u1ecdc m\u00e1u \u0111\u1ec3 \u0111i\u1ec1u ch\u1ec9nh t\u00ecnh tr\u1ea1ng nhi\u1ec5m toan v\u00e0 lo\u1ea1i b\u1ecf ph\u1ea7n metformin \u0111\u00e3 b\u1ecb t\u00edch l\u0169y (metformin hydroclorid c\u00f3 th\u1ec3 th\u1ea9m t\u00e1ch \u0111\u01b0\u1ee3c v\u1edbi \u0111\u1ed9 thanh th\u1ea3i 170 mL\/ph\u00fat trong \u0111i\u1ec1u ki\u1ec7n huy\u1ebft \u0111\u1ed9ng t\u1ed1t). L\u1ecdc m\u00e1u c\u00f3 th\u1ec3 l\u00e0m \u0111\u1ea3o ng\u01b0\u1ee3c tri\u1ec7u ch\u1ee9ng v\u00e0 h\u1ed3i ph\u1ee5c.<\/p>\n<p>H\u01b0\u1edbng d\u1eabn cho b\u1ec7nh nh\u00e2n v\u00e0 ng\u01b0\u1eddi nh\u00e0 v\u1ec1 c\u00e1c tri\u1ec7u ch\u1ee9ng c\u1ee7a toan lactic v\u00e0 n\u1ebfu nh\u1eefng tri\u1ec7u ch\u1ee9ng n\u00e0y x\u1ea3y ra, c\u1ea7n ng\u1eebng thu\u1ed1c KOMBOGLYZE XR v\u00e0 b\u00e1o c\u00e1o nh\u1eefng tri\u1ec7u ch\u1ee9ng n\u00e0y cho b\u00e1c s\u1ef9.<\/p>\n<p>\u0110\u1ed1i v\u1edbi m\u1ed7i y\u1ebfu t\u1ed1 l\u00e0m t\u0103ng nguy c\u01a1 nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin, nh\u1eefng khuy\u1ebfn c\u00e1o nh\u1eb1m gi\u00fap gi\u1ea3m thi\u1ec3u nguy c\u01a1 v\u00e0 x\u1eed tr\u00ed t\u00ecnh tr\u1ea1ng toan lactic li\u00ean quan \u0111\u1ebfn metformin, c\u1ee5 th\u1ec3 nh\u01b0 sau:<\/p>\n<p>Suy th\u1eadn<\/p>\n<p>Nh\u1eefng ca nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin trong qu\u00e1 tr\u00ecnh gi\u00e1m s\u00e1t thu\u1ed1c h\u1eadu m\u00e3i x\u1ea3y ra ch\u1ee7 y\u1ebfu tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb suy th\u1eadn n\u1eb7ng. Nguy c\u01a1 t\u00edch l\u0169y metformin v\u00e0 nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin t\u0103ng l\u00ean theo m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng c\u1ee7a suy th\u1eadn b\u1edfi metformin \u0111\u01b0\u1ee3c th\u1ea3i tr\u1eeb ch\u1ee7 y\u1ebfu qua th\u1eadn. Khuy\u1ebfn c\u00e1o l\u00e2m s\u00e0ng d\u1ef1a tr\u00ean ch\u1ee9c n\u0103ng th\u1eadn c\u1ee7a b\u1ec7nh nh\u00e2n bao g\u1ed3m (xem m\u1ee5c Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 C\u00e1ch d\u00f9ng, D\u01b0\u1ee3c l\u00fd]:<\/p>\n<p>\u00b7 Tr\u01b0\u1edbc khi kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR c\u1ea7n \u01b0\u1edbc t\u00ednh m\u1ee9c \u0111\u1ed9 l\u1ecdc c\u1ea7u th\u1eadn (eGFR) c\u1ee7a b\u1ec7nh nh\u00e2n.<\/p>\n<p>\u00b7 Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh KOMBOGLYZE XR tr\u00ean b\u1ec7nh nh\u00e2n c\u00f3 eGFR d\u01b0\u1edbi 30 mL\/ph\u00fat\/1,73m2 (xem m\u1ee5c Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh).<\/p>\n<p>\u00b7 Kh\u00f4ng khuy\u1ebfn c\u00e1o kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR \u1edf b\u1ec7nh nh\u00e2n c\u00f3 eGFR n\u1eb1m trong kho\u1ea3ng 30-45 mL\/ph\u00fat\/1,73m2.<\/p>\n<p>\u00b7 Thu th\u1eadp d\u1eef li\u1ec7u v\u1ec1 eGFR \u00edt nh\u1ea5t 1 l\u1ea7n\/n\u0103m \u1edf t\u1ea5t c\u1ea3 c\u00e1c b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng KOMBOGLYZE XR. \u1ede b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ea3 n\u0103ng t\u0103ng nguy c\u01a1 suy th\u1eadn (v\u00ed d\u1ee5 nh\u01b0 ng\u01b0\u1eddi cao tu\u1ed5i), ch\u1ee9c n\u0103ng th\u1eadn n\u00ean \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 th\u01b0\u1eddng xuy\u00ean h\u01a1n.<\/p>\n<p>\u00b7 \u1ede b\u1ec7nh nh\u00e2n \u0111ang s\u1eed d\u1ee5ng KOMBOGLYZE XR v\u00e0 c\u00f3 eGFR gi\u1ea3m xu\u1ed1ng d\u01b0\u1edbi 45 mL\/ph\u00fat\/1,73m2, \u0111\u00e1nh gi\u00e1 nguy c\u01a1-l\u1ee3i \u00edch c\u1ee7a vi\u1ec7c ti\u1ebfp t\u1ee5c ph\u00e1c \u0111\u1ed3.<\/p>\n<p>T\u01b0\u01a1ng t\u00e1c thu\u1ed1c<\/p>\n<p>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi KOMBOGLYZE XR v\u1edbi m\u1ed9t s\u1ed1 thu\u1ed1c c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin: b\u1ec7nh nh\u00e2n suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn d\u1eabn t\u1edbi nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 v\u1ec1 m\u1eb7t huy\u1ebft \u0111\u1ed9ng, \u1ea3nh h\u01b0\u1edfng t\u1edbi c\u00e2n b\u1eb1ng acid-base ho\u1eb7c l\u00e0m t\u0103ng t\u00edch l\u0169y metformin (xem m\u1ee5c T\u01b0\u01a1ng t\u00e1c). V\u00ec v\u1eady, c\u00e2n nh\u1eafc theo d\u00f5i b\u1ec7nh nh\u00e2n th\u01b0\u1eddng xuy\u00ean h\u01a1n.<\/p>\n<p>B\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean<\/p>\n<p>Nguy c\u01a1 toan lactic li\u00ean quan \u0111\u1ebfn metformin t\u0103ng l\u00ean theo tu\u1ed5i c\u1ee7a b\u1ec7nh nh\u00e2n b\u1edfi b\u1ec7nh nh\u00e2n cao tu\u1ed5i c\u00f3 kh\u1ea3 n\u0103ng b\u1ecb suy gan, suy th\u1eadn, suy tim l\u1edbn h\u01a1n nh\u1eefng b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i h\u01a1n. C\u1ea7n \u0111\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng th\u1eadn th\u01b0\u1eddng xuy\u00ean h\u01a1n \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n l\u1edbn tu\u1ed5i.<\/p>\n<p>Th\u1ef1c hi\u1ec7n c\u00e1c x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n c\u00f3 s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang<\/p>\n<p>Ti\u00eam thu\u1ed1c c\u1ea3n quang v\u00e0o n\u1ed9i m\u1ea1ch \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111ang \u0111i\u1ec1u tr\u1ecb metformin c\u00f3 th\u1ec3 d\u1eabn t\u1edbi suy gi\u1ea3m c\u1ea5p t\u00ednh ch\u1ee9c n\u0103ng th\u1eadn v\u00e0 g\u00e2y ra toan lactic. Ng\u1eebng s\u1eed d\u1ee5ng KOMBOGLYZE XR tr\u01b0\u1edbc ho\u1eb7c t\u1ea1i th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n chi\u1ebfu ch\u1ee5p c\u00f3 s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang c\u00f3 ch\u1ee9a iod \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 eGFR n\u1eb1m trong kho\u1ea3ng 30-60 mL\/ph\u00fat\/1,73m2, nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed suy gan, nghi\u1ec7n r\u01b0\u1ee3u, suy tim ho\u1eb7c nh\u1eefng b\u1ec7nh nh\u00e2n s\u1ebd s\u1eed d\u1ee5ng thu\u1ed1c c\u1ea3n quang ch\u1ee9a iod theo \u0111\u01b0\u1eddng \u0111\u1ed9ng m\u1ea1ch. \u0110\u00e1nh gi\u00e1 l\u1ea1i eGFR 48 gi\u1edd sau khi chi\u1ebfu ch\u1ee5p v\u00e0 s\u1eed d\u1ee5ng l\u1ea1i KOMBOGLYZE XR n\u1ebfu ch\u1ee9c n\u0103ng th\u1eadn \u1ed5n \u0111\u1ecbnh.<\/p>\n<p>Ph\u1eabu thu\u1eadt ho\u1eb7c c\u00e1c ph\u1eabu thu\u1eadt kh\u00e1c<\/p>\n<p>S\u1ef1 l\u01b0u gi\u1eef th\u1ee9c \u0103n v\u00e0 d\u1ecbch trong qu\u00e1 tr\u00ecnh ph\u1eabu thu\u1eadt ho\u1eb7c th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 thu\u1eadt kh\u00e1c c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 gi\u1ea3m th\u1ec3 t\u00edch, t\u1ee5t huy\u1ebft \u00e1p v\u00e0 suy th\u1eadn. N\u00ean t\u1ea1m th\u1eddi ng\u1eebng s\u1eed d\u1ee5ng KOMBOGLYZE XR khi b\u1ec7nh nh\u00e2n b\u1ecb gi\u1edbi h\u1ea1n l\u01b0\u1ee3ng th\u1ee9c \u0103n v\u00e0 d\u1ecbch n\u1ea1p v\u00e0o.<\/p>\n<p>T\u00ecnh tr\u1ea1ng gi\u1ea3m oxy h\u00edt v\u00e0o<\/p>\n<p>Qu\u00e1 tr\u00ecnh theo d\u00f5i h\u1eadu m\u00e3i \u0111\u00e3 ghi nh\u1eadn m\u1ed9t s\u1ed1 ca nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin x\u1ea3y ra trong b\u1ec7nh c\u1ea3nh suy tim sung huy\u1ebft c\u1ea5p (\u0111\u1eb7c bi\u1ec7t khi c\u00f3 k\u00e8m theo gi\u1ea3m t\u01b0\u1edbi m\u00e1u v\u00e0 gi\u1ea3m oxy huy\u1ebft). Tr\u1ee5y tim m\u1ea1ch (s\u1ed1c), nh\u1ed3i m\u00e1u c\u01a1 tim c\u1ea5p, nhi\u1ec5m khu\u1ea9n huy\u1ebft v\u00e0 c\u00e1c b\u1ec7nh l\u00fd kh\u00e1c li\u00ean quan \u0111\u1ebfn gi\u1ea3m oxy huy\u1ebft c\u00f3 m\u1ed1i li\u00ean quan v\u1edbi toan lactic v\u00e0 c\u0169ng c\u00f3 th\u1ec3 g\u00e2y nit\u01a1 huy\u1ebft tr\u01b0\u1edbc th\u1eadn. Khi nh\u1eefng bi\u1ebfn c\u1ed1 n\u00e0y x\u1ea3y ra, ng\u1eebng KOMBOGLYZE XR.<\/p>\n<p>U\u1ed1ng r\u01b0\u1ee3u<\/p>\n<p>R\u01b0\u1ee3u c\u00f3 kh\u1ea3 n\u0103ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn t\u00e1c \u0111\u1ed9ng c\u1ee7a metformin l\u00ean chuy\u1ec3n h\u00f3a lactat v\u00e0 t\u1eeb \u0111\u00f3 c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 nhi\u1ec5m toan lactic li\u00ean quan \u0111\u1ebfn metformin. C\u1ea3nh b\u00e1o b\u1ec7nh nh\u00e2n kh\u00f4ng u\u1ed1ng r\u01b0\u1ee3u khi s\u1eed d\u1ee5ng KOMBOGLYZE XR.<\/p>\n<p>Suy gan<\/p>\n<p>B\u1ec7nh nh\u00e2n suy gan c\u00f3 th\u1ec3 ti\u1ebfn tri\u1ec3n th\u00e0nh toan lactic li\u00ean quan \u0111\u1ebfn metformin do suy gi\u1ea3m th\u1ea3i tr\u1eeb lactat d\u1eabn t\u1edbi t\u0103ng n\u1ed3ng \u0111\u1ed9 lactat trong m\u00e1u. V\u00ec v\u1eady, tr\u00e1nh s\u1eed d\u1ee5ng KOMBOGLYZE XR tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n b\u1ec7nh gan th\u00f4ng qua b\u1eb1ng ch\u1ee9ng x\u00e9t nghi\u1ec7m ho\u1eb7c l\u00e2m s\u00e0ng.<\/p>\n<p><em>Vi\u00eam t\u1ee5y<\/em><\/p>\n<p>Vi\u00eam t\u1ee5y c\u1ea5p \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn sau khi thu\u1ed1c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng. Sau khi b\u1eaft \u0111\u1ea7u s\u1eed d\u1ee5ng KOMBOGLYZE XR, b\u1ec7nh nh\u00e2n n\u00ean \u0111\u01b0\u1ee3c theo d\u00f5i c\u1ea9n th\u1eadn c\u00e1c d\u1ea5u hi\u1ec7u v\u00e0 tri\u1ec7u ch\u1ee9ng vi\u00eam t\u1ee5y. N\u1ebfu c\u00f3 nghi ng\u1edd b\u1ecb vi\u00eam t\u1ee5y, n\u00ean ng\u01b0ng s\u1eed d\u1ee5ng KOMBOGLYZE XR ngay v\u00e0 ti\u1ebfn h\u00e0nh bi\u1ec7n ph\u00e1p \u0111i\u1ec1u tr\u1ecb th\u00edch h\u1ee3p. Hi\u1ec7n ch\u01b0a r\u00f5 b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed vi\u00eam t\u1ee5y khi s\u1eed d\u1ee5ng KOMBOGLYZE XR c\u00f3 l\u00e0m t\u0103ng nguy c\u01a1 b\u1ecb vi\u00eam t\u1ee5y hay kh\u00f4ng.<\/p>\n<p>Trong nghi\u00ean c\u1ee9u \u0111\u00e1nh gi\u00e1 d\u1ef1 h\u1eadu tim m\u1ea1ch c\u1ee7a saxagliptin tr\u00ean b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng &#8211; huy\u1ebft kh\u1ed1i trong nh\u1ed3i m\u00e1u c\u01a1 tim (SAVOR), t\u1ef7 l\u1ec7 bi\u1ebfn c\u1ed1 vi\u00eam t\u1ee5y x\u00e1c \u0111\u1ecbnh sau khi hi\u1ec7u ch\u1ec9nh l\u00e0 0,3% \u1edf c\u1ea3 2 nh\u00f3m d\u00f9ng saxagliptin v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c trong d\u00e2n s\u1ed1 d\u1ef1 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb (ITT) (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p><em>\u0110\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng th\u1eadn<\/em><\/p>\n<p>Metformin \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft ch\u1ee7 y\u1ebfu qua th\u1eadn, nguy c\u01a1 t\u00edch l\u0169y metformin v\u00e0 nhi\u1ec5m acid lactic t\u0103ng theo m\u1ee9c \u0111\u1ed9 suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn. V\u00ec th\u1ebf, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh d\u00f9ng KOMBOGLYZE XR \u1edf c\u00e1c b\u1ec7nh nh\u00e2n suy th\u1eadn (xem ph\u1ea7n Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh).<\/p>\n<p>Tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u s\u1eed d\u1ee5ng KOMBOGLYZE XR, v\u00e0 \u00edt nh\u1ea5t l\u00e0 m\u1ed7i n\u0103m sau \u0111\u00f3, n\u00ean \u0111\u00e1nh gi\u00e1 v\u00e0 x\u00e1c nh\u1eadn ch\u1ee9c n\u0103ng th\u1eadn l\u00e0 b\u00ecnh th\u01b0\u1eddng. \u1ede c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c d\u1ef1 \u0111o\u00e1n l\u00e0 c\u00f3 ti\u1ebfn tri\u1ec3n suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn (v\u00ed d\u1ee5, ng\u01b0\u1eddi cao tu\u1ed5i), n\u00ean \u0111\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng th\u1eadn th\u01b0\u1eddng xuy\u00ean h\u01a1n v\u00e0 ng\u01b0ng d\u00f9ng KOMBOGLYZE XR n\u1ebfu c\u00f3 b\u1eb1ng ch\u1ee9ng suy th\u1eadn.<\/p>\n<p><em>\u0110\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng gan<\/em><\/p>\n<p>C\u00f3 v\u00e0i tr\u01b0\u1eddng h\u1ee3p nhi\u1ec5m acid lactic \u1edf b\u1ec7nh nh\u00e2n suy gan c\u00f3 s\u1eed d\u1ee5ng metformin. V\u00ec th\u1ebf, kh\u00f4ng khuy\u1ebfn c\u00e1o d\u00f9ng KOMBOGLYZE XR cho b\u1ec7nh nh\u00e2n suy gan.<\/p>\n<p><em>N\u1ed3ng \u0111\u1ed9 vitamin B12<\/em><\/p>\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng c\u1ee7a metformin ti\u1ebfn h\u00e0nh trong 29 tu\u1ea7n, \u0111\u00e3 ghi nh\u1eadn s\u1ef1 gi\u1ea3m d\u01b0\u1edbi m\u1ee9c b\u00ecnh th\u01b0\u1eddng n\u1ed3ng \u0111\u1ed9 vitamin B12 trong huy\u1ebft thanh v\u1ed1n b\u00ecnh th\u01b0\u1eddng tr\u01b0\u1edbc \u0111\u00f3, m\u00e0 kh\u00f4ng c\u00f3 bi\u1ec3u hi\u1ec7n l\u00e2m s\u00e0ng tr\u00ean kho\u1ea3ng 7% b\u1ec7nh nh\u00e2n. M\u1ee9c gi\u1ea3m n\u00e0y c\u00f3 th\u1ec3 do s\u1ef1 can thi\u1ec7p \u0111\u1ebfn kh\u1ea3 n\u0103ng h\u1ea5p thu vitamin B12 t\u1eeb ph\u1ee9c h\u1ee3p y\u1ebfu t\u1ed1 n\u1ed9i t\u1ea1i c\u1ee7a vitamin B12, tuy nhi\u00ean, r\u1ea5t hi\u1ebfm khi li\u00ean quan v\u1edbi thi\u1ebfu m\u00e1u v\u00e0 s\u1ebd nhanh ch\u00f3ng h\u1ed3i ph\u1ee5c khi ng\u01b0ng metformin ho\u1eb7c b\u1ed5 sung vitamin B12. B\u1ec7nh nh\u00e2n d\u00f9ng KOMBOGLYZE XR \u0111\u01b0\u1ee3c khuy\u00ean n\u00ean ki\u1ec3m tra c\u00e1c th\u00f4ng s\u1ed1 huy\u1ebft h\u1ecdc h\u00e0ng n\u0103m, v\u00e0 n\u1ebfu c\u00f3 b\u1ea5t c\u1ee9 c\u00e1c b\u1ea5t th\u01b0\u1eddng n\u00e0o bi\u1ec3u hi\u1ec7n n\u00ean \u0111\u01b0\u1ee3c kh\u1ea3o s\u00e1t v\u00e0 x\u1eed tr\u00ed th\u00edch h\u1ee3p (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p>N\u1ed3ng \u0111\u1ed9 vitamin B12 d\u01b0\u1edbi m\u1ee9c b\u00ecnh th\u01b0\u1eddng c\u00f3 khuynh h\u01b0\u1edbng g\u1eb7p \u1edf m\u1ed9t s\u1ed1 c\u00e1 th\u1ec3 (nh\u01b0 nh\u1eefng ng\u01b0\u1eddi thi\u1ebfu vitamin B12 ho\u1eb7c do u\u1ed1ng canxi ho\u1eb7c do k\u00e9m h\u1ea5p thu). \u1ede nh\u1eefng b\u1ec7nh nh\u00e2n n\u00e0y, \u0111\u1ecbnh l\u01b0\u1ee3ng n\u1ed3ng \u0111\u1ed9 B12 huy\u1ebft thanh th\u01b0\u1eddng quy trong m\u1ed7i 2-3 n\u0103m c\u00f3 th\u1ec3 r\u1ea5t h\u1eefu \u00edch.<\/p>\n<p><em>S\u1eed d\u1ee5ng r\u01b0\u1ee3u (alcohol)<\/em><\/p>\n<p>Alcohol c\u00f3 th\u1ec3 l\u00e0m t\u0103ng c\u01b0\u1eddng t\u00e1c d\u1ee5ng c\u1ee7a metformin tr\u00ean chuy\u1ec3n h\u00f3a lactate. B\u1ec7nh nh\u00e2n n\u00ean \u0111\u01b0\u1ee3c c\u1ea3nh b\u00e1o h\u1ea1n ch\u1ebf u\u1ed1ng r\u01b0\u1ee3u trong khi d\u00f9ng thu\u1ed1c KOMBOGLYZE XR.<\/p>\n<p><em>Ph\u1eabu thu\u1eadt<\/em><\/p>\n<p>N\u00ean t\u1ea1m th\u1eddi ng\u01b0ng s\u1eed d\u1ee5ng thu\u1ed1c KOMBOGLYZE XR khi th\u1ef1c hi\u1ec7n b\u1ea5t k\u1ef3 ph\u1eabu thu\u1eadt n\u00e0o (ngo\u1ea1i tr\u1eeb ti\u1ec3u ph\u1eabu kh\u00f4ng li\u00ean quan \u0111\u1ebfn vi\u1ec7c h\u1ea1n ch\u1ebf s\u1eed d\u1ee5ng th\u1ee9c \u0103n v\u00e0 \u0111\u1ed3 u\u1ed1ng), v\u00e0 kh\u00f4ng n\u00ean b\u1eaft \u0111\u1ea7u d\u00f9ng l\u1ea1i thu\u1ed1c cho \u0111\u1ebfn khi b\u1ec7nh nh\u00e2n \u0103n u\u1ed1ng tr\u1edf l\u1ea1i v\u00e0 ch\u1ee9c n\u0103ng th\u1eadn \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u00e0 b\u00ecnh th\u01b0\u1eddng.<\/p>\n<p><em>Nh\u1eefng thay \u0111\u1ed5i tr\u00ean t\u00ecnh tr\u1ea1ng l\u00e2m s\u00e0ng c\u1ee7a b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t tr\u01b0\u1edbc \u0111\u00e2y<\/em><\/p>\n<p>Tr\u00ean b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 tr\u01b0\u1edbc \u0111\u00e2y \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t t\u1ed1t b\u1eb1ng KOMBOGLYZE XR, c\u00f3 di\u1ec5n ti\u1ebfn x\u00e9t nghi\u1ec7m b\u1ea5t th\u01b0\u1eddng ho\u1eb7c t\u00ecnh tr\u1ea1ng l\u00e2m s\u00e0ng x\u1ea5u \u0111i (\u0111\u1eb7c bi\u1ec7t l\u00e0 nh\u1eefng t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00fd m\u01a1 h\u1ed3 v\u00e0 ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c) n\u00ean \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 k\u1ecbp th\u1eddi nh\u1eb1m t\u00ecm b\u1eb1ng ch\u1ee9ng c\u1ee7a nhi\u1ec5m toan ceto-acid ho\u1eb7c nhi\u1ec5m acid lactic. C\u00e1c ch\u1ec9 s\u1ed1 \u0111\u00e1nh gi\u00e1 bao g\u1ed3m \u0111i\u1ec7n gi\u1ea3i \u0111\u1ed3 v\u00e0 ceton huy\u1ebft thanh, glucose huy\u1ebft, v\u00e0 n\u1ebfu c\u00f3 ch\u1ec9 \u0111\u1ecbnh th\u00ec th\u1ef1c hi\u1ec7n \u0111o pH m\u00e1u, lactat, pyruvat, v\u00e0 n\u1ed3ng \u0111\u1ed9 metformin trong m\u00e1u. N\u1ebfu x\u1ea3y ra b\u1ea5t k\u1ef3 th\u1ec3 nhi\u1ec5m toan n\u00e0o, l\u1eadp t\u1ee9c ng\u01b0ng thu\u1ed1c KOMBOGLYZE XR v\u00e0 ti\u1ebfn h\u00e0nh c\u00e1c bi\u1ec7n ph\u00e1p x\u1eed tr\u00ed th\u00edch h\u1ee3p.<\/p>\n<p><em>H\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi sulfonylur\u00ea ho\u1eb7c insulin<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Khi s\u1eed d\u1ee5ng saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi sulfonylur\u00ea ho\u1eb7c v\u1edbi insulin, l\u00e0 c\u00e1c thu\u1ed1c g\u00e2y h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft, t\u1ea7n su\u1ea5t c\u00e1c tr\u01b0\u1eddng h\u1ee3p h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh cao h\u01a1n khi s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c ph\u1ed1i h\u1ee3p v\u1edbi sulfonylur\u00ea ho\u1eb7c v\u1edbi insulin (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd). V\u00ec v\u1eady, c\u1ea7n s\u1eed d\u1ee5ng li\u1ec1u th\u1ea5p c\u00e1c thu\u1ed1c k\u00edch th\u00edch ti\u1ebft insulin ho\u1eb7c insulin \u0111\u1ec3 h\u1ea1n ch\u1ebf t\u1ed1i \u0111a nguy c\u01a1 h\u1ea1 glucose trong m\u00e1u khi s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi KOMBOGLYZE XR (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 C\u00e1ch d\u00f9ng).<\/p>\n<p>Metformin hydrochlorid<\/p>\n<p>T\u00ecnh tr\u1ea1ng h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft kh\u00f4ng x\u1ea3y ra \u1edf c\u00e1c b\u1ec7nh nh\u00e2n d\u00f9ng metformin \u0111\u01a1n \u0111\u1ed9c trong \u0111i\u1ec1u ki\u1ec7n th\u00f4ng th\u01b0\u1eddng, nh\u01b0ng c\u00f3 th\u1ec3 x\u1ea3y ra khi l\u01b0\u1ee3ng calori \u0111\u01b0a v\u00e0o c\u01a1 th\u1ec3 b\u1ecb thi\u1ebfu h\u1ee5t ho\u1eb7c khi t\u1eadp luy\u1ec7n th\u1ec3 l\u1ef1c n\u1eb7ng nh\u01b0ng kh\u00f4ng \u0111\u01b0\u1ee3c b\u00f9 tr\u1eeb b\u1eb1ng vi\u1ec7c b\u1ed5 sung l\u01b0\u1ee3ng calori t\u01b0\u01a1ng \u1ee9ng, ho\u1eb7c khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi c\u00e1c thu\u1ed1c l\u00e0m gi\u1ea3m glucose huy\u1ebft (v\u00ed d\u1ee5 nh\u01b0 sulfonylur\u00ea v\u00e0 insulin), hay ch\u1ea5t c\u1ed3n. \u1ede b\u1ec7nh nh\u00e2n l\u1edbn tu\u1ed5i b\u1ecb suy nh\u01b0\u1ee3c hay suy dinh d\u01b0\u1ee1ng v\u00e0 nh\u1eefng b\u1ec7nh nh\u00e2n suy tuy\u1ebfn th\u01b0\u1ee3ng th\u1eadn ho\u1eb7c suy tuy\u1ebfn y\u00ean ho\u1eb7c ng\u1ed9 \u0111\u1ed9c r\u01b0\u1ee3u \u0111\u1eb7c bi\u1ec7t r\u1ea5t nh\u1ea1y c\u1ea3m v\u1edbi t\u00e1c \u0111\u1ed9ng h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft. T\u00ecnh tr\u1ea1ng h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft c\u00f3 th\u1ec3 kh\u00f3 nh\u1eadn bi\u1ebft tr\u00ean b\u1ec7nh nh\u00e2n l\u1edbn tu\u1ed5i v\u00e0 nh\u1eefng b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng thu\u1ed1c \u1ee9c ch\u1ebf th\u1ee5 th\u1ec3 giao c\u1ea3m beta.<\/p>\n<p><em>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi thu\u1ed1c \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ee9c n\u0103ng th\u1eadn ho\u1eb7c s\u1ef1 ph\u00e2n b\u1ed1 metformin<\/em><\/p>\n<p>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi c\u00e1c thu\u1ed1c n\u00e0y c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng t\u1edbi ch\u1ee9c n\u0103ng th\u1eadn ho\u1eb7c l\u00e0m thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 huy\u1ebft \u0111\u1ed9ng h\u1ecdc, ho\u1eb7c c\u00f3 th\u1ec3 can thi\u1ec7p \u0111\u1ebfn s\u1ef1 ph\u00e2n b\u1ed1 metformin, c\u1ee5 th\u1ec3 nh\u01b0 thu\u1ed1c cationic \u0111\u01b0\u1ee3c \u0111\u00e0o th\u1ea3i qua s\u1ef1 b\u00e0i ti\u1ebft c\u1ee7a \u1ed1ng th\u1eadn (xem ph\u1ea7n T\u01b0\u01a1ng t\u00e1c), do v\u1eady n\u00ean s\u1eed d\u1ee5ng th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi c\u00e1c thu\u1ed1c n\u00e0y.<\/p>\n<p><em>Ch\u1ee5p X-quang c\u00f3 ti\u00eam c\u00e1c ch\u1ea5t c\u1ea3n quang ch\u1ee9a iod<\/em><\/p>\n<p>Ch\u1ee5p X-quang c\u00f3 ti\u00eam c\u00e1c ch\u1ea5t c\u1ea3n quang ch\u1ee9a iod c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn s\u1ef1 bi\u1ebfn \u0111\u1ed5i c\u1ea5p t\u00ednh ch\u1ee9c n\u0103ng th\u1eadn v\u00e0 c\u00f3 li\u00ean quan \u0111\u1ebfn nhi\u1ec5m acid lactic \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng metformin. V\u00ec th\u1ebf, \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n m\u00e0 c\u00f3 d\u1ef1 ki\u1ebfn s\u1ebd th\u1ef1c hi\u1ec7n ch\u1ee5p X-quang th\u00ec n\u00ean ng\u01b0ng d\u00f9ng KOMBOGLYZE t\u1ea1m th\u1eddi tr\u01b0\u1edbc hay ngay th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n v\u00e0 trong 48 gi\u1edd ti\u1ebfp theo sau khi th\u1ef1c hi\u1ec7n, ch\u1ec9 d\u00f9ng thu\u1ed1c tr\u1edf l\u1ea1i sau khi ch\u1ee9c n\u0103ng th\u1eadn \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u1ea1i v\u00e0 x\u00e1c nh\u1eadn l\u00e0 b\u00ecnh th\u01b0\u1eddng.<\/p>\n<p><em>T\u00ecnh tr\u1ea1ng thi\u1ebfu oxy<\/em><\/p>\n<p>Tr\u1ee5y tim m\u1ea1ch (s\u1ed1c), suy tim sung huy\u1ebft c\u1ea5p, nh\u1ed3i m\u00e1u c\u01a1 tim c\u1ea5p v\u00e0 c\u00e1c b\u1ec7nh l\u00fd kh\u00e1c \u0111\u1eb7c tr\u01b0ng b\u1edfi t\u00ecnh tr\u1ea1ng thi\u1ebfu oxy huy\u1ebft, c\u00f3 li\u00ean quan \u0111\u1ebfn nhi\u1ec5m acid lactic v\u00e0 c\u00f3 th\u1ec3 g\u00e2y ra ur\u00ea huy\u1ebft tr\u01b0\u1edbc th\u1eadn. Khi xu\u1ea5t hi\u1ec7n c\u00e1c bi\u1ebfn c\u1ed1 n\u00e0y \u1edf b\u1ec7nh nh\u00e2n \u0111ang \u0111i\u1ec1u tr\u1ecb v\u1edbi KOMBOGLYZE XR, n\u00ean ng\u01b0ng d\u00f9ng thu\u1ed1c ngay l\u1eadp t\u1ee9c.<\/p>\n<p><em>Ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn<\/em><\/p>\n<p>\u0110\u00e3 c\u00f3 c\u00e1c b\u00e1o c\u00e1o ghi nh\u1eadn ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn nghi\u00eam tr\u1ecdng \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin sau khi thu\u1ed1c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng. C\u00e1c ph\u1ea3n \u1ee9ng n\u00e0y bao g\u1ed3m ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7, ph\u00f9 m\u1ea1ch, v\u00e0 c\u00e1c t\u00ecnh tr\u1ea1ng da tr\u00f3c v\u1ea3y. C\u00e1c ph\u1ea3n \u1ee9ng n\u00e0y x\u1ea3y ra trong v\u00f2ng 3 th\u00e1ng \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin, m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p x\u1ea3y ra sau li\u1ec1u \u0111\u1ea7u ti\u00ean. N\u1ebfu nghi ng\u1edd ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn n\u1eb7ng, ng\u01b0ng KOMBOGLYZE XR, \u0111\u00e1nh gi\u00e1 nh\u1eefng nguy\u00ean nh\u00e2n ti\u1ec1m \u1ea9n c\u1ee7a bi\u1ebfn c\u1ed1, v\u00e0 t\u00ecm ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb thay th\u1ebf cho b\u1ec7nh \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p>S\u1eed d\u1ee5ng th\u1eadn tr\u1ecdng cho b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed ph\u00f9 m\u1ea1ch v\u1edbi c\u00e1c ch\u1ea5t \u1ee9c ch\u1ebf dipeptidyl peptidase-4 (DPP4) kh\u00e1c v\u00ec v\u1eabn ch\u01b0a bi\u1ebft c\u00e1c b\u1ec7nh nh\u00e2n n\u00e0y c\u00f3 th\u1ec3 b\u1ecb ph\u00f9 m\u1ea1ch v\u1edbi KOMBOGLYZE XR hay kh\u00f4ng.<\/p>\n<p><em>Suy tim<\/em><\/p>\n<p>Trong nghi\u00ean c\u1ee9u SAVOR, \u0111\u00e3 ghi nh\u1eadn t\u1ef7 l\u1ec7 b\u1ec7nh nh\u00e2n nh\u1eadp vi\u1ec7n do suy tim \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin t\u0103ng so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, m\u1eb7c d\u00f9 m\u1ed1i quan h\u1ec7 nh\u00e2n qu\u1ea3 ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c l\u1eadp. Th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng KOMBOGLYZE XR cho b\u1ec7nh nh\u00e2n c\u00f3 c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 nh\u1eadp vi\u1ec7n do suy tim nh\u01b0 ti\u1ec1n s\u1eed suy tim ho\u1eb7c suy th\u1eadn m\u1ee9c \u0111\u1ed9 trung b\u00ecnh \u0111\u1ebfn n\u1eb7ng. B\u1ec7nh nh\u00e2n n\u00ean \u0111\u01b0\u1ee3c bi\u1ebft nh\u1eefng tri\u1ec7u ch\u1ee9ng suy tim \u0111i\u1ec3n h\u00ecnh v\u00e0 c\u1ea7n b\u00e1o c\u00e1o ngay khi c\u00f3 nh\u1eefng tri\u1ec7u ch\u1ee9ng n\u00e0y (xem ph\u1ea7n Nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng).<\/p>\n<p><em>\u0110au kh\u1edbp<\/em><\/p>\n<p>\u0110au kh\u1edbp, c\u00f3 th\u1ec3 c\u00f3 tr\u01b0\u1eddng h\u1ee3p n\u1eb7ng, \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf nh\u00f3m thu\u1ed1c \u1ee9c ch\u1ebf DPP4 sau khi thu\u1ed1c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng. Tri\u1ec7u ch\u1ee9ng gi\u1ea3m sau khi ng\u01b0ng thu\u1ed1c v\u00e0 \u1edf m\u1ed9t s\u1ed1 b\u1ec7nh nh\u00e2n th\u00ec tri\u1ec7u ch\u1ee9ng t\u00e1i ph\u00e1t khi d\u00f9ng tr\u1edf l\u1ea1i thu\u1ed1c \u0111\u00e3 u\u1ed1ng ho\u1eb7c m\u1ed9t thu\u1ed1c nh\u00f3m \u1ee9c ch\u1ebf DPP4 kh\u00e1c. Tri\u1ec7u ch\u1ee9ng c\u00f3 th\u1ec3 kh\u1edfi ph\u00e1t nhanh sau khi b\u1eaft \u0111\u1ea7u d\u00f9ng thu\u1ed1c ho\u1eb7c sau th\u1eddi gian \u0111i\u1ec1u tr\u1ecb l\u00e2u h\u01a1n. N\u1ebfu xu\u1ea5t hi\u1ec7n \u0111au kh\u1edbp n\u1eb7ng, n\u00ean \u0111\u00e1nh gi\u00e1 vi\u1ec7c ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb cho t\u1eebng b\u1ec7nh nh\u00e2n (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p><em>Bi\u1ebfn ch\u1ee9ng m\u1ea1ch m\u00e1u l\u1edbn<\/em><\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng cho th\u1ea5y b\u1eb1ng ch\u1ee9ng k\u1ebft lu\u1eadn v\u1ec1 vi\u1ec7c gi\u1ea3m nguy c\u01a1 bi\u1ebfn ch\u1ee9ng m\u1ea1ch m\u00e1u l\u1edbn khi d\u00f9ng KOMBOGLYZE XR hay b\u1ea5t c\u1ee9 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng n\u00e0o kh\u00e1c.<\/p>\n<p>Trong nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng SAVOR ng\u1eabu nhi\u00ean, c\u00f3 \u0111\u1ed1i ch\u1ee9ng gi\u1ea3 d\u01b0\u1ee3c, kh\u00f4ng c\u00f3 m\u1ed1i li\u00ean quan gi\u1eefa vi\u1ec7c d\u00f9ng saxagliptin v\u1edbi t\u0103ng nguy c\u01a1 c\u00e1c bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p><em>S\u1eed d\u1ee5ng \u1edf tr\u1ebb em<\/em><\/p>\n<p>Ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a KOMBOGLYZE XR \u1edf tr\u1ebb em d\u01b0\u1edbi 18 tu\u1ed5i. Ngo\u00e0i ra, c\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 t\u00ednh ch\u1ea5t d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a KOMBOGLYZE XR \u1edf tr\u1ebb em ch\u01b0a \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n.<\/p>\n<p><em>S\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi cao tu\u1ed5i<\/em><\/p>\n<p>KOMBOGLYZE XR<\/p>\n<p>B\u1ec7nh nh\u00e2n cao tu\u1ed5i r\u1ea5t c\u00f3 th\u1ec3 b\u1ecb suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn. Do ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh metformin \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn, c\u1ea7n theo d\u00f5i k\u1ef9 ch\u1ee9c n\u0103ng th\u1eadn \u1edf ng\u01b0\u1eddi cao tu\u1ed5i v\u00e0 th\u1eadn tr\u1ecdng s\u1eed d\u1ee5ng KOMBOGLYZE XR khi tu\u1ed5i t\u0103ng d\u1ea7n (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 D\u01b0\u1ee3c l\u00fd).<\/p>\n<p>Saxagliptin<\/p>\n<p>Trong s\u1ed1 16.492 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn ng\u1eabu nhi\u00ean v\u00e0o nghi\u00ean c\u1ee9u SAVOR, c\u00f3 8561 (51,9%) b\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean v\u00e0 2330 (14,1%) b\u1ec7nh nh\u00e2n t\u1eeb 75 tu\u1ed5i tr\u1edf l\u00ean. S\u1ed1 l\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin trong nghi\u00ean c\u1ee9u SAVOR t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean l\u00e0 4290 v\u00e0 t\u1eeb 75 tu\u1ed5i tr\u1edf l\u00ean l\u00e0 1169.<\/p>\n<p>Trong s\u00e1u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 \u0111\u1ed1i ch\u1ee9ng nh\u1eb1m \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 t\u00ednh an to\u00e0n c\u1ee7a saxagliptin tr\u00ean 4148 b\u1ec7nh nh\u00e2n, c\u00f3 634 (15,3%) b\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean v\u00e0 c\u00f3 59 (1,4%) b\u1ec7nh nh\u00e2n t\u1eeb 75 tu\u1ed5i tr\u1edf l\u00ean. Kh\u00f4ng c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t t\u1ed5ng th\u1ec3 v\u1ec1 t\u00ednh an to\u00e0n ho\u1eb7c hi\u1ec7u qu\u1ea3 gi\u1eefa b\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean, b\u1ec7nh nh\u00e2n t\u1eeb 75 tu\u1ed5i tr\u1edf l\u00ean v\u00e0 b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i.<\/p>\n<p>Metformin hydrochlorid<\/p>\n<p>C\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng th\u1ef1c hi\u1ec7n v\u1edbi metformin ch\u01b0a c\u00f3 \u0111\u1ee7 s\u1ed1 l\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n cao tu\u1ed5i gi\u00fap x\u00e1c \u0111\u1ecbnh li\u1ec7u h\u1ecd c\u00f3 \u0111\u00e1p \u1ee9ng kh\u00e1c v\u1edbi c\u00e1c b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i hay kh\u00f4ng, m\u1eb7c d\u00f9 kinh nghi\u1ec7m l\u00e2m s\u00e0ng ch\u01b0a cho th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 \u0111\u00e1p \u1ee9ng gi\u1eefa ng\u01b0\u1eddi cao tu\u1ed5i v\u00e0 ng\u01b0\u1eddi tr\u1ebb tu\u1ed5i. Metformin c\u01a1 b\u1ea3n \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft qua th\u1eadn. Do nguy c\u01a1 x\u1ea3y ra nhi\u1ec5m toan ax\u00edt lactic \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn khi d\u00f9ng metformin cao h\u01a1n, ch\u1ec9 n\u00ean d\u00f9ng KOMBOGLYZE XR \u1edf b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ee9c n\u0103ng th\u1eadn b\u00ecnh th\u01b0\u1eddng. N\u00ean th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng li\u1ec1u kh\u1edfi \u0111\u1ea7u v\u00e0 li\u1ec1u duy tr\u00ec metformin \u1edf b\u1ec7nh nh\u00e2n cao tu\u1ed5i do kh\u1ea3 n\u0103ng b\u1ecb suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn \u1edf c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng n\u00e0y. Vi\u1ec7c \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u n\u00ean d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 ch\u1eb7t ch\u1ebd ch\u1ee9c n\u0103ng th\u1eadn (xem ph\u1ea7n Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, C\u1ea3nh b\u00e1o, v\u00e0 D\u01b0\u1ee3c l\u00fd).<\/p>\n<p><strong>T\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c tr\u00ean ng\u01b0\u1eddi l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/strong><\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u v\u1ec1 t\u00e1c \u0111\u1ed9ng c\u1ee7a KOMBOGLYZE XR hay saxagliptin l\u00ean kh\u1ea3 n\u0103ng l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/p>\n<p>Saxagliptin ho\u1eb7c metformin c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng kh\u00f4ng \u0111\u00e1ng k\u1ec3 \u0111\u1ebfn kh\u1ea3 n\u0103ng l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c. C\u1ea7n l\u01b0u \u00fd r\u1eb1ng ch\u00f3ng m\u1eb7t \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn trong c\u00e1c nghi\u00ean c\u1ee9u v\u1edbi saxagliptin.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h3><span class=\"ez-toc-section\" id=\"45-su-dung-cho-phu-nu-co-thai-va-cho-con-bu\"><\/span>4.5 S\u1eed d\u1ee5ng cho ph\u1ee5 n\u1eef c\u00f3 thai v\u00e0 cho con b\u00fa:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>X\u1ebfp h\u1ea1ng c\u1ea3nh b\u00e1o<\/em><\/p>\n<p>AU TGA pregnancy category: C<\/p>\n<p>US FDA pregnancy category: B<\/p>\n<p><em>Th\u1eddi k\u1ef3 mang thai:<\/em><\/p>\n<p>Ph\u1ee5 n\u1eef c\u00f3 thai &#8211; nh\u00f3m B<\/p>\n<p>Ch\u01b0a c\u00f3 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c nghi\u00ean c\u1ee9u c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng KOMBOGLYZE XR hay c\u00e1c th\u00e0nh ph\u1ea7n ri\u00eang l\u1ebb c\u1ee7a thu\u1ed1c tr\u00ean ph\u1ee5 n\u1eef \u0111ang mang thai. Do c\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 sinh s\u1ea3n tr\u00ean \u0111\u1ed9ng v\u1eadt kh\u00f4ng th\u1ec3 lu\u00f4n lu\u00f4n d\u00f9ng \u0111\u1ec3 ti\u00ean \u0111o\u00e1n \u0111\u00e1p \u1ee9ng x\u1ea3y ra tr\u00ean ng\u01b0\u1eddi, kh\u00f4ng n\u00ean s\u1eed d\u1ee5ng KOMBOGLYZE XR c\u0169ng nh\u01b0 c\u00e1c thu\u1ed1c tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng kh\u00e1c trong khi \u0111ang mang thai tr\u1eeb khi th\u1eadt s\u1ef1 c\u1ea7n thi\u1ebft.<\/p>\n<p>S\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 metformin cho chu\u1ed9t c\u1ed1ng v\u00e0 th\u1ecf \u0111ang mang thai trong su\u1ed1t giai \u0111o\u1ea1n th\u00e0nh l\u1eadp c\u01a1 quan, kh\u00f4ng ph\u00e1t hi\u1ec7n g\u00e2y ch\u1ebft ph\u00f4i thai hay qu\u00e1i thai khi kh\u1ea3o s\u00e1t \u1edf li\u1ec1u m\u00e0 n\u1ed3ng \u0111\u1ed9 to\u00e0n th\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c (AUC) \u1edf chu\u1ed9t c\u1ed1ng l\u00ean \u0111\u1ebfn 100 v\u00e0 g\u1ea5p 10 l\u1ea7n li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o \u1edf ng\u01b0\u1eddi (MRHD; saxagliptin 5 mg v\u00e0 metformin 2000 mg); n\u1ed3ng \u0111\u1ed9 to\u00e0n th\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c \u1edf th\u1ecf l\u00ean \u0111\u1ebfn 249 v\u00e0 g\u1ea5p 1,1 l\u1ea7n li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o \u1edf ng\u01b0\u1eddi. Tr\u00ean chu\u1ed9t c\u1ed1ng, s\u1ef1 ti\u1ebfn tri\u1ec3n c\u1ee7a \u0111\u1ed9c t\u00ednh th\u1ee9 y\u1ebfu \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u1edf m\u1ee9c t\u1ef7 l\u1ec7 t\u0103ng c\u1ee7a \u0111\u01b0\u1eddng cong; \u0111\u1ed9c t\u00ednh thai k\u1ef3 \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u1edf m\u1ee9c t\u1ef7 l\u1ec7 gi\u1ea3m tr\u1ecdng l\u01b0\u1ee3ng t\u1eeb 11% \u0111\u1ebfn 17% trong ti\u1ebfn tr\u00ecnh nghi\u00ean c\u1ee9u v\u00e0 li\u00ean quan \u0111\u1ebfn s\u1ef1 gi\u1ea3m th\u1ef1c ph\u1ea9m trong thai k\u1ef3. Tr\u00ean th\u1ecf, m\u1ed9t ph\u00e2n nh\u00f3m c\u00e1c th\u1ecf m\u1eb9 (12 con trong s\u1ed1 30 con), dung n\u1ea1p k\u00e9m d\u1ea1ng thu\u1ed1c ph\u1ed1i h\u1ee3p, k\u1ebft qu\u1ea3 l\u00e0 d\u1eabn \u0111\u1ebfn t\u1eed vong, h\u1ea5p h\u1ed1i ho\u1eb7c s\u1ea9y thai. Tuy nhi\u00ean, trong s\u1ed1 c\u00e1c th\u1ecf m\u1eb9 s\u1ed1ng s\u00f3t c\u1ee7a l\u1ee9a \u0111\u1ebb \u0111\u00e1nh gi\u00e1, \u0111\u1ed9c t\u00ednh thai k\u1ef3 \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u1edf m\u1ee9c bi\u00ean \u0111\u1ed9 gi\u1ea3m c\u1ee7a tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 t\u1eeb ng\u00e0y 21 \u0111\u1ebfn ng\u00e0y 29 c\u1ee7a thai k\u1ef3. V\u00e0 \u0111\u1ed9c t\u00ednh ti\u1ebfn tri\u1ec3n \u1edf c\u00e1c l\u1ee9a \u0111\u1ebb n\u00e0y \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u1edf m\u1ee9c gi\u1ea3m tr\u1ecdng l\u01b0\u1ee3ng thai nhi 7% v\u00e0 m\u1ed9t t\u1ef7 l\u1ec7 th\u1ea5p ch\u1eadm c\u1ed1t h\u00f3a \u1edf m\u00f3ng c\u1ee7a thai nhi.<\/p>\n<p>Saxagliptin<\/p>\n<p>Saxagliptin kh\u00f4ng g\u00e2y qu\u00e1i thai \u1edf b\u1ea5t k\u1ef3 li\u1ec1u l\u01b0\u1ee3ng kh\u1ea3o s\u00e1t n\u00e0o tr\u00ean chu\u1ed9t c\u1ed1ng v\u00e0 th\u1ecf \u0111ang mang thai trong su\u1ed1t qu\u00e1 tr\u00ecnh h\u00ecnh th\u00e0nh c\u01a1 quan. Tr\u00ean chu\u1ed9t c\u1ed1ng, saxagliptin \u1edf li\u1ec1u 240 mg\/kg (x\u1ea5p x\u1ec9 1503 l\u1ea7n n\u1ed3ng \u0111\u1ed9 saxagliptin \u1edf ng\u01b0\u1eddi v\u00e0 66 l\u1ea7n n\u1ed3ng \u0111\u1ed9 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh \u1edf ng\u01b0\u1eddi khi s\u1eed d\u1ee5ng li\u1ec1u t\u1ed1i \u0111a 5 mg) \u0111\u00e3 ghi nh\u1eadn c\u00f3 s\u1ef1 c\u1ed1t h\u00f3a kh\u00f4ng ho\u00e0n to\u00e0n x\u01b0\u01a1ng ch\u1eadu (m\u1ed9t th\u1ec3 ch\u1eadm ph\u00e1t tri\u1ec3n). \u0110\u1ed9c t\u00ednh thai k\u1ef3 v\u00e0 gi\u1ea3m tr\u1ecdng l\u01b0\u1ee3ng b\u00e0o thai \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf li\u1ec1u cao g\u1ea5p 7986 l\u1ea7n (saxagliptin) v\u00e0 cao g\u1ea5p 328 l\u1ea7n (ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh) so v\u1edbi li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o tr\u00ean ng\u01b0\u1eddi. Tr\u00ean th\u1ecf, ch\u1ec9 ghi nh\u1eadn \u0111\u01b0\u1ee3c c\u00e1c thay \u0111\u1ed5i nh\u1ecf c\u1ee7a b\u1ed9 x\u01b0\u01a1ng \u1edf li\u1ec1u g\u00e2y \u0111\u1ed9c t\u00ednh tr\u00ean th\u1ecf m\u1eb9 200 mg\/kg (x\u1ea5p x\u1ec9 g\u1ea5p 1432 l\u1ea7n n\u1ed3ng \u0111\u1ed9 saxagliptin v\u00e0 cao g\u1ea5p 992 l\u1ea7n n\u1ed3ng \u0111\u1ed9 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh khi s\u1eed d\u1ee5ng theo li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o tr\u00ean ng\u01b0\u1eddi).<\/p>\n<p>Khi s\u1eed d\u1ee5ng saxagliptin tr\u00ean chu\u1ed9t c\u1ed1ng c\u00e1i t\u1eeb ng\u00e0y th\u1ee9 6 trong th\u1eddi gian mang thai cho \u0111\u1ebfn ng\u00e0y 20 trong th\u1eddi k\u1ef3 cho b\u00fa, tr\u1ecdng l\u01b0\u1ee3ng c\u1ee7a chu\u1ed9t con (\u0111\u1ef1c v\u00e0 c\u00e1i) ch\u1ec9 gi\u1ea3m \u1edf li\u1ec1u g\u00e2y \u0111\u1ed9c t\u00ednh cho chu\u1ed9t m\u1eb9 (n\u1ed3ng \u0111\u1ed9 saxagliptin cao g\u1ea5p \u22651629 v\u00e0 n\u1ed3ng \u0111\u1ed9 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh cao g\u1ea5p 53 l\u1ea7n so v\u1edbi li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o tr\u00ean ng\u01b0\u1eddi). Kh\u00f4ng c\u00f3 \u0111\u1ed9c t\u00ednh tr\u00ean ch\u1ee9c n\u0103ng v\u00e0 h\u00e0nh vi x\u1ea3y ra tr\u00ean chu\u1ed9t con s\u1eed d\u1ee5ng saxagliptin \u1edf b\u1ea5t k\u1ef3 li\u1ec1u n\u00e0o.<\/p>\n<p>Saxagliptin qua nhau thai v\u00e0 v\u00e0o b\u00e0o thai theo li\u1ec1u s\u1eed d\u1ee5ng tr\u00ean chu\u1ed9t m\u1eb9 \u0111ang mang thai.<\/p>\n<p>Metformin hydroclorid<\/p>\n<p>Metformin kh\u00f4ng g\u00e2y qu\u00e1i thai tr\u00ean chu\u1ed9t c\u1ed1ng v\u00e0 th\u1ecf v\u1edbi li\u1ec1u l\u00ean \u0111\u1ebfn 600 mg\/kg\/ng\u00e0y. \u0110i\u1ec1u n\u00e0y t\u01b0\u01a1ng \u1ee9ng v\u1edbi n\u1ed3ng \u0111\u1ed9 trong c\u01a1 th\u1ec3 g\u1ea5p 2 \u0111\u1ebfn 6 l\u1ea7n li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng h\u00e0ng ng\u00e0y \u1edf ng\u01b0\u1eddi (2000 mg) d\u1ef1a tr\u00ean di\u1ec7n t\u00edch b\u1ec1 m\u1eb7t c\u01a1 th\u1ec3 so s\u00e1nh v\u1edbi chu\u1ed9t c\u1ed1ng v\u00e0 th\u1ecf. Metformin qua \u0111\u01b0\u1ee3c h\u00e0ng r\u00e0o nhau thai v\u00e0 v\u00e0o b\u00e0o thai.<\/p>\n<p><em>Th\u1eddi k\u1ef3 cho con b\u00fa:<\/em><\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u th\u1ef1c hi\u1ec7n tr\u00ean \u0111\u1ed9ng v\u1eadt \u0111ang cho con b\u00fa s\u1eed d\u1ee5ng d\u1ea1ng ph\u1ed1i h\u1ee3p c\u1ee7a KOMBOGLYZE XR. Trong c\u00e1c nghi\u00ean c\u1ee9u th\u1ef1c hi\u1ec7n tr\u00ean t\u1eebng th\u00e0nh ph\u1ea7n thu\u1ed1c, c\u1ea3 saxagliptin v\u00e0 metformin \u0111\u1ec1u \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft trong s\u1eefa \u1edf chu\u1ed9t \u0111ang cho con b\u00fa. Ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c saxagliptin ho\u1eb7c metformin c\u00f3 b\u00e0i ti\u1ebft trong s\u1eefa m\u1eb9 \u1edf ng\u01b0\u1eddi hay kh\u00f4ng. Do r\u1ea5t nhi\u1ec1u thu\u1ed1c b\u00e0i ti\u1ebft trong s\u1eefa m\u1eb9, c\u1ea7n th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng KOMBOGLYZE XR \u1edf ph\u1ee5 n\u1eef \u0111ang cho con b\u00fa.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"46-tac-dung-khong-mong-muon-adr\"><\/span>4.6 T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (ADR):<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>Kinh nghi\u1ec7m t\u1eeb c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng<\/em><\/p>\n<p>Do c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh d\u01b0\u1edbi nh\u1eefng \u0111i\u1ec1u ki\u1ec7n kh\u00e1c nhau n\u00ean t\u1ef7 l\u1ec7 c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n ghi nh\u1eadn \u0111\u01b0\u1ee3c trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng tr\u00ean 1 thu\u1ed1c kh\u00f4ng th\u1ec3 d\u00f9ng \u0111\u1ec3 so s\u00e1nh tr\u1ef1c ti\u1ebfp v\u1edbi t\u1ef7 l\u1ec7 xu\u1ea5t hi\u1ec7n trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u1ee7a m\u1ed9t thu\u1ed1c kh\u00e1c, v\u00e0 v\u00ec th\u1ebf kh\u00f4ng ph\u1ea3n \u00e1nh \u0111\u01b0\u1ee3c t\u1ef7 l\u1ec7 xu\u1ea5t hi\u1ec7n trong th\u1ef1c t\u1ebf \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>Trong nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 \u0111\u1ed1i ch\u1ee9ng, h\u01a1n 17.000 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin.<\/p>\n<p><em>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n c\u00f3 li\u00ean quan \u0111\u1ebfn saxagliptin trong nghi\u00ean c\u1ee9u SAVOR<\/em><\/p>\n<p>Nghi\u00ean c\u1ee9u SAVOR g\u1ed3m 8240 b\u1ec7nh nh\u00e2n d\u00f9ng saxagliptin 5 mg ho\u1eb7c 2,5 mg 1 l\u1ea7n\/ng\u00e0y v\u00e0 8173 b\u1ec7nh nh\u00e2n d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Th\u1eddi gian trung b\u00ecnh ti\u1ebfp x\u00fac v\u1edbi saxagliptin b\u1ea5t k\u1ec3 c\u00f3 gi\u00e1n \u0111o\u1ea1n hay kh\u00f4ng l\u00e0 1,8 n\u0103m. T\u1ed5ng s\u1ed1 3698 b\u1ec7nh nh\u00e2n (45%) \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin t\u1eeb 2 \u0111\u1ebfn 3 n\u0103m.<\/p>\n<p>T\u1ef7 l\u1ec7 chung c\u00e1c bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng saxagliptin trong nghi\u00ean c\u1ee9u n\u00e0y t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c (72,5% so v\u1edbi 72,2%). Ng\u01b0ng tr\u1ecb li\u1ec7u do bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau \u1edf 2 nh\u00f3m \u0111i\u1ec1u tr\u1ecb (4,9% \u1edf nh\u00f3m d\u00f9ng saxagliptin v\u00e0 5,0% \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c). Bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd nghi\u00eam tr\u1ecdng t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau \u1edf 2 nh\u00f3m \u0111i\u1ec1u tr\u1ecb (24,2% \u1edf nh\u00f3m d\u00f9ng saxagliptin v\u00e0 23,7% \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c).<\/p>\n<p>An to\u00e0n tim m\u1ea1ch c\u1ee7a saxagliptin \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong nghi\u00ean c\u1ee9u SAVOR, x\u00e1c \u0111\u1ecbnh saxagliptin kh\u00f4ng l\u00e0m t\u0103ng nguy c\u01a1 tim m\u1ea1ch (t\u1eed vong do tim m\u1ea1ch, nh\u1ed3i m\u00e1u c\u01a1 tim kh\u00f4ng t\u1eed vong, ho\u1eb7c \u0111\u1ed9t qu\u1ef5 do thi\u1ebfu m\u00e1u kh\u00f4ng t\u1eed vong) \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c khi ph\u1ed1i h\u1ee3p v\u1edbi li\u1ec7u ph\u00e1p n\u1ec1n hi\u1ec7n t\u1ea1i (t\u1ef7 s\u1ed1 nguy c\u01a1 [HR]: 1,00; kho\u1ea3ng tin c\u1eady [CI] 95%: 0,89, 1,12; P&lt;0,001 cho ph\u00e2n t\u00edch kh\u00f4ng k\u00e9m h\u01a1n) (xem ph\u1ea7n Nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng).<\/p>\n<p>Trong nghi\u00ean c\u1ee9u SAVOR, t\u1ef7 l\u1ec7 bi\u1ebfn c\u1ed1 vi\u00eam t\u1ee5y x\u00e1c \u0111\u1ecbnh sau khi hi\u1ec7u ch\u1ec9nh l\u00e0 0,3% \u1edf c\u1ea3 2 nh\u00f3m d\u00f9ng saxagliptin v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c trong d\u00e2n s\u1ed1 d\u1ef1 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb (ITT).<\/p>\n<p>T\u1ef7 l\u1ec7 ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn l\u00e0 1,1% \u1edf c\u1ea3 2 nh\u00f3m d\u00f9ng saxagliptin v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p><em>H\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft<\/em><\/p>\n<p>Trong nghi\u00ean c\u1ee9u SAVOR, t\u1ef7 l\u1ec7 chung bi\u1ebfn c\u1ed1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 17,1% \u1edf nh\u00f3m d\u00f9ng saxagliptin v\u00e0 14,8% \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>T\u1ef7 l\u1ec7 b\u1ec7nh nh\u00e2n g\u1eb7p bi\u1ebfn c\u1ed1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft nghi\u00eam tr\u1ecdng (\u0111\u1ecbnh ngh\u0129a l\u00e0 c\u1ea7n s\u1ef1 tr\u1ee3 gi\u00fap c\u1ee7a ng\u01b0\u1eddi kh\u00e1c) cao h\u01a1n \u1edf nh\u00f3m d\u00f9ng saxagliptin so v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c (2,1% so v\u1edbi 1,6%).<\/p>\n<p>T\u0103ng nguy c\u01a1 bi\u1ebfn c\u1ed1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft chung v\u00e0 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft n\u1eb7ng \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf nh\u00f3m d\u00f9ng saxagliptin x\u1ea3y ra ch\u1ee7 y\u1ebfu \u1edf nh\u00f3m \u0111\u00e3 d\u00f9ng 1 thu\u1ed1c sulfonylur\u00ea ban \u0111\u1ea7u, kh\u00f4ng x\u1ea3y ra \u1edf nh\u00f3m d\u00f9ng insulin hay metformin \u0111\u01a1n tr\u1ecb li\u1ec7u ban \u0111\u1ea7u.<\/p>\n<p>Nguy c\u01a1 gia t\u0103ng bi\u1ebfn c\u1ed1 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft chung v\u00e0 h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft n\u1eb7ng ch\u1ee7 y\u1ebfu \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng c\u00f3 HbA1C &lt; 7% t\u1ea1i th\u1eddi \u0111i\u1ec3m ban \u0111\u1ea7u.<\/p>\n<p><em>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u v\u00e0 v\u1edbi li\u1ec7u ph\u00e1p ph\u1ed1i h\u1ee3p b\u1ed5 sung trong nh\u1eefng nghi\u00ean c\u1ee9u ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft<\/em><\/p>\n<p>Metformin hydroclorid<\/p>\n<p>Trong th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u01a1n tr\u1ecb li\u1ec7u c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c c\u1ee7a metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i, ti\u00eau ch\u1ea3y v\u00e0 bu\u1ed3n n\u00f4n\/n\u00f4n \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o trong &gt;5% b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng metformin v\u00e0 ph\u1ed5 bi\u1ebfn h\u01a1n so v\u1edbi b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi gi\u1ea3 d\u01b0\u1ee3c (ti\u00eau ch\u1ea3y g\u1eb7p \u1edf 9,6% d\u00f9ng metformin so v\u1edbi 2,6% d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c; bu\u1ed3n n\u00f4n\/n\u00f4n g\u1eb7p \u1edf 6,5% b\u1ec7nh nh\u00e2n d\u00f9ng metformin so v\u1edbi 1,5% d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c). Ti\u00eau ch\u1ea3y d\u1eabn \u0111\u1ebfn ng\u01b0ng \u0111i\u1ec1u tr\u1ecb g\u1eb7p \u1edf 0,6% b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i.<\/p>\n<p>Saxagliptin<\/p>\n<p>Hai th\u1eed nghi\u1ec7m \u0111\u01a1n tr\u1ecb li\u1ec7u c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, k\u00e9o d\u00e0i trong 24 tu\u1ea7n trong \u0111\u00f3 c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin 2,5 mg m\u1ed7i ng\u00e0y, saxagliptin 5 mg m\u1ed7i ng\u00e0y v\u00e0 gi\u1ea3 d\u01b0\u1ee3c. 3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c kh\u00e1c k\u00e9o d\u00e0i trong 24 tu\u1ea7n, s\u1eed d\u1ee5ng ch\u1ebf \u0111\u1ed9 tr\u1ecb li\u1ec7u ph\u1ed1i h\u1ee3p b\u1ed5 sung: 1 th\u1eed nghi\u1ec7m tr\u00ean metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, 1 th\u1eed nghi\u1ec7m tr\u00ean 1 thu\u1ed1c nh\u00f3m thiazolidinedione (pioglitazone hay rosiglitazone), v\u00e0 1 th\u1eed nghi\u1ec7m v\u1edbi glyburide. Trong 3 th\u1eed nghi\u1ec7m n\u00e0y, c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean v\u00e0o nh\u00f3m tr\u1ecb li\u1ec7u ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi saxagliptin 2,5 mg m\u1ed7i ng\u00e0y, saxagliptin 5 mg m\u1ed7i ng\u00e0y, ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c (placebo). M\u1ed9t nh\u00f3m kh\u00e1c \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng saxagliptin 10 mg c\u0169ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong 1 th\u1eed nghi\u1ec7m \u0111\u01a1n tr\u1ecb li\u1ec7u v\u00e0 tr\u1ecb li\u1ec7u ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi. Li\u1ec1u saxagliptin 10 mg kh\u00f4ng ph\u1ea3i li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/p>\n<p>Trong ph\u00e2n t\u00edch g\u1ed9p tr\u00ean d\u1eef li\u1ec7u trong 24 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb (kh\u00f4ng li\u00ean quan v\u1edbi m\u1ee9c gi\u1ea3m glucose huy\u1ebft) t\u1eeb hai th\u1eed nghi\u1ec7m \u0111\u01a1n tr\u1ecb li\u1ec7u, th\u1eed nghi\u1ec7m ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, th\u1eed nghi\u1ec7m ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi thiazolidinedione (TZD) v\u00e0 th\u1eed nghi\u1ec7m ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi glyburide, t\u1ef7 l\u1ec7 t\u1ed5ng th\u1ec3 c\u00e1c bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd x\u1ea3y ra \u1edf c\u00e1c b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 2,5 mg v\u00e0 5 mg l\u00e0 t\u01b0\u01a1ng t\u1ef1 v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c (t\u01b0\u01a1ng \u1ee9ng l\u00e0 72% v\u00e0 72,2% so v\u1edbi 70,6%). Ng\u01b0ng tr\u1ecb li\u1ec7u do bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd x\u1ea3y ra tr\u00ean 2,2% b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 2,5 mg, 3,3% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 5 mg v\u00e0 1,8% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c. Bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd th\u01b0\u1eddng g\u1eb7p nh\u1ea5t (\u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean t\u1ed1i thi\u1ec3u 2 b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 2,5 mg ho\u1eb7c t\u1ed1i thi\u1ec3u 2 b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 5 mg) li\u00ean quan \u0111\u1ebfn vi\u1ec7c ph\u1ea3i ng\u01b0ng tr\u1ecb li\u1ec7u s\u1edbm bao g\u1ed3m gi\u1ea3m b\u1ea1ch c\u1ea7u lympho (0,1% v\u00e0 0,5% so v\u1edbi 0% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c), n\u1ed5i m\u1ea9n (0,2% v\u00e0 0,3% so v\u1edbi 0,3%), t\u0103ng creatinine trong m\u00e1u (0,3% v\u00e0 0% so v\u1edbi 0%), t\u0103ng creatine phosphokinase trong m\u00e1u (0,1% v\u00e0 0,2% so v\u1edbi 0%). B\u1ea3ng 11 tr\u00ecnh b\u00e0y c\u00e1c ph\u1ea3n \u1ee9ng kh\u00f4ng mong mu\u1ed1n trong ph\u00e2n t\u00edch n\u00e0y (kh\u00f4ng x\u00e9t \u0111\u1ebfn quan h\u1ec7 nh\u00e2n qu\u1ea3 theo \u0111\u00e1nh gi\u00e1 c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean) x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u22655% \u1edf b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin 5 mg, v\u00e0 xu\u1ea5t hi\u1ec7n v\u1edbi m\u1ee9c \u0111\u1ed9 th\u01b0\u1eddng xuy\u00ean h\u01a1n so v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>&#8211; xem B\u1ea3ng 11.C\u00e1c ph\u1ea3n \u1ee9ng kh\u00f4ng mong mu\u1ed1n trong c\u00e1c th\u1eed nghi\u1ec7m c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o v\u1edbi t\u1ef7 l\u1ec7 xu\u1ea5t hi\u1ec7n \u2265 5% \u1edf c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Saxagliptin 5mg v\u00e0 xu\u1ea5t hi\u1ec7n th\u01b0\u1eddng xuy\u00ean h\u01a1n so v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\">&#8211;<\/td>\n<td colspan=\"2\"><strong>S\u1ed1 b\u1ec7nh nh\u00e2n (%)<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Saxagliptin 5mg N=882<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c N=799<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Nhi\u1ec5m tr\u00f9ng \u0111\u01b0\u1eddng h\u00f4 h\u1ea5p tr\u00ean<\/strong><\/td>\n<td>68 (7.7)<\/td>\n<td>61 (7.6)<\/td>\n<\/tr>\n<tr>\n<td><strong>Nhi\u1ec5m tr\u00f9ng \u0111\u01b0\u1eddng ti\u1ec3u<\/strong><\/td>\n<td>60 (6.8)<\/td>\n<td>49 (6.1)<\/td>\n<\/tr>\n<tr>\n<td><strong>Nh\u1ee9c \u0111\u1ea7u<\/strong><\/td>\n<td>57 (6.5)<\/td>\n<td>47 (5.9)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">*5 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, k\u1ec3 c\u1ea3 2 th\u1eed nghi\u1ec7m \u0111\u01a1n tr\u1ecb li\u1ec7u v\u00e0 1 th\u1eed nghi\u1ec7m ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi 1 trong c\u00e1c thu\u1ed1c sau: Metformin, Thiazolidinedione hay Glyburide. B\u1ea3ng n\u00e0y tr\u00ecnh b\u00e0y s\u1ed1 li\u1ec7u trong 24 tu\u1ea7n kh\u00f4ng li\u00ean quan \u0111\u1ebfn c\u1ea5p c\u1ee9u h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u1ede c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin 2,5 mg, nh\u1ee9c \u0111\u1ea7u (6,5%) l\u00e0 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n duy nh\u1ea5t x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u22655% v\u00e0 x\u1ea3y ra ph\u1ed5 bi\u1ebfn h\u01a1n so v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>Trong ph\u00e2n t\u00edch g\u1ed9p n\u00e0y, c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u22652% \u1edf b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng saxagliptin 2,5 mg hay saxagliptin 5 mg v\u00e0 c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u22651% (th\u01b0\u1eddng xuy\u00ean h\u01a1n so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c) bao g\u1ed3m: vi\u00eam xoang (2,9% v\u00e0 2,6% so v\u1edbi 1,6% \u1edf gi\u1ea3 d\u01b0\u1ee3c), \u0111au b\u1ee5ng (2,4% v\u00e0 1,7% so v\u1edbi 0,5%), vi\u00eam d\u1ea1 d\u00e0y-ru\u1ed9t (1,9% v\u00e0 2,3% so v\u1edbi 0,9%), v\u00e0 n\u00f4n m\u1eeda (2,2% v\u00e0 2,3% so v\u1edbi 1,3%).<\/p>\n<p>T\u1ef7 l\u1ec7 g\u00e3y x\u01b0\u01a1ng l\u00e0 1,0 trong 100 b\u1ec7nh nh\u00e2n-n\u0103m (patient-year) \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin (ph\u00e2n t\u00edch g\u1ed9p tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng li\u1ec1u 2,5 mg, 5 mg, v\u00e0 10 mg) so v\u1edbi 0,6 trong 100 b\u1ec7nh nh\u00e2n-n\u0103m \u0111\u1ed1i v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Li\u1ec1u saxagliptin 10 mg kh\u00f4ng ph\u1ea3i li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. T\u1ea7n su\u1ea5t c\u00e1c bi\u1ebfn c\u1ed1 g\u00e3y x\u01b0\u01a1ng \u1edf c\u00e1c b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin kh\u00f4ng t\u0103ng theo th\u1eddi gian. Nguy\u00ean nh\u00e2n g\u00e3y x\u01b0\u01a1ng v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u00e0 c\u00e1c th\u1eed nghi\u1ec7m ti\u1ec1n l\u00e2m s\u00e0ng c\u0169ng kh\u00f4ng cho th\u1ea5y \u1ea3nh h\u01b0\u1edfng c\u1ee7a saxagliptin tr\u00ean x\u01b0\u01a1ng.<\/p>\n<p>M\u1ed9t tr\u01b0\u1eddng h\u1ee3p b\u1ecb gi\u1ea3m ti\u1ec3u c\u1ea7u, ph\u00f9 h\u1ee3p v\u1edbi ch\u1ea9n \u0111o\u00e1n xu\u1ea5t huy\u1ebft do gi\u1ea3m ti\u1ec3u c\u1ea7u t\u1ef1 ph\u00e1t \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng. Ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c m\u1ed1i li\u00ean h\u1ec7 gi\u1eefa tr\u01b0\u1eddng h\u1ee3p gi\u1ea3m ti\u1ec3u c\u1ea7u n\u00e0y v\u1edbi saxagliptin.<\/p>\n<p><em>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n khi d\u00f9ng \u0111\u1ed3ng th\u1eddi v\u1edbi insulin<\/em><\/p>\n<p>Trong th\u1eed nghi\u1ec7m ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi insulin (xem ph\u1ea7n Nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng), t\u1ef7 l\u1ec7 c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n, bao g\u1ed3m t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n nghi\u00eam tr\u1ecdng v\u00e0 ng\u01b0ng \u0111i\u1ec1u tr\u1ecb do t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n, th\u00ec t\u01b0\u01a1ng t\u1ef1 gi\u1eefa nh\u00f3m s\u1eed d\u1ee5ng saxagliptin v\u00e0 gi\u1ea3 d\u01b0\u1ee3c, ngo\u1ea1i tr\u1eeb t\u00e1c d\u1ee5ng g\u00e2y h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh (xem ph\u1ea7n T\u00e1c d\u1ee5ng ngo\u1ea1i \u00fd).<\/p>\n<p><em>C\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n li\u00ean quan \u0111\u1ebfn saxagliptin khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, trong \u0111i\u1ec1u tr\u1ecb kh\u1edfi \u0111\u1ea7u cho c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2<\/em><\/p>\n<p>B\u1ea3ng 12 tr\u00ecnh b\u00e0y s\u1ed1 li\u1ec7u c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (kh\u00f4ng x\u00e9t \u0111\u1ebfn quan h\u1ec7 nh\u00e2n qu\u1ea3 theo \u0111\u00e1nh gi\u00e1 c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean) ghi nh\u1eadn v\u1edbi t\u1ef7 l\u1ec7 \u22655% \u1edf c\u00e1c b\u1ec7nh nh\u00e2n tham gia v\u00e0o th\u1eed nghi\u1ec7m c\u00f3 \u0111\u1ed1i ch\u1ee9ng, ph\u1ed1i h\u1ee3p b\u1ed5 sung saxagliptin v\u1edbi metformin trong 24 tu\u1ea7n cho b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>&#8211; xem B\u1ea3ng 12. \u0110i\u1ec1u tr\u1ecb kh\u1edfi \u0111\u1ea7u ph\u1ed1i h\u1ee3p gi\u1eefa Saxagliptin v\u00e0 Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u1edf c\u00e1c b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb: c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u2265 5% \u1edf c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p Saxagliptin 5mg + Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi (v\u00e0 x\u1ea3y ra th\u01b0\u1eddng xuy\u00ean h\u01a1n so v\u1edbi b\u1ec7nh nh\u00e2n ch\u1ec9 s\u1eed d\u1ee5ng Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi)<\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\">&#8211;<\/td>\n<td colspan=\"2\"><strong>S\u1ed1 b\u1ec7nh nh\u00e2n (%)<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Saxagliptin 5mg + Metformin* N=320<\/strong><\/td>\n<td><strong>Placebo+Metformin* N=328<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Nh\u1ee9c \u0111\u1ea7u<\/strong><\/td>\n<td>24 (7.5)<\/td>\n<td>17 (5.2)<\/td>\n<\/tr>\n<tr>\n<td><strong>Vi\u00eam m\u0169i &#8211; h\u1ea7u<\/strong><\/td>\n<td>22 (6.9)<\/td>\n<td>13 (4.0)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">*Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u0111\u01b0\u1ee3c kh\u1edfi \u0111\u1ea7u b\u1eb1ng li\u1ec1u 500mg m\u1ed7i ng\u00e0y v\u00e0 \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ebfn li\u1ec1u t\u1ed1i \u0111a 2000mg m\u1ed7i ng\u00e0y.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u1ede c\u00e1c b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, g\u1ed3m nh\u00f3m c\u00f3 b\u1ed5 sung saxagliptin v\u00e0o li\u1ec7u tr\u00ecnh \u0111i\u1ec1u tr\u1ecb metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi ho\u1eb7c \u0111i\u1ec1u tr\u1ecb \u0111\u1ed3ng th\u1eddi c\u1ea3 saxagliptin v\u00e0 metformin tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3, tri\u1ec7u ch\u1ee9ng ti\u00eau ch\u1ea3y l\u00e0 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n duy nh\u1ea5t tr\u00ean d\u1ea1 d\u00e0y-ru\u1ed9t x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 \u22655% trong b\u1ea5t c\u1ee9 nh\u00f3m \u0111i\u1ec1u tr\u1ecb trong c\u1ea3 hai nghi\u00ean c\u1ee9u. Trong th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi c\u00f3 b\u1ed5 sung saxagliptin, t\u1ef7 l\u1ec7 ti\u00eau ch\u1ea3y l\u00e0 9,9% tr\u00ean nh\u00f3m saxagliptin 2,5 mg; 5,8% tr\u00ean nh\u00f3m saxagliptin 5 mg v\u00e0 11,2% tr\u00ean nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c. Khi ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u1edf b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3, t\u1ef7 l\u1ec7 ti\u00eau ch\u1ea3y l\u00e0 6,9% trong nh\u00f3m d\u00f9ng saxagliptin 5 mg + metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi v\u00e0 7,3% trong nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c + metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p><em>T\u1ee5t \u0111\u01b0\u1eddng huy\u1ebft<\/em><\/p>\n<p>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n g\u00e2y h\u1ea1 glucose m\u00e1u \u0111\u01b0\u1ee3c thu th\u1eadp qua t\u1ea5t c\u1ea3 c\u00e1c b\u00e1o c\u00e1o v\u1ec1 h\u1ea1 glucose m\u00e1u. M\u1ed9t s\u1ed1 b\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111o ch\u1ec9 s\u1ed1 glucose m\u00e1u c\u00f9ng l\u00fac ho\u1eb7c ch\u1ec9 s\u1ed1 \u0111o \u0111\u01b0\u1ee3c v\u1eabn trong gi\u1edbi h\u1ea1n b\u00ecnh th\u01b0\u1eddng. V\u00ec v\u1eady, kh\u00f4ng th\u1ec3 x\u00e1c \u0111\u1ecbnh r\u00f5 c\u00e1c b\u00e1o c\u00e1o n\u00e0y c\u00f3 ph\u1ea3n \u00e1nh \u0111\u00fang v\u1ec1 h\u1ea1 glucose trong m\u00e1u hay kh\u00f4ng.<\/p>\n<p>T\u1ea7n su\u1ea5t x\u1ea3y ra h\u1ea1 glucose trong m\u00e1u khi s\u1eed d\u1ee5ng \u0111\u01a1n tr\u1ecb li\u1ec7u l\u00e0 4% \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 2,5 mg, 5,6% \u0111\u1ed1i v\u1edbi saxagliptin 5 mg so v\u1edbi 4,1% \u0111\u1ed1i v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Trong th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng ph\u1ed1i h\u1ee3p b\u1ed5 sung v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, t\u1ea7n su\u1ea5t x\u1ea3y ra h\u1ea1 glucose huy\u1ebft l\u00e0 7,8% \u0111\u1ed1i v\u1edbi saxagliptin 2,5 mg, 5,8% \u0111\u1ed1i v\u1edbi saxagliptin 5 mg so v\u1edbi 5% \u0111\u1ed1i v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Khi ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u1edf b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3, t\u1ea7n su\u1ea5t x\u1ea3y ra h\u1ea1 glucose huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng saxagliptin 5 mg + metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi l\u00e0 3,4% v\u00e0 t\u1ea7n su\u1ea5t x\u1ea3y ra h\u1ea1 glucose huy\u1ebft l\u00e0 4% tr\u00ean b\u1ec7nh nh\u00e2n d\u00f9ng placebo + metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p>Trong nghi\u00ean c\u1ee9u c\u00f3 ki\u1ec3m so\u00e1t, so s\u00e1nh li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p saxagliptin 5 mg v\u1edbi \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p glipizide tr\u00ean b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft t\u1ed1t v\u1edbi metformin \u0111\u01a1n tr\u1ecb, t\u1ef7 l\u1ec7 h\u1ea1 glucose m\u00e1u \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf nh\u00f3m s\u1eed d\u1ee5ng saxagliptin 5 mg l\u00e0 3% (19 bi\u1ebfn c\u1ed1 trong 13 b\u1ec7nh nh\u00e2n) v\u00e0 \u1edf nh\u00f3m s\u1eed d\u1ee5ng glipizide l\u00e0 36,3% (750 bi\u1ebfn c\u1ed1 trong 156 b\u1ec7nh nh\u00e2n). H\u1ea1 glucose m\u00e1u \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh qua c\u00e1c tri\u1ec7u ch\u1ee9ng h\u1ea1 glucose k\u00e8m theo x\u00e9t nghi\u1ec7m glucose \u1edf \u0111\u1ea7u ng\u00f3n tay \u2264 50 mg\/dL kh\u00f4ng quan s\u00e1t th\u1ea5y \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb saxagliptin v\u00e0 x\u1ea3y ra \u1edf 35 b\u1ec7nh nh\u00e2n (8,1%) (p&lt;0,0001) \u0111i\u1ec1u tr\u1ecb glipizide.<\/p>\n<p>Trong th\u1eed nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p saxagliptin v\u1edbi insulin, t\u1ef7 l\u1ec7 chung c\u00e1c tr\u01b0\u1eddng h\u1ee3p h\u1ea1 glucose trong m\u00e1u \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 18,4% \u0111\u1ed1i v\u1edbi saxagliptin 5 mg v\u00e0 19,9% \u0111\u1ed1i v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Tuy nhi\u00ean, t\u1ea7n su\u1ea5t c\u00e1c tr\u01b0\u1eddng h\u1ee3p h\u1ea1 glucose trong m\u00e1u c\u00f3 tri\u1ec7u ch\u1ee9ng \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh (c\u00f3 k\u00e8m theo x\u00e9t nghi\u1ec7m glucose b\u1eb1ng m\u00e1u \u1edf \u0111\u1ea7u ng\u00f3n tay \u2264 50 mg\/dL) cao h\u01a1n \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 5 mg (5,3%) so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c (3,3%). Trong s\u1ed1 nh\u1eefng b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng insulin ph\u1ed1i h\u1ee3p v\u1edbi metformin, t\u1ea7n su\u1ea5t c\u00e1c tri\u1ec7u ch\u1ee9ng h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh l\u00e0 4,8% \u1edf nh\u00f3m saxagliptin so v\u1edbi 1,9% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>Trong th\u1eed nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p saxagliptin v\u1edbi metformin v\u00e0 sulfonylur\u00ea, t\u1ef7 l\u1ec7 chung c\u00e1c tr\u01b0\u1eddng h\u1ee3p h\u1ea1 glucose trong m\u00e1u \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 10,1% \u0111\u1ed1i v\u1edbi saxagliptin 5 mg v\u00e0 6,3% \u0111\u1ed1i v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. T\u1ea7n su\u1ea5t c\u00e1c tr\u01b0\u1eddng h\u1ee3p h\u1ea1 glucose m\u00e1u \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh l\u00e0 1,6% \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n c\u00f3 d\u00f9ng saxagliptin v\u00e0 kh\u00f4ng c\u00f3 tr\u01b0\u1eddng h\u1ee3p n\u00e0o \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Trong ph\u00e2n t\u00edch g\u1ed9p c\u1ee7a 5 th\u1eed nghi\u1ec7m k\u00e9o d\u00e0i 24 tu\u1ea7n, c\u00e1c bi\u1ebfn c\u1ed1 li\u00ean quan \u0111\u1ebfn qu\u00e1 m\u1eabn nh\u01b0 n\u1ed5i m\u1ec1 \u0111ay, ph\u00f9 m\u1eb7t \u0111\u01b0\u1ee3c ghi nh\u1eadn x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 l\u00e0 1,5% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 2,5 mg, 1,5% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng saxagliptin 5 mg v\u00e0 0,4% \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c. Kh\u00f4ng c\u00f3 b\u1ea5t k\u1ef3 tr\u01b0\u1eddng h\u1ee3p s\u1eed d\u1ee5ng saxagliptin n\u00e0o ph\u1ea3i nh\u1eadp vi\u1ec7n ho\u1eb7c x\u1ea3y ra v\u1edbi m\u1ee9c \u0111\u1ed9 g\u00e2y nguy hi\u1ec3m \u0111\u1ebfn t\u00ednh m\u1ea1ng. C\u00f3 1 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin ng\u01b0ng s\u1eed d\u1ee5ng thu\u1ed1c do n\u1ed5i m\u1ec1 \u0111ay to\u00e0n th\u00e2n v\u00e0 ph\u00f9 m\u1eb7t.<\/p>\n<p><em>Nhi\u1ec5m khu\u1ea9n<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>D\u1eef li\u1ec7u nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng, kh\u00f4ng m\u00f9 c\u1ee7a saxagliptin cho \u0111\u1ebfn nay \u0111\u00e3 ghi nh\u1eadn c\u00f3 6 b\u00e1o c\u00e1o nhi\u1ec5m b\u1ec7nh lao (chi\u1ebfm 0,12%) trong s\u1ed1 4959 b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin (chi\u1ebfm 1,1 tr\u00ean 1000 b\u1ec7nh nh\u00e2n-n\u0103m) so v\u1edbi kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o nhi\u1ec5m b\u1ec7nh lao n\u00e0o trong s\u1ed1 2868 b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi nh\u00f3m ch\u1ee9ng. Hai trong s\u1ed1 s\u00e1u tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng x\u00e9t nghi\u1ec7m. C\u00e1c tr\u01b0\u1eddng h\u1ee3p c\u00f2n l\u1ea1i c\u00f3 th\u00f4ng tin h\u1ea1n ch\u1ebf ho\u1eb7c ch\u1ea9n \u0111o\u00e1n s\u01a1 b\u1ed9 nhi\u1ec5m lao. Kh\u00f4ng c\u00f3 tr\u01b0\u1eddng h\u1ee3p n\u00e0o trong s\u00e1u tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh x\u1ea3y ra \u1edf M\u1ef9 hay T\u00e2y \u00c2u. M\u1ed9t tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh x\u1ea3y ra \u1edf Canada tr\u00ean b\u1ec7nh nh\u00e2n g\u1ed1c Indonesia v\u00e0 g\u1ea7n \u0111\u00e2y c\u00f3 \u0111\u1ebfn du l\u1ecbch Indonesia. Th\u1eddi gian \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin cho \u0111\u1ebfn khi c\u00f3 b\u00e1o c\u00e1o nhi\u1ec5m b\u1ec7nh lao bi\u1ebfn thi\u00ean t\u1eeb 144 \u0111\u1ebfn 929 ng\u00e0y. Ch\u1ec9 s\u1ed1 b\u1ea1ch c\u1ea7u lympho sau khi \u0111i\u1ec1u tr\u1ecb ph\u00f9 h\u1ee3p v\u1edbi d\u00e3y ch\u1ec9 s\u1ed1 tham kh\u1ea3o \u1edf 4 ca b\u1ec7nh. M\u1ed9t b\u1ec7nh nh\u00e2n c\u00f3 gi\u1ea3m b\u1ea1ch c\u1ea7u lympho tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin v\u1eabn trong t\u00ecnh tr\u1ea1ng \u1ed5n \u0111\u1ecbnh su\u1ed1t qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb b\u1eb1ng saxagliptin. B\u1ec7nh nh\u00e2n cu\u1ed1i c\u00f9ng c\u00f3 s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho \u0111\u01b0\u1ee3c ph\u00e2n l\u1eadp th\u1ea5p d\u01b0\u1edbi m\u1ee9c b\u00ecnh th\u01b0\u1eddng kho\u1ea3ng 4 th\u00e1ng tr\u01b0\u1edbc khi b\u00e1o c\u00e1o nhi\u1ec5m b\u1ec7nh lao. Kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o t\u1ef1 ph\u00e1t v\u1ec1 m\u1ed1i li\u00ean quan gi\u1eefa nhi\u1ec5m b\u1ec7nh lao v\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng saxagliptin. Nguy\u00ean nh\u00e2n nhi\u1ec5m lao ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u00e0 cho \u0111\u1ebfn nay c\u00f3 r\u1ea5t \u00edt tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh li\u1ec7u c\u00f3 m\u1ed1i li\u00ean quan gi\u1eefa s\u1eed d\u1ee5ng saxagliptin v\u00e0 nhi\u1ec5m b\u1ec7nh lao.<\/p>\n<p>Trong d\u1eef li\u1ec7u nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng, kh\u00f4ng m\u00f9 cho \u0111\u1ebfn nay \u0111\u00e3 ghi nh\u1eadn c\u00f3 m\u1ed9t tr\u01b0\u1eddng h\u1ee3p nhi\u1ec5m khu\u1ea9n c\u01a1 h\u1ed9i \u1edf b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng saxagliptin, ti\u1ebfn tri\u1ec3n \u0111\u1ebfn t\u1eed vong do nhi\u1ec5m khu\u1ea9n huy\u1ebft nghi do nhi\u1ec5m Salmonella t\u1eeb th\u1ee9c \u0103n sau g\u1ea7n 600 ng\u00e0y \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin. Kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o t\u1ef1 ph\u00e1t v\u1ec1 nhi\u1ec5m khu\u1ea9n c\u01a1 h\u1ed9i c\u00f3 li\u00ean quan \u0111\u1ebfn s\u1eed d\u1ee5ng thu\u1ed1c saxagliptin.<\/p>\n<p><em>D\u1ea5u hi\u1ec7u sinh t\u1ed3n<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Kh\u00f4ng c\u00f3 s\u1ef1 thay \u0111\u1ed5i c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng v\u1ec1 c\u00e1c d\u1ea5u hi\u1ec7u sinh t\u1ed3n \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ch\u1ec9 v\u1edbi saxagliptin hay k\u1ebft h\u1ee3p v\u1edbi metformin.<\/p>\n<p><em>C\u00e1c x\u00e9t nghi\u1ec7m c\u1eadn l\u00e2m s\u00e0ng<\/em><\/p>\n<p>S\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho to\u00e0n ph\u1ea7n<\/p>\n<p>Saxagliptin<\/p>\n<p>C\u00f3 s\u1ef1 gi\u1ea3m s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho to\u00e0n ph\u1ea7n li\u00ean quan \u0111\u1ebfn li\u1ec1u d\u00f9ng, \u0111\u01b0\u1ee3c ghi nh\u1eadn khi \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin. Trong ph\u00e2n t\u00edch g\u1ed9p c\u1ee7a 5 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng k\u00e9o d\u00e0i 24 tu\u1ea7n, v\u1edbi s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho to\u00e0n ph\u1ea7n ban \u0111\u1ea7u kho\u1ea3ng 2200 t\u1ebf b\u00e0o\/microL, s\u1ef1 gi\u1ea3m b\u1ea1ch c\u1ea7u lympho trung b\u00ecnh so v\u1edbi ban \u0111\u1ea7u l\u00e0 kho\u1ea3ng 100 t\u1ebf b\u00e0o\/microL \u0111\u1ed1i v\u1edbi saxagliptin 5 mg v\u00e0 120 t\u1ebf b\u00e0o\/microL \u0111\u1ed1i v\u1edbi saxagliptin 10 mg so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. T\u00e1c d\u1ee5ng t\u01b0\u01a1ng t\u1ef1 \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn khi s\u1eed d\u1ee5ng saxagliptin 5 mg ph\u1ed1i h\u1ee3p v\u1edbi metformin so v\u1edbi ch\u1ec9 s\u1eed d\u1ee5ng metformin \u0111\u01a1n l\u1ebb v\u00e0 gi\u1ea3 d\u01b0\u1ee3c \u1edf b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3. Kh\u00f4ng c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa saxagliptin 2,5 mg so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. T\u1ef7 l\u1ec7 b\u1ec7nh nh\u00e2n c\u00f3 s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho gi\u1ea3m d\u01b0\u1edbi \u2264 750 t\u1ebf b\u00e0o\/microL l\u00e0 0,5% \u0111\u1ed1i v\u1edbi nh\u00f3m s\u1eed d\u1ee5ng saxagliptin 2,5 mg, 1,5% \u0111\u1ed1i v\u1edbi nh\u00f3m s\u1eed d\u1ee5ng saxagliptin 5 mg, 1,4% \u0111\u1ed1i v\u1edbi nh\u00f3m s\u1eed d\u1ee5ng saxagliptin 10 mg, v\u00e0 0,4% \u0111\u1ed1i v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Trong ph\u1ea7n l\u1edbn b\u1ec7nh nh\u00e2n, kh\u00f4ng c\u00f3 hi\u1ec7n t\u01b0\u1ee3ng t\u00e1i di\u1ec5n gi\u1ea3m b\u1ea1ch c\u1ea7u lympho khi t\u00e1i s\u1eed d\u1ee5ng saxagliptin m\u1eb7c d\u00f9 c\u00f3 m\u1ed9t v\u00e0i b\u1ec7nh nh\u00e2n c\u00f3 s\u1ef1 gi\u1ea3m b\u1ea1ch c\u1ea7u tr\u1edf l\u1ea1i v\u00e0 ph\u1ea3i ng\u01b0ng thu\u1ed1c. S\u1ef1 gi\u1ea3m s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho kh\u00f4ng li\u00ean quan \u0111\u1ebfn c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 t\u01b0\u01a1ng \u1ee9ng tr\u00ean l\u00e2m s\u00e0ng. Li\u1ec1u saxagliptin 10 mg kh\u00f4ng ph\u1ea3i li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/p>\n<p>\u00dd ngh\u0129a l\u00e2m s\u00e0ng c\u1ee7a s\u1ef1 gi\u1ea3m s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho li\u00ean quan \u0111\u1ebfn gi\u1ea3 d\u01b0\u1ee3c ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh. Khi c\u00f3 ch\u1ec9 \u0111\u1ecbnh l\u00e2m s\u00e0ng, v\u00ed d\u1ee5 nh\u01b0 nhi\u1ec5m tr\u00f9ng b\u1ea5t th\u01b0\u1eddng ho\u1eb7c k\u00e9o d\u00e0i th\u00ec c\u1ea7n ph\u1ea3i x\u00e9t nghi\u1ec7m \u0111\u1ebfm s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho. T\u00e1c \u0111\u1ed9ng c\u1ee7a saxagliptin tr\u00ean s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho \u1edf b\u1ec7nh nh\u00e2n b\u1ea5t th\u01b0\u1eddng v\u1ec1 b\u1ea1ch c\u1ea7u lympho (v\u00ed d\u1ee5 nh\u01b0 nhi\u1ec5m virus HIV) v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c bi\u1ebft.<\/p>\n<p>Trong nghi\u00ean c\u1ee9u SAVOR, s\u1ef1 gi\u1ea3m s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u lympho \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf 0,5% b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin v\u00e0 0,4% b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p><em>N\u1ed3ng \u0111\u1ed9 vitamin B12<\/em><\/p>\n<p>Metformin hydroclorid<\/p>\n<p>Metformin c\u00f3 th\u1ec3 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 vitamin B12 trong huy\u1ebft thanh. \u0110\u1ecbnh l\u01b0\u1ee3ng c\u00e1c th\u00f4ng s\u1ed1 huy\u1ebft h\u1ecdc h\u00e0ng n\u0103m \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o \u1edf c\u00e1c b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng KOMBOGLYZE XR v\u00e0 n\u00ean ki\u1ec3m tra v\u00e0 b\u1ea5t k\u1ef3 m\u1ed9t bi\u1ec3u hi\u1ec7n b\u1ea5t th\u01b0\u1eddng n\u00e0o c\u0169ng n\u00ean \u0111\u01b0\u1ee3c kh\u1ea3o s\u00e1t v\u00e0 x\u1eed tr\u00ed m\u1ed9t c\u00e1ch th\u00edch h\u1ee3p (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Kinh nghi\u1ec7m khi thu\u1ed1c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng<\/em><\/p>\n<p>C\u00f3 th\u00eam c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh sau khi saxagliptin l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng. Do c\u00e1c ph\u1ea3n \u1ee9ng ghi nh\u1eadn t\u1ef1 ph\u00e1t t\u1eeb m\u1ed9t qu\u1ea7n th\u1ec3 kh\u00f4ng x\u00e1c \u0111\u1ecbnh s\u1ed1 l\u01b0\u1ee3ng n\u00ean kh\u00f4ng th\u1ec3 \u01b0\u1edbc t\u00ednh \u0111\u00fang t\u1ea7n su\u1ea5t ho\u1eb7c x\u00e1c l\u1eadp m\u1ed1i quan h\u1ec7 nh\u00e2n qu\u1ea3 v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c.<\/p>\n<p>C\u00e1c ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn nh\u01b0 ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7, ph\u00f9 m\u1ea1ch ho\u1eb7c c\u00e1c t\u00ecnh tr\u1ea1ng da tr\u00f3c v\u1ea3y (xem ph\u1ea7n Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v\u00e0 ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p>Vi\u00eam t\u1ee5y c\u1ea5p (xem ph\u1ea7n Ch\u1ec9 \u0111\u1ecbnh v\u00e0 ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p>\u0110au kh\u1edbp (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Th\u00f4ng b\u00e1o cho B\u00e1c s\u0129 nh\u1eefng t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n g\u1eb7p ph\u1ea3i khi s\u1eed d\u1ee5ng thu\u1ed1c.<\/em><\/p>\n<p><em><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/em><\/p>\n<h3><span class=\"ez-toc-section\" id=\"47-huong-dan-cach-xu-tri-adr\"><\/span>4.7 H\u01b0\u1edbng d\u1eabn c\u00e1ch x\u1eed tr\u00ed ADR:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Ng\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c. V\u1edbi c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nh\u1eb9, th\u01b0\u1eddng ch\u1ec9 c\u1ea7n ng\u1eebng thu\u1ed1c. Tr\u01b0\u1eddng h\u1ee3p m\u1eabn c\u1ea3m n\u1eb7ng ho\u1eb7c ph\u1ea3n \u1ee9ng d\u1ecb \u1ee9ng, c\u1ea7n ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 (gi\u1eef tho\u00e1ng kh\u00ed v\u00e0 d\u00f9ng epinephrin, th\u1edf oxygen, d\u00f9ng kh\u00e1ng histamin, corticoid&#8230;).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"48-tuong-tac-voi-cac-thuoc-khac\"><\/span>4.8 T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>*Thu\u1ed1c \u1ee9c ch\u1ebf m\u1ea1nh enzyme CYP3A4\/5<\/em><\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Ketoconazole l\u00e0m t\u0103ng \u0111\u00e1ng k\u1ec3 n\u1ed3ng \u0111\u1ed9 saxagliptin trong c\u01a1 th\u1ec3. T\u01b0\u01a1ng t\u1ef1, s\u1ef1 gia t\u0103ng n\u1ed3ng \u0111\u1ed9 c\u1ee7a saxagliptin trong huy\u1ebft t\u01b0\u01a1ng c\u0169ng x\u1ea3y ra khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi c\u00e1c thu\u1ed1c \u1ee9c ch\u1ebf m\u1ea1nh CYP3A4\/5 (v\u00ed d\u1ee5 nh\u01b0 atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir v\u00e0 telithromycin).<\/p>\n<p><em>*Thu\u1ed1c ion d\u01b0\u01a1ng h\u00f3a (cationic)<\/em><\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>V\u1ec1 m\u1eb7t l\u00fd thuy\u1ebft, c\u00e1c thu\u1ed1c ion d\u01b0\u01a1ng h\u00f3a (v\u00ed d\u1ee5 nh\u01b0 amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, ho\u1eb7c vancomycin) \u0111\u01b0\u1ee3c \u0111\u00e0o th\u1ea3i qua s\u1ef1 b\u00e0i ti\u1ebft c\u1ee7a \u1ed1ng th\u1eadn, c\u00f3 kh\u1ea3 n\u0103ng t\u01b0\u01a1ng t\u00e1c v\u1edbi metformin b\u1eb1ng c\u00e1ch c\u1ea1nh tranh tr\u00ean h\u1ec7 th\u1ed1ng v\u1eadn chuy\u1ec3n th\u00f4ng th\u01b0\u1eddng t\u1ea1i \u1ed1ng th\u1eadn. S\u1ef1 t\u01b0\u01a1ng t\u00e1c gi\u1eefa metformin v\u00e0 cimetidine \u0111\u01b0\u1eddng u\u1ed1ng theo d\u1ea1ng n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean ng\u01b0\u1eddi t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh. M\u1eb7c d\u00f9 t\u01b0\u01a1ng t\u00e1c d\u1ea1ng n\u00e0y ch\u1ec9 t\u1ed3n t\u1ea1i v\u1ec1 m\u1eb7t l\u00fd thuy\u1ebft (ngo\u1ea1i tr\u1eeb tr\u01b0\u1eddng h\u1ee3p cimetidine), v\u1eabn n\u00ean khuy\u1ebfn c\u00e1o th\u1eadn tr\u1ecdng theo d\u00f5i b\u1ec7nh nh\u00e2n ch\u1eb7t ch\u1ebd v\u00e0 \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u c\u1ee7a KOMBOGLYZE XR v\u00e0\/ho\u1eb7c d\u00f9ng th\u00eam thu\u1ed1c can thi\u1ec7p \u1edf c\u00e1c b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng thu\u1ed1c catinonic b\u00e0i ti\u1ebft qua h\u1ec7 th\u1ed1ng \u1ed1ng th\u1eadn g\u1ea7n.<\/p>\n<p><em>*S\u1eed d\u1ee5ng c\u00f9ng v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c<\/em><\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>M\u1ed9t s\u1ed1 thu\u1ed1c c\u00f3 th\u1ec3 g\u00e2y ra t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft v\u00e0 d\u1eabn \u0111\u1ebfn m\u1ea5t ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft. C\u00e1c thu\u1ed1c n\u00e0y bao g\u1ed3m: thiazide v\u00e0 c\u00e1c thu\u1ed1c l\u1ee3i ti\u1ec3u kh\u00e1c, corticosteroid, phenothiazine, ch\u1ebf ph\u1ea9m tuy\u1ebfn gi\u00e1p, hormone sinh d\u1ee5c n\u1eef, thu\u1ed1c ng\u1eeba thai \u0111\u01b0\u1eddng u\u1ed1ng, phenytoin, acid nicotinic, thu\u1ed1c k\u00edch th\u00edch th\u1ea7n kinh giao c\u1ea3m, thu\u1ed1c \u1ee9c ch\u1ebf k\u00eanh calci v\u00e0 isoniazid. Khi d\u00f9ng c\u00e1c thu\u1ed1c tr\u00ean \u1edf b\u1ec7nh nh\u00e2n \u0111ang \u0111i\u1ec1u tr\u1ecb KOMBOGLYZE XR, b\u1ec7nh nh\u00e2n n\u00ean \u0111\u01b0\u1ee3c theo d\u00f5i ch\u1eb7t ch\u1ebd t\u00ecnh tr\u1ea1ng m\u1ea5t ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft. Khi ng\u01b0ng d\u00f9ng nh\u1eefng thu\u1ed1c n\u00e0y \u1edf b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng KOMBOGLYZE XR, n\u00ean theo d\u00f5i ch\u1eb7t ch\u1ebd b\u1ec7nh nh\u00e2n \u0111\u1ec3 tr\u00e1nh t\u00ecnh tr\u1ea1ng t\u1ee5t \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p><em>*R\u01b0\u1ee3u (alcohol)<\/em><\/p>\n<p>T\u0103ng nguy c\u01a1 nhi\u1ec5m acid lactic khi ng\u1ed9 \u0111\u1ed9c r\u01b0\u1ee3u c\u1ea5p t\u00ednh (\u0111\u1eb7c bi\u1ec7t trong tr\u01b0\u1eddng h\u1ee3p \u0111\u00f3i, suy dinh d\u01b0\u1ee1ng ho\u1eb7c suy gan) do ho\u1ea1t ch\u1ea5t metformin c\u00f3 trong KOMBOGLYZE XR (xem ph\u1ea7n C\u1ea3nh b\u00e1o). N\u00ean tr\u00e1nh s\u1eed d\u1ee5ng r\u01b0\u1ee3u v\u00e0 c\u00e1c ch\u1ebf ph\u1ea9m ch\u1ee9a r\u01b0\u1ee3u.<\/p>\n<p><em>*Ch\u1ea5t c\u1ea3n quang ch\u1ee9a iod<\/em><\/p>\n<p>C\u00e1c ch\u1ea5t c\u1ea3n quang ch\u1ee9a iod \u0111\u01b0\u1ee3c ti\u00eam v\u00e0o l\u00f2ng m\u1ea1ch m\u00e1u trong ch\u1ee5p X-quang c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn suy th\u1eadn, g\u00e2y ra t\u00edch l\u0169y metformin v\u00e0 nguy c\u01a1 nhi\u1ec5m acid lactic. Do \u0111\u00f3, b\u1ec7nh nh\u00e2n ph\u1ea3i ng\u1eebng KOMBOGLYZE XR tr\u01b0\u1edbc, ho\u1eb7c t\u1ea1i th\u1eddi \u0111i\u1ec3m ch\u1ee5p v\u00e0 kh\u00f4ng d\u00f9ng thu\u1ed1c trong v\u00f2ng 48 gi\u1edd sau \u0111\u00f3, ch\u1ec9 ti\u1ebfp t\u1ee5c d\u00f9ng thu\u1ed1c sau khi ch\u1ee9c n\u0103ng th\u1eadn \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u1ea1i v\u00e0 x\u00e1c nh\u1eadn l\u00e0 b\u00ecnh th\u01b0\u1eddng (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"49-qua-lieu-va-xu-tri\"><\/span>4.9 Qu\u00e1 li\u1ec1u v\u00e0 x\u1eed tr\u00ed:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Trong m\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng, d\u00f9ng saxagliptin \u0111\u01b0\u1eddng u\u1ed1ng ng\u00e0y 1 l\u1ea7n tr\u00ean \u0111\u1ed1i t\u01b0\u1ee3ng kh\u1ecfe m\u1ea1nh v\u1edbi li\u1ec1u t\u1ed1i \u0111a l\u00ean \u0111\u1ebfn 400 mg\/ng\u00e0y trong 2 tu\u1ea7n (g\u1ea5p 80 l\u1ea7n li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o \u1edf ng\u01b0\u1eddi), kh\u00f4ng c\u00f3 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n li\u00ean quan \u0111\u1ebfn li\u1ec1u s\u1eed d\u1ee5ng tr\u00ean l\u00e2m s\u00e0ng v\u00e0 kh\u00f4ng c\u00f3 s\u1ef1 thay \u0111\u1ed5i c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng v\u1ec1 kho\u1ea3ng QTc ho\u1eb7c nh\u1ecbp tim.<\/p>\n<p>Trong tr\u01b0\u1eddng h\u1ee3p qu\u00e1 li\u1ec1u, c\u1ea7n \u00e1p d\u1ee5ng c\u00e1c bi\u1ec7n ph\u00e1p \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 th\u00edch h\u1ee3p d\u1ef1a tr\u00ean t\u00ecnh tr\u1ea1ng l\u00e2m s\u00e0ng c\u1ee7a b\u1ec7nh nh\u00e2n. Saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb qua l\u1ecdc m\u00e1u (23% li\u1ec1u trong 4 gi\u1edd).<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>\u0110\u00e3 t\u1eebng x\u1ea3y ra qu\u00e1 li\u1ec1u metformin hydroclorid, k\u1ec3 c\u1ea3 d\u00f9ng li\u1ec1u tr\u00ean 50 gam. Kho\u1ea3ng 10% ca h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o, nh\u01b0ng ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c li\u1ec7u c\u00f3 li\u00ean quan \u0111\u1ebfn d\u00f9ng metformin hydroclorid hay kh\u00f4ng. Kho\u1ea3ng 32% ca d\u00f9ng qu\u00e1 li\u1ec1u metformin b\u1ecb nhi\u1ec5m toan ax\u00edt lactic (xem ph\u1ea7n C\u1ea3nh b\u00e1o). \u0110\u1ed9 thanh th\u1ea3i c\u1ee7a metformin l\u00ean \u0111\u1ebfn 170 mL\/ph\u00fat trong t\u00ecnh tr\u1ea1ng huy\u1ebft \u0111\u1ed9ng t\u1ed1t. Do \u0111\u00f3, l\u1ecdc m\u00e1u c\u00f3 th\u1ec3 gi\u00fap lo\u1ea1i tr\u1eeb thu\u1ed1c b\u1ecb t\u00edch t\u1ee5 ra kh\u1ecfi c\u01a1 th\u1ec3 \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n nghi ng\u1edd d\u00f9ng qu\u00e1 li\u1ec1u metformin.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5-co-che-tac-dung-cua-thuoc\"><\/span>5. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c :<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"51-duoc-luc-hoc\"><\/span>5.1. D\u01b0\u1ee3c l\u1ef1c h\u1ecdc:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>KOMBOGLYZE XR k\u1ebft h\u1ee3p hai thu\u1ed1c ch\u1ed1ng t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft v\u1edbi c\u01a1 ch\u1ebf ho\u1ea1t \u0111\u1ed9ng b\u1ed5 sung nh\u1eb1m c\u1ea3i thi\u1ec7n vi\u1ec7c ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2: saxagliptin, m\u1ed9t thu\u1ed1c \u1ee9c ch\u1ebf men dipeptidyl-peptidase-4 (DPP4) v\u00e0 metformin hydroclorid, m\u1ed9t biguanide.<\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>N\u1ed3ng \u0111\u1ed9 c\u1ee7a c\u00e1c hormone incretin nh\u01b0 GLP-1 (glucagon-like peptide-1) v\u00e0 GIP (glucose-dependent insulinotropic polypeptide) gia t\u0103ng do s\u1ef1 ph\u00f3ng th\u00edch c\u00e1c hormone n\u00e0y t\u1eeb ru\u1ed9t non v\u00e0o m\u00e1u sau \u0111\u00e1p \u1ee9ng v\u1edbi b\u1eefa \u0103n. Nh\u1eefng hormone n\u00e0y g\u00e2y ph\u00f3ng th\u00edch insulin t\u1eeb t\u1ebf b\u00e0o beta c\u1ee7a tuy\u1ebfn t\u1ee5y t\u00f9y thu\u1ed9c v\u00e0o n\u1ed3ng \u0111\u1ed9 glucose, nh\u01b0ng s\u1ebd b\u1ecb b\u1ea5t ho\u1ea1t b\u1edfi enzyme DPP4 (dipeptidyl peptidase-4) trong v\u00f2ng v\u00e0i ph\u00fat. GLP-1 c\u0169ng l\u00e0m gi\u1ea3m l\u01b0\u1ee3ng glucagon ti\u1ebft ra t\u1eeb t\u1ebf b\u00e0o alpha c\u1ee7a tuy\u1ebfn t\u1ee5y, l\u00e0m gi\u1ea3m s\u1ef1 t\u1ed5ng h\u1ee3p glucose \u1edf gan. \u1ede b\u1ec7nh nh\u00e2n b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, n\u1ed3ng \u0111\u1ed9 GLP-1 gi\u1ea3m nh\u01b0ng \u0111\u00e1p \u1ee9ng c\u1ee7a insulin v\u1edbi GLP-1 v\u1eabn kh\u00f4ng thay \u0111\u1ed5i. Saxagliptin l\u00e0 thu\u1ed1c \u1ee9c ch\u1ebf c\u1ea1nh tranh DPP4 l\u00e0m gi\u1ea3m s\u1ef1 b\u1ea5t ho\u1ea1t c\u1ee7a hormone incretin, v\u00ec th\u1ebf l\u00e0m t\u0103ng n\u1ed3ng \u0111\u1ed9 c\u1ee7a c\u00e1c hormone n\u00e0y trong m\u00e1u v\u00e0 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 glucose l\u00fac \u0111\u00f3i v\u00e0 sau b\u1eefa \u0103n t\u00f9y thu\u1ed9c v\u00e0o l\u01b0\u1ee3ng glucose \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2.<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>Metformin c\u1ea3i thi\u1ec7n s\u1ef1 dung n\u1ea1p glucose \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, h\u1ea1 c\u1ea3 glucose huy\u1ebft c\u01a1 b\u1ea3n v\u00e0 sau \u0103n. Metformin l\u00e0m gi\u1ea3m s\u1ef1 t\u1ed5ng h\u1ee3p glucose \u1edf gan, gi\u1ea3m h\u1ea5p thu glucose \u1edf ru\u1ed9t v\u00e0 c\u1ea3i thi\u1ec7n \u0111\u1ed9 nh\u1ea1y c\u1ea3m v\u1edbi insulin th\u00f4ng qua gia t\u0103ng h\u1ea5p thu v\u00e0 s\u1eed d\u1ee5ng glucose ngo\u1ea1i vi. Kh\u00f4ng gi\u1ed1ng nh\u01b0 sulfonylur\u00ea, metformin kh\u00f4ng g\u00e2y h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 ho\u1eb7c c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng kh\u1ecfe m\u1ea1nh ngo\u1ea1i tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p b\u1ea5t th\u01b0\u1eddng (xem C\u1ea3nh b\u00e1o) v\u00e0 kh\u00f4ng g\u00e2y t\u0103ng insulin huy\u1ebft. Khi \u0111i\u1ec1u tr\u1ecb v\u1edbi metformin, s\u1ef1 b\u00e0i ti\u1ebft insulin kh\u00f4ng \u0111\u1ed5i d\u00f9 n\u1ed3ng \u0111\u1ed9 insulin l\u00fac \u0111\u00f3i v\u00e0 m\u1ee9c \u0111\u00e1p \u1ee9ng insulin huy\u1ebft t\u01b0\u01a1ng trong ng\u00e0y c\u00f3 th\u1ec3 th\u1eadt s\u1ef1 gi\u1ea3m.<\/p>\n<p><em>*D\u01b0\u1ee3c L\u1ef1c H\u1ecdc<\/em><\/p>\n<p><em>Saxagliptin: <\/em>\u1ede c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, s\u1eed d\u1ee5ng saxagliptin s\u1ebd \u1ee9c ch\u1ebf ho\u1ea1t t\u00ednh enzyme DPP-4 trong 24 gi\u1edd. Sau khi s\u1eed d\u1ee5ng glucose qua \u0111\u01b0\u1eddng u\u1ed1ng ho\u1eb7c sau b\u1eefa \u0103n, s\u1ef1 \u1ee9c ch\u1ebf DPP-4 s\u1ebd l\u00e0m t\u0103ng 2-3 l\u1ea7n n\u1ed3ng \u0111\u1ed9 hormone GLP-1 v\u00e0 GIP c\u00f3 ho\u1ea1t t\u00ednh trong m\u00e1u, l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 glucagon v\u00e0 t\u0103ng s\u1ef1 ph\u00f3ng th\u00edch insulin t\u1eeb t\u1ebf b\u00e0o beta c\u1ee7a tuy\u1ebfn t\u1ee5y t\u00f9y thu\u1ed9c v\u00e0o n\u1ed3ng \u0111\u1ed9 glucose. S\u1ef1 t\u0103ng n\u1ed3ng \u0111\u1ed9 insulin v\u00e0 gi\u1ea3m n\u1ed3ng \u0111\u1ed9 glucagon c\u00f3 li\u00ean quan \u0111\u1ebfn vi\u1ec7c l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 glucose l\u00fac \u0111\u00f3i v\u00e0 gi\u1ea3m glucose sau khi u\u1ed1ng glucose hay sau b\u1eefa \u0103n.<\/p>\n<p><em>*Sinh l\u00fd \u0111i\u1ec7n tim<\/em><\/p>\n<p><em>Saxagliptin: <\/em>Trong 1 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, ch\u00e9o 4, s\u1eed d\u1ee5ng thu\u1ed1c \u0111\u1ed1i ch\u1ee9ng l\u00e0 moxifloxacin tr\u00ean 40 \u0111\u1ed1i t\u01b0\u1ee3ng kh\u1ecfe m\u1ea1nh, saxagliptin kh\u00f4ng li\u00ean quan v\u1edbi s\u1ef1 k\u00e9o d\u00e0i kho\u1ea3ng QTc hay nh\u1ecbp tim \u0111\u00e1ng k\u1ec3 tr\u00ean l\u00e2m s\u00e0ng \u1edf li\u1ec1u l\u00ean \u0111\u1ebfn 40 mg\/ng\u00e0y (g\u1ea5p 8 l\u1ea7n li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng).<\/p>\n<p><strong><em>C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng: <\/em><\/strong><\/p>\n<p>Saxagliptin l\u00e0 thu\u1ed1c \u1ee9c ch\u1ebf c\u1ea1nh tranh DPP4 l\u00e0m gi\u1ea3m s\u1ef1 b\u1ea5t ho\u1ea1t c\u1ee7a hormone incretin, v\u00ec th\u1ebf l\u00e0m t\u0103ng n\u1ed3ng \u0111\u1ed9 c\u1ee7a c\u00e1c hormon n\u00e0y trong m\u00e1u v\u00e0 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 glucose l\u00fac \u0111\u00f3i v\u00e0 sau b\u1eefa \u0103n t\u00f9y thu\u1ed9c v\u00e0o l\u01b0\u1ee3ng glucose \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2.<\/p>\n<p><em>Metformin<\/em> ho\u1ea1t \u0111\u1ed9ng qua 3 c\u01a1 ch\u1ebf:<\/p>\n<p>Gi\u1ea3m s\u1ea3n xu\u1ea5t glucose \u1edf gan b\u1eb1ng c\u00e1ch \u1ee9c ch\u1ebf t\u00e2n t\u1ea1o \u0111\u01b0\u1eddng v\u00e0 ph\u00e2n h\u1ee7y glycogen<\/p>\n<p>T\u1ea1i c\u01a1, gia t\u0103ng s\u1ef1 nh\u1ea1y c\u1ea3m c\u1ee7a insulin, c\u1ea3i thi\u1ec7n vi\u1ec7c s\u1eed d\u1ee5ng glucose \u1edf ngo\u1ea1i bi\u00ean<\/p>\n<p>L\u00e0m ch\u1eadm h\u1ea5p thu glucose \u1edf ru\u1ed9t<\/p>\n<p>Metformin k\u00edch th\u00edch s\u1ef1 t\u1ed5ng h\u1ee3p glycogen \u1edf t\u1ebf b\u00e0o b\u1eb1ng c\u00e1ch t\u00e1c \u0111\u1ed9ng l\u00ean men glycogen synthase.<\/p>\n<p>Metformin gia t\u0103ng kh\u1ea3 n\u0103ng v\u1eadn chuy\u1ec3n c\u1ee7a c\u00e1c lo\u1ea1i v\u1eadn chuy\u1ec3n glucose qua m\u00e0ng (GLUT).<\/p>\n<p><strong>[XEM T\u1ea0I \u0110\u00c2Y]<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"52-duoc-dong-hoc\"><\/span>5.2. D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>KOMBOGLYZE XR<\/p>\n<p>T\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc v\u00e0 \u1ea3nh h\u01b0\u1edfng c\u1ee7a th\u1ee9c \u0103n \u0111\u1ebfn KOMBOGLYZE XR \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 theo ch\u1ebf \u0111\u1ed9 \u0103n n\u0103ng l\u01b0\u1ee3ng th\u1ea5p. Ch\u1ebf \u0111\u1ed9 \u0103n n\u0103ng l\u01b0\u1ee3ng th\u1ea5p g\u1ed3m 324 kCal trong kh\u1ea9u ph\u1ea7n \u0103n ch\u1ee9a 11,1% protein, 10,5% ch\u1ea5t b\u00e9o v\u00e0 78,4% carbohydrate. K\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc tr\u00ean nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh cho th\u1ea5y vi\u00ean n\u00e9n k\u1ebft h\u1ee3p KOMBOGLYZE XR \u0111\u1ea1t t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc so v\u1edbi khi u\u1ed1ng ph\u1ed1i h\u1ee3p t\u1eebng vi\u00ean ri\u00eang l\u1ebb v\u1edbi c\u00e1c li\u1ec1u t\u01b0\u01a1ng \u1ee9ng saxagliptin (ONGLYZA) v\u00e0 metformin hydroclorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i tr\u00ean t\u00ecnh tr\u1ea1ng \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u00e3 d\u00f9ng th\u1ee9c \u0103n.<\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh, 5-hydroxy saxagliptin l\u00e0 t\u01b0\u01a1ng t\u1ef1 nhau gi\u1eefa \u0111\u1ed1i t\u01b0\u1ee3ng t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh v\u00e0 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2. Cmax v\u00e0 AUC c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh t\u0103ng t\u1ec9 l\u1ec7 theo li\u1ec1u l\u01b0\u1ee3ng saxagliptin s\u1eed d\u1ee5ng trong kho\u1ea3ng li\u1ec1u t\u1eeb 2,5 mg \u0111\u1ebfn 400 mg. Sau khi u\u1ed1ng 5 mg li\u1ec1u \u0111\u01a1n saxagliptin \u1edf ng\u01b0\u1eddi t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh, tr\u1ecb s\u1ed1 AUC trung b\u00ecnh trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 l\u1ea7n l\u01b0\u1ee3t l\u00e0 78 ng\u2022gi\u1edd\/mL v\u00e0 214 ng\u2022gi\u1edd\/mL. Tr\u1ecb s\u1ed1 Cmax trong huy\u1ebft t\u01b0\u01a1ng t\u01b0\u01a1ng \u1ee9ng l\u00e0 24 ng\/mL v\u00e0 47 ng\/mL. H\u1ec7 s\u1ed1 bi\u1ebfn thi\u00ean n\u1ed9i c\u00e1 th\u1ec3 trung b\u00ecnh (% CV) v\u1ec1 Cmax v\u00e0 AUC c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 d\u01b0\u1edbi 25%.<\/p>\n<p>Kh\u00f4ng c\u00f3 s\u1ef1 t\u00edch l\u0169y saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 \u0111\u01b0\u1ee3c ghi nh\u1eadn khi s\u1eed d\u1ee5ng l\u1eb7p l\u1ea1i c\u00e1c li\u1ec1u 1 l\u1ea7n\/ng\u00e0y \u1edf b\u1ea5t k\u1ef3 li\u1ec1u l\u01b0\u1ee3ng n\u00e0o. Kh\u00f4ng c\u00f3 s\u1ef1 l\u1ec7 thu\u1ed9c v\u00e0o li\u1ec1u l\u01b0\u1ee3ng v\u00e0 th\u1eddi gian \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean s\u1ef1 thanh th\u1ea3i saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 trong 14 ng\u00e0y s\u1eed d\u1ee5ng li\u1ec1u saxagliptin 1 l\u1ea7n\/ng\u00e0y trong kho\u1ea3ng li\u1ec1u t\u1eeb 2,5-400 mg.<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>Metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i c\u00f3 Cmax \u0111\u1ea1t gi\u00e1 tr\u1ecb trung v\u1ecb sau 7 gi\u1edd v\u00e0 dao \u0111\u1ed9ng t\u1eeb 4 \u0111\u1ebfn 8 gi\u1edd. \u1ede tr\u1ea1ng th\u00e1i \u1ed5n \u0111\u1ecbnh, metformin c\u00f3 AUC v\u00e0 Cmax th\u1ea5p h\u01a1n t\u1ec9 l\u1ec7 theo li\u1ec1u l\u01b0\u1ee3ng metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i s\u1eed d\u1ee5ng trong kho\u1ea3ng li\u1ec1u t\u1eeb 500 \u0111\u1ebfn 2000 mg. Sau khi d\u00f9ng li\u1ec1u l\u1eb7p l\u1ea1i metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i, metformin kh\u00f4ng t\u00edch l\u0169y trong m\u00e1u. Metformin \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft d\u01b0\u1edbi d\u1ea1ng kh\u00f4ng \u0111\u1ed5i qua n\u01b0\u1edbc ti\u1ec3u v\u00e0 kh\u00f4ng b\u1ecb chuy\u1ec3n h\u00f3a qua gan. N\u1ed3ng \u0111\u1ed9 \u0111\u1ec9nh trong m\u00e1u c\u1ee7a vi\u00ean n\u00e9n ph\u00f3ng th\u00edch k\u00e9o d\u00e0i metformin th\u1ea5p h\u01a1n kho\u1ea3ng 20% so v\u1edbi c\u00f9ng m\u1ee9c li\u1ec1u vi\u00ean n\u00e9n ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, tuy nhi\u00ean, m\u1ee9c \u0111\u1ed9 h\u1ea5p thu (t\u00ednh theo AUC) t\u01b0\u01a1ng t\u1ef1 nhau gi\u1eefa vi\u00ean n\u00e9n ph\u00f3ng th\u00edch k\u00e9o d\u00e0i v\u00e0 vi\u00ean n\u00e9n ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p><em>H\u1ea4P THU<\/em><\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Th\u1eddi gian trung b\u00ecnh \u0111\u1ec3 \u0111\u1ea1t n\u1ed3ng \u0111\u1ed9 t\u1ed1i \u0111a trong huy\u1ebft t\u01b0\u01a1ng (Tmax) sau khi s\u1eed d\u1ee5ng li\u1ec1u 5 mg 1 l\u1ea7n\/ng\u00e0y l\u00e0 2 gi\u1edd \u0111\u1ed1i v\u1edbi saxagliptin v\u00e0 4 gi\u1edd \u0111\u1ed1i v\u1edbi ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh. S\u1eed d\u1ee5ng c\u00f9ng l\u00fac v\u1edbi th\u1ee9c \u0103n nhi\u1ec1u ch\u1ea5t b\u00e9o l\u00e0m t\u0103ng Tmax c\u1ee7a saxagliptin kho\u1ea3ng 20 ph\u00fat so v\u1edbi l\u00fac \u0111\u00f3i. AUC c\u1ee7a saxagliptin t\u0103ng kho\u1ea3ng 27% khi s\u1eed d\u1ee5ng c\u00f9ng v\u1edbi th\u1ee9c \u0103n so v\u1edbi l\u00fac \u0111\u00f3i. Saxagliptin c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong ho\u1eb7c ngo\u00e0i b\u1eefa \u0103n. Th\u1ee9c \u0103n kh\u00f4ng \u1ea3nh h\u01b0\u1edfng c\u00f3 \u00fd ngh\u0129a \u0111\u1ebfn d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin khi \u0111\u01b0\u1ee3c d\u00f9ng d\u01b0\u1edbi d\u1ea1ng vi\u00ean n\u00e9n k\u1ebft h\u1ee3p KOMBOGLYZE XR.<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>Sau khi u\u1ed1ng li\u1ec1u \u0111\u01a1n metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i, Cmax \u0111\u1ea1t gi\u00e1 tr\u1ecb trung v\u1ecb sau 7 gi\u1edd v\u00e0 dao \u0111\u1ed9ng t\u1eeb 4 \u0111\u1ebfn 8 gi\u1edd. M\u1eb7c d\u00f9 m\u1ee9c \u0111\u1ed9 h\u1ea5p thu c\u1ee7a metformin (t\u00ednh theo AUC) d\u01b0\u1edbi d\u1ea1ng vi\u00ean n\u00e9n ph\u00f3ng th\u00edch k\u00e9o d\u00e0i t\u0103ng l\u00ean kho\u1ea3ng 50% khi d\u00f9ng chung v\u1edbi th\u1ee9c \u0103n, th\u1ee9c \u0103n kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn Cmax v\u00e0 Tmax c\u1ee7a metformin. C\u1ea3 b\u1eefa \u0103n gi\u00e0u v\u00e0 \u00edt ch\u1ea5t b\u00e9o \u0111\u1ec1u c\u00f3 t\u00e1c \u0111\u1ed9ng t\u01b0\u01a1ng t\u1ef1 nhau \u0111\u1ebfn d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i. Th\u1ee9c \u0103n kh\u00f4ng \u1ea3nh h\u01b0\u1edfng c\u00f3 \u00fd ngh\u0129a \u0111\u1ebfn d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin khi d\u00f9ng d\u01b0\u1edbi d\u1ea1ng vi\u00ean n\u00e9n ph\u1ed1i h\u1ee3p KOMBOGLYZE XR.<\/p>\n<p><em>PH\u00c2N B\u1ed0<\/em><\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Nghi\u00ean c\u1ee9u in vitro cho th\u1ea5y kh\u1ea3 n\u0103ng g\u1eafn k\u1ebft c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 v\u1edbi protein huy\u1ebft thanh ng\u01b0\u1eddi kh\u00f4ng \u0111\u00e1ng k\u1ec3. V\u00ec th\u1ebf, nh\u1eefng thay \u0111\u1ed5i v\u1ec1 h\u00e0m l\u01b0\u1ee3ng protein m\u00e1u trong c\u00e1c t\u00ecnh tr\u1ea1ng b\u1ec7nh kh\u00e1c nhau (v\u00ed d\u1ee5 nh\u01b0 suy th\u1eadn ho\u1eb7c suy gan) s\u1ebd kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ef1 ph\u00e2n b\u1ed1 c\u1ee7a saxagliptin.<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>C\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 s\u1ef1 ph\u00e2n b\u1ed1 c\u1ee7a metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i ch\u01b0a \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n; tuy nhi\u00ean, th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 bi\u1ec3u ki\u1ebfn (V\/F) c\u1ee7a metformin sau khi u\u1ed1ng li\u1ec1u \u0111\u01a1n metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi 850 mg trung b\u00ecnh l\u00e0 654 \u00b1 358 L. Kh\u00e1c v\u1edbi sulfonylur\u00ea g\u1eafn k\u1ebft v\u1edbi protein h\u01a1n 90%, metformin g\u1eafn k\u1ebft kh\u00f4ng \u0111\u00e1ng k\u1ec3 v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng. Metformin c\u00f3 ph\u1ea7n t\u00edch l\u0169y trong h\u1ed3ng c\u1ea7u, r\u1ea5t c\u00f3 kh\u1ea3 n\u0103ng theo th\u1eddi gian t\u00e1c d\u1ee5ng. Metformin g\u1eafn k\u1ebft kh\u00f4ng \u0111\u00e1ng k\u1ec3 v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng v\u00e0 v\u00ec v\u1eady c\u00f3 th\u1ec3 \u00edt t\u01b0\u01a1ng t\u00e1c h\u01a1n v\u1edbi c\u00e1c thu\u1ed1c c\u00f3 \u00e1i l\u1ef1c cao v\u1edbi protein nh\u01b0 salicylate, sulfonamide, chloramphenicol v\u00e0 probenecid, so v\u1edbi sulfonylur\u00ea, ch\u1ea5t g\u1eafn k\u1ebft r\u1ed9ng r\u00e3i v\u1edbi protein huy\u1ebft thanh.<\/p>\n<p><em>CHUY\u1ec2N H\u00d3A<\/em><\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Chuy\u1ec3n h\u00f3a c\u1ee7a saxagliptin ch\u1ee7 y\u1ebfu x\u1ea3y ra qua h\u1ec7 cytochrome P450 3A4\/5 (CYP3A4\/5). Ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a saxagliptin c\u0169ng c\u00f3 t\u00e1c d\u1ee5ng \u1ee9c ch\u1ebf DPP-4 v\u00e0 c\u00f3 ho\u1ea1t t\u00ednh b\u1eb1ng \u00bd so v\u1edbi saxagliptin. V\u00ec th\u1ebf, nh\u1eefng thu\u1ed1c \u1ee9c ch\u1ebf v\u00e0 c\u1ea3m \u1ee9ng m\u1ea1nh CYP3A4\/5 s\u1ebd l\u00e0m thay \u0111\u1ed5i d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 (xem ph\u1ea7n T\u01b0\u01a1ng t\u00e1c).<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>C\u00e1c nghi\u00ean c\u1ee9u \u0111\u01a1n tr\u1ecb li\u1ec7u qua \u0111\u01b0\u1eddng t\u0129nh m\u1ea1ch \u1edf nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh cho th\u1ea5y metformin \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft kh\u00f4ng \u0111\u1ed5i qua n\u01b0\u1edbc ti\u1ec3u v\u00e0 kh\u00f4ng chuy\u1ec3n h\u00f3a qua gan (kh\u00f4ng c\u00f3 ch\u1ea5t chuy\u1ec3n h\u00f3a n\u00e0o \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y \u1edf ng\u01b0\u1eddi) ho\u1eb7c b\u00e0i ti\u1ebft qua m\u1eadt.<\/p>\n<p>C\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 chuy\u1ec3n h\u00f3a c\u1ee7a vi\u00ean n\u00e9n ph\u00f3ng th\u00edch k\u00e9o d\u00e0i metformin ch\u01b0a \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n.<\/p>\n<p><em>TH\u1ea2I TR\u1eea<\/em><\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Saxagliptin \u0111\u01b0\u1ee3c \u0111\u00e0o th\u1ea3i qua c\u1ea3 2 \u0111\u01b0\u1eddng: th\u1eadn v\u00e0 gan. Sau khi u\u1ed1ng m\u1ed9t li\u1ec1u \u0111\u01a1n 14C-saxagliptin 50 mg th\u00ec saxagliptin nguy\u00ean v\u1eb9n, d\u1ea1ng chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh v\u00e0 t\u1ed5ng c\u00e1c h\u1ee3p ch\u1ea5t c\u00f3 ho\u1ea1t t\u00ednh ph\u00f3ng x\u1ea1 \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft qua n\u01b0\u1edbc ti\u1ec3u v\u1edbi t\u1ef7 l\u1ec7 l\u1ea7n l\u01b0\u1ee3t 24%, 36% v\u00e0 75% li\u1ec1u s\u1eed d\u1ee5ng. \u0110\u1ed9 thanh th\u1ea3i trung b\u00ecnh qua th\u1eadn c\u1ee7a saxagliptin (~230 mL\/ph\u00fat) cao h\u01a1n so v\u1edbi \u0111\u1ed9 l\u1ecdc c\u1ea7u th\u1eadn \u01b0\u1edbc t\u00ednh trung b\u00ecnh (eGFR) (~120 mL\/ph\u00fat), cho th\u1ea5y c\u00f3 nh\u1eefng c\u01a1 ch\u1ebf b\u00e0i ti\u1ebft ch\u1ee7 \u0111\u1ed9ng \u1edf th\u1eadn. Kho\u1ea3ng 22% ch\u1ea5t c\u00f3 ho\u1ea1t t\u00ednh ph\u00f3ng x\u1ea1 hi\u1ec7n di\u1ec7n trong ph\u00e2n, ch\u1ee9ng t\u1ecf c\u00f3 1 ph\u1ea7n saxagliptin b\u00e0i ti\u1ebft qua m\u1eadt v\u00e0\/hay m\u1ed9t ph\u1ea7n kh\u00f4ng \u0111\u01b0\u1ee3c h\u1ea5p thu qua \u0111\u01b0\u1eddng ti\u00eau h\u00f3a. Sau khi u\u1ed1ng 1 li\u1ec1u \u0111\u01a1n saxagliptin 5 mg tr\u00ean \u0111\u1ed1i t\u01b0\u1ee3ng kh\u1ecfe m\u1ea1nh, th\u1eddi gian b\u00e1n th\u1ea3i trung b\u00ecnh (T1\/2) c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh trong huy\u1ebft t\u01b0\u01a1ng t\u01b0\u01a1ng \u1ee9ng l\u1ea7n l\u01b0\u1ee3t l\u00e0 2,5 gi\u1edd v\u00e0 3,1 gi\u1edd.<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>\u0110\u1ed9 thanh th\u1ea3i th\u1eadn cao h\u01a1n \u0111\u1ed9 thanh th\u1ea3i creatinine kho\u1ea3ng 3,5 l\u1ea7n, \u0111i\u1ec1u n\u00e0y cho th\u1ea5y s\u1ef1 b\u00e0i ti\u1ebft \u1edf \u1ed1ng th\u1eadn l\u00e0 \u0111\u01b0\u1eddng th\u1ea3i tr\u1eeb ch\u00ednh metformin. Sau khi u\u1ed1ng, kho\u1ea3ng 90% thu\u1ed1c h\u1ea5p thu \u0111\u01b0\u1ee3c th\u1ea3i tr\u1eeb qua th\u1eadn trong v\u00f2ng 24 gi\u1edd \u0111\u1ea7u, v\u1edbi th\u1eddi gian b\u00e1n th\u1ea3i trong huy\u1ebft t\u01b0\u01a1ng kho\u1ea3ng 6,2 gi\u1edd. Trong m\u00e1u, th\u1eddi gian b\u00e1n th\u1ea3i kho\u1ea3ng 17,6 gi\u1edd, cho th\u1ea5y h\u1ed3ng c\u1ea7u c\u00f3 th\u1ec3 l\u00e0 m\u1ed9t ng\u0103n nh\u1eadn ph\u00e2n ph\u1ed1i thu\u1ed1c.<\/p>\n<p><em>C\u00c1C NH\u00d3M D\u00c2N S\u1ed0 \u0110\u1eb6C BI\u1ec6T<\/em><\/p>\n<p><em>Suy th\u1eadn<\/em><\/p>\n<p>KOMBOGLYZE XR<\/p>\n<p>\u1ede b\u1ec7nh nh\u00e2n b\u1ecb suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn (d\u1ef1a v\u00e0o \u0111\u1ed9 thanh th\u1ea3i creatinine \u0111o \u0111\u01b0\u1ee3c), th\u1eddi gian b\u00e1n th\u1ea3i trong m\u00e1u v\u00e0 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a metformin k\u00e9o d\u00e0i v\u00e0 \u0111\u1ed9 thanh th\u1ea3i th\u1eadn gi\u1ea3m t\u1ef7 l\u1ec7 v\u1edbi m\u1ee9c gi\u1ea3m c\u1ee7a \u0111\u1ed9 thanh th\u1ea3i creatinine. S\u1eed d\u1ee5ng metformin \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn l\u00e0m t\u0103ng nguy c\u01a1 nhi\u1ec5m toan ax\u00edt lactic. Do KOMBOGLYZE XR c\u00f3 ch\u1ee9a metformin, KOMBOGLYZE XR ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn (xem ph\u1ea7n Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v\u00e0 C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Suy gan<\/em><\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u1edf b\u1ec7nh nh\u00e2n suy gan. S\u1eed d\u1ee5ng metformin \u1edf b\u1ec7nh nh\u00e2n suy gan c\u00f3 li\u00ean quan \u0111\u1ebfn v\u00e0i ca b\u1ecb nhi\u1ec5m toan ax\u00edt lactic. Do KOMBOGLYZE XR c\u00f3 ch\u1ee9a metformin, kh\u00f4ng khuy\u1ebfn c\u00e1o d\u00f9ng KOMBOGLYZE XR \u1edf b\u1ec7nh nh\u00e2n suy gan (xem ph\u1ea7n C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Ch\u1ec9 s\u1ed1 kh\u1ed1i c\u01a1 th\u1ec3<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Kh\u00f4ng c\u1ea7n \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u l\u01b0\u1ee3ng d\u1ef1a tr\u00ean ch\u1ec9 s\u1ed1 kh\u1ed1i c\u01a1 th\u1ec3 (BMI) v\u00ec ch\u1ec9 s\u1ed1 n\u00e0y kh\u00f4ng ph\u1ea3i l\u00e0 \u0111\u1ed3ng bi\u1ebfn s\u1ed1 c\u00f3 \u00fd ngh\u0129a \u0111\u1ebfn \u0111\u1ed9 thanh th\u1ea3i bi\u1ec3u ki\u1ebfn c\u1ee7a saxagliptin ho\u1eb7c ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3, tr\u00ean d\u00e2n s\u1ed1 \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch v\u1ec1 m\u1eb7t d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc.<\/p>\n<p><em>Gi\u1edbi t\u00ednh<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Kh\u00f4ng c\u1ea7n \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u l\u01b0\u1ee3ng theo gi\u1edbi t\u00ednh. Kh\u00f4ng c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin gi\u1eefa nam gi\u1edbi v\u00e0 n\u1eef gi\u1edbi. N\u1eef gi\u1edbi c\u00f3 n\u1ed3ng \u0111\u1ed9 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh trong huy\u1ebft t\u01b0\u01a1ng cao h\u01a1n kho\u1ea3ng 25% so v\u1edbi nam gi\u1edbi nh\u01b0ng s\u1ef1 kh\u00e1c bi\u1ec7t n\u00e0y \u00edt c\u00f3 \u00fd ngh\u0129a tr\u00ean l\u00e2m s\u00e0ng. Gi\u1edbi t\u00ednh kh\u00f4ng ph\u1ea3i l\u00e0 \u0111\u1ed3ng bi\u1ebfn s\u1ed1 c\u00f3 \u00fd ngh\u0129a tr\u00ean \u0111\u1ed9 thanh th\u1ea3i bi\u1ec3u ki\u1ebfn c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 tr\u00ean d\u00e2n s\u1ed1 \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch v\u1ec1 m\u1eb7t d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc.<\/p>\n<p>Metformin hydroclorid<\/p>\n<p>C\u00e1c th\u00f4ng s\u1ed1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin gi\u1eefa c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng kh\u1ecfe m\u1ea1nh v\u00e0 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 kh\u00e1c bi\u1ec7t kh\u00f4ng c\u00f3 \u00fd ngh\u0129a khi ph\u00e2n t\u00edch theo gi\u1edbi t\u00ednh (nam=19, n\u1eef=16). T\u01b0\u01a1ng t\u1ef1, trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng tr\u00ean b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, hi\u1ec7u qu\u1ea3 ch\u1ed1ng t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft c\u1ee7a metformin t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau gi\u1eefa nam v\u00e0 n\u1eef.<\/p>\n<p><em>B\u1ec7nh nh\u00e2n cao tu\u1ed5i<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Kh\u00f4ng c\u1ea7n \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u l\u01b0\u1ee3ng theo \u0111\u1ed9 tu\u1ed5i. B\u1ec7nh nh\u00e2n cao tu\u1ed5i (65-80 tu\u1ed5i) c\u00f3 trung b\u00ecnh nh\u00e2n Cmax v\u00e0 AUC c\u1ee7a saxagliptin cao h\u01a1n t\u01b0\u01a1ng \u1ee9ng kho\u1ea3ng 23% v\u00e0 59% so v\u1edbi Cmax v\u00e0 AUC c\u1ee7a b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i (18-40 tu\u1ed5i). S\u1ef1 kh\u00e1c nhau v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh gi\u1eefa b\u1ec7nh nh\u00e2n cao tu\u1ed5i v\u00e0 b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i th\u01b0\u1eddng ph\u1ea3n \u00e1nh s\u1ef1 kh\u00e1c nhau v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin. S\u1ef1 kh\u00e1c nhau v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 gi\u1eefa b\u1ec7nh nh\u00e2n cao tu\u1ed5i v\u00e0 b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i c\u00f3 th\u1ec3 do nhi\u1ec1u y\u1ebfu t\u1ed1 \u1ea3nh h\u01b0\u1edfng, bao g\u1ed3m suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn v\u00e0 kh\u1ea3 n\u0103ng chuy\u1ec3n h\u00f3a khi tu\u1ed5i gia t\u0103ng. \u0110\u1ed9 tu\u1ed5i kh\u00f4ng ph\u1ea3i l\u00e0 \u0111\u1ed3ng bi\u1ebfn s\u1ed1 c\u00f3 \u00fd ngh\u0129a tr\u00ean \u0111\u1ed9 thanh th\u1ea3i bi\u1ec3u ki\u1ebfn c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 tr\u00ean d\u00e2n s\u1ed1 \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch v\u1ec1 m\u1eb7t d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc.<\/p>\n<p>Metformin hydroclorid<\/p>\n<p>C\u00f3 \u00edt d\u1eef li\u1ec7u t\u1eeb c\u00e1c nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u00f3 \u0111\u1ed1i ch\u1ee9ng s\u1eed d\u1ee5ng metformin tr\u00ean c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng ng\u01b0\u1eddi cao tu\u1ed5i kh\u1ecfe m\u1ea1nh cho th\u1ea5y \u0111\u1ed9 thanh th\u1ea3i huy\u1ebft t\u01b0\u01a1ng to\u00e0n ph\u1ea7n c\u1ee7a metformin gi\u1ea3m \u0111i, th\u1eddi gian b\u00e1n h\u1ee7y k\u00e9o d\u00e0i v\u00e0 Cmax gia t\u0103ng, so v\u1edbi nh\u1eefng c\u00e1 th\u1ec3 tr\u1ebb tu\u1ed5i kh\u1ecfe m\u1ea1nh. Nh\u1eefng d\u1eef li\u1ec7u n\u00e0y cho th\u1ea5y thay \u0111\u1ed5i d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin theo tu\u1ed5i l\u00e0 do thay \u0111\u1ed5i ch\u1ee9c n\u0103ng th\u1eadn.<\/p>\n<p>Kh\u00f4ng n\u00ean kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng KOMBOGLYZE XR cho m\u1ecdi l\u1ee9a tu\u1ed5i tr\u1eeb khi x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c \u0111\u1ed9 thanh th\u1ea3i creatinine cho th\u1ea5y ch\u1ee9c n\u0103ng th\u1eadn b\u00ecnh th\u01b0\u1eddng (xem C\u1ea3nh b\u00e1o).<\/p>\n<p><em>Ch\u1ee7ng t\u1ed9c v\u00e0 s\u1eafc t\u1ed9c<\/em><\/p>\n<p>Saxagliptin<\/p>\n<p>Kh\u00f4ng c\u1ea7n \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u l\u01b0\u1ee3ng theo ch\u1ee7ng t\u1ed9c. Ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc so s\u00e1nh v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 tr\u00ean 309 \u0111\u1ed1i t\u01b0\u1ee3ng da tr\u1eafng v\u1edbi 105 \u0111\u1ed1i t\u01b0\u1ee3ng kh\u00f4ng thu\u1ed9c ch\u1ee7ng t\u1ed9c da tr\u1eafng (g\u1ed3m 6 ch\u1ee7ng t\u1ed9c kh\u00e1c nhau) \u0111\u00e3 kh\u00f4ng cho th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh gi\u1eefa 2 nh\u00f3m n\u00e0y.<\/p>\n<p>Metformin hydroclorid<\/p>\n<p>Ch\u01b0a c\u00f3 nghi\u00ean c\u1ee9u v\u1ec1 c\u00e1c th\u00f4ng s\u1ed1 \u0111\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a metformin theo ch\u1ee7ng t\u1ed9c. Trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ed1i ch\u1ee9ng c\u1ee7a metformin \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, hi\u1ec7u qu\u1ea3 ch\u1ed1ng t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c so s\u00e1nh \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n da tr\u1eafng (n=249), da \u0111en (n=51) v\u00e0 ng\u01b0\u1eddi g\u1ed1c T\u00e2y Ban Nha (n=24).<\/p>\n<p><em>C\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 t\u01b0\u01a1ng t\u00e1c thu\u1ed1c<\/em><\/p>\n<p>Ch\u01b0a th\u1ef1c hi\u1ec7n c\u00e1c nghi\u00ean c\u1ee9u t\u01b0\u01a1ng t\u00e1c thu\u1ed1c v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u0111\u1eb7c bi\u1ec7t v\u1edbi KOMBOGLYZE XR, d\u00f9 nh\u1eefng nghi\u00ean c\u1ee9u nh\u01b0 v\u1eady \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n v\u1edbi t\u1eebng th\u00e0nh ph\u1ea7n thu\u1ed1c saxagliptin v\u00e0 metformin.<\/p>\n<p><em>\u0110\u00e1nh gi\u00e1 t\u01b0\u01a1ng t\u00e1c thu\u1ed1c in vitro<\/em><\/p>\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u in vitro, saxagliptin v\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh c\u1ee7a n\u00f3 kh\u00f4ng \u1ee9c ch\u1ebf CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, ho\u1eb7c 3A4, c\u0169ng kh\u00f4ng g\u00e2y c\u1ea3m \u1ee9ng CYP1A2, 2B6, 2C9, ho\u1eb7c 3A4. V\u00ec th\u1ebf saxagliptin kh\u00f4ng l\u00e0m thay \u0111\u1ed5i s\u1ef1 thanh th\u1ea3i qua chuy\u1ec3n h\u00f3a c\u1ee7a c\u00e1c thu\u1ed1c \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a qua c\u00e1c enzyme tr\u00ean khi s\u1eed d\u1ee5ng c\u00f9ng l\u00fac. Saxagliptin l\u00e0 1 c\u01a1 ch\u1ea5t c\u1ee7a P-glycoprotein (P-gp) nh\u01b0ng kh\u00f4ng g\u00e2y \u1ee9c ch\u1ebf c\u0169ng nh\u01b0 c\u1ea3m \u1ee9ng P-gp.<\/p>\n<p><em>\u0110\u00e1nh gi\u00e1 t\u01b0\u01a1ng t\u00e1c thu\u1ed1c in vivo<\/em><\/p>\n<p>&#8211; xem B\u1ea3ng 1, B\u1ea3ng 2, B\u1ea3ng 3 &amp; B\u1ea3ng 4.<\/p>\n<p><em>B\u1ea3ng 1: T\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c d\u00f9ng chung l\u00ean n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a Saxagliptin v\u00e0 5-hydroxy Saxagliptin<\/em><\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\"><strong>Thu\u1ed1c d\u00f9ng chung<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a thu\u1ed1c d\u00f9ng chung*<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a<br \/>\nSaxagliptin*<\/strong><\/td>\n<td colspan=\"3\"><strong>T\u1ec9 s\u1ed1 trung b\u00ecnh nh\u00e2n (t\u1ec9 s\u1ed1 c\u00f3 thu\u1ed1c d\u00f9ng chung\/kh\u00f4ng c\u00f3 thu\u1ed1c d\u00f9ng chung)<br \/>\nKh\u00f4ng \u1ea3nh h\u01b0\u1edfng 1.00<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>.<\/strong><\/td>\n<td><strong>AUC\u2191<\/strong><\/td>\n<td><strong>C<sub>max<\/sub><\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"6\"><strong>Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u \u0111\u1ed1i v\u1edbi c\u00e1c thu\u1ed1c:<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Metformin<\/td>\n<td>1000mg<\/td>\n<td>100mg<\/td>\n<td>Saxagliptin<br \/>\n5-hydroxy Saxagliptin<\/td>\n<td>0.98<\/p>\n<p>0.99<\/td>\n<td>0.79<\/p>\n<p>0.88<\/td>\n<\/tr>\n<tr>\n<td>Glyburide<\/td>\n<td>5mg<\/td>\n<td>10mg<\/td>\n<td>Saxagliptin<br \/>\n5-hydroxy Saxagliptin<\/td>\n<td>0.98<\/p>\n<p>ND<\/td>\n<td>1.08<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Pioglitazone<sup>#<\/sup><\/td>\n<td>45mg 1 l\u1ea7n\/ng\u00e0y x 10 ng\u00e0y<\/td>\n<td>10mg 1 l\u1ea7n\/ng\u00e0y<br \/>\nx 5 ng\u00e0y<\/td>\n<td>Saxagliptin<br \/>\n5-hydroxy Saxagliptin<\/td>\n<td>1,11<\/p>\n<p>ND<\/td>\n<td>1,11<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Digoxin<\/td>\n<td>0.25mg m\u1ed7i 6 gi\u1edd ng\u00e0y \u0111\u1ea7u ti\u00ean, sau \u0111\u00f3 m\u1ed7i 12 gi\u1edd ng\u00e0y th\u1ee9 2, sau \u0111\u00f3 1 l\u1ea7n\/ng\u00e0y x 5 ng\u00e0y<\/td>\n<td>10mg 1 l\u1ea7n\/ng\u00e0y x7 ng\u00e0y<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>1.05<\/p>\n<p>1.06<\/td>\n<td>0.99<\/p>\n<p>1,02<\/td>\n<\/tr>\n<tr>\n<td>Simvastatin<\/td>\n<td>40mg 1 l\u1ea7n\/ng\u00e0y x 8 ng\u00e0y<\/td>\n<td>10mg<br \/>\n1 l\u1ea7n\/ng\u00e0y<br \/>\nx4 ng\u00e0y<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>1.12<\/p>\n<p>1.02<\/td>\n<td>1.21<\/p>\n<p>1.08<\/td>\n<\/tr>\n<tr>\n<td>Diltiazem<\/td>\n<td>360mg k\u00e9o d\u00e0i 1 l\u1ea7n\/ng\u00e0y x 9 ng\u00e0y<\/td>\n<td>10mg<\/td>\n<td>Saxagliptin<br \/>\n5-hydroxy Saxagliptin<\/td>\n<td>2.09<\/p>\n<p>0.66<\/td>\n<td>1.63 0.57<\/td>\n<\/tr>\n<tr>\n<td>Rifampin<sup>$<\/sup><\/td>\n<td>600mg 1 l\u1ea7n\/ng\u00e0y x 6 ng\u00e0y<\/td>\n<td>5mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>0.24<\/p>\n<p>1.03<\/td>\n<td>0.47<\/p>\n<p>1.39<\/td>\n<\/tr>\n<tr>\n<td>Omeprazole<\/td>\n<td>40mg 1 l\u1ea7n\/ng\u00e0y x 5 ng\u00e0y<\/td>\n<td>10mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>1.13<\/p>\n<p>ND<\/td>\n<td>0.98<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Aluminum<br \/>\nhydroxide +<br \/>\nmagnesium hydroxide +<br \/>\nsimethicone<\/td>\n<td>Aluminum hydroxide: 2400mg<\/p>\n<p>Magnesium hydroxide: 2400mg<\/p>\n<p>Simethicone: 240mg<\/td>\n<td>10mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>0.97<\/p>\n<p>ND<\/td>\n<td>0.74<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Famotidine<\/td>\n<td>40mg<\/td>\n<td>10mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>1.03<\/p>\n<p>ND<\/td>\n<td>1.14<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Ketoconazole<\/td>\n<td>200mg 2 l\u1ea7n\/ng\u00e0y<\/td>\n<td>100mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>2.45<\/p>\n<p>0.12<\/td>\n<td>1.62<\/p>\n<p>0.05<\/td>\n<\/tr>\n<tr>\n<td>Ketoconazole<\/td>\n<td>200mg 2 l\u1ea7n\/ng\u00e0y x 7 ng\u00e0y<\/td>\n<td>20mg<\/td>\n<td>Saxagliptin<\/p>\n<p>5-hydroxy Saxagliptin<\/td>\n<td>3.67<\/p>\n<p>ND<\/td>\n<td>2.44<\/p>\n<p>ND<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0110\u01a1n tr\u1ecb li\u1ec7u tr\u1eeb khi c\u00f3 l\u01b0u \u00fd kh\u00e1c.<\/p>\n<p>\u2191AUC = AUC (INF) \u0111\u1ed1i v\u1edbi thu\u1ed1c d\u00f9ng \u0111\u01a1n li\u1ec1u v\u00e0 AUC = AUC (TAU) \u0111\u1ed1i v\u1edbi thu\u1ed1c d\u00f9ng \u0111a li\u1ec1u.<\/p>\n<p>K\u1ebft qu\u1ea3 kh\u00f4ng bao g\u1ed3m m\u1ed9t \u0111\u1ed1i t\u01b0\u1ee3ng.<\/p>\n<p>Ho\u1ea1t t\u00ednh \u1ee9c ch\u1ebf dipeptidyl peptidase-4 (DPP4) huy\u1ebft t\u01b0\u01a1ng trong kho\u1ea3ng li\u1ec1u 24 gi\u1edd kh\u00f4ng b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi Rifampin.<\/p>\n<p>ND = ch\u01b0a x\u00e1c \u0111\u1ecbnh; QD = 1 l\u1ea7n\/ng\u00e0y; q6h = m\u1ed7i 6 gi\u1edd; q12h = m\u1ed7i 12 gi\u1edd; BID = 2 l\u1ea7n\/ng\u00e0y; LA = t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i.<\/p>\n<p><em>B\u1ea3ng 2: T\u00e1c \u0111\u1ed9ng c\u1ee7a Saxagliptin \u0111\u1ebfn n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a thu\u1ed1c d\u00f9ng chung<\/em><\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\"><strong>Thu\u1ed1c d\u00f9ng chung<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a thu\u1ed1c d\u00f9ng chung*<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a<br \/>\nSaxagliptin*<\/strong><\/td>\n<td colspan=\"3\"><strong>T\u1ec9 s\u1ed1 trung b\u00ecnh nh\u00e2n (t\u1ec9 s\u1ed1 c\u00f3 thu\u1ed1c d\u00f9ng chung\/kh\u00f4ng c\u00f3 thu\u1ed1c d\u00f9ng chung)<\/strong><\/p>\n<p><strong>Kh\u00f4ng \u1ea3nh h\u01b0\u1edfng = 1.00<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>.<\/strong><\/td>\n<td><strong>AUC\u2191<\/strong><\/td>\n<td><strong>C<sub>max<\/sub><\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"6\"><strong>Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u \u0111\u1ed1i v\u1edbi nh\u1eefng thu\u1ed1c sau:<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Metformin<\/td>\n<td>1000mg<\/td>\n<td>100mg<\/td>\n<td>Metformin<\/td>\n<td>1.20<\/td>\n<td>1.09<\/td>\n<\/tr>\n<tr>\n<td>Glyburide<\/td>\n<td>5mg<\/td>\n<td>10mg<\/td>\n<td>Glyburide<\/td>\n<td>1.06<\/td>\n<td>1.16<\/td>\n<\/tr>\n<tr>\n<td>Pioglitazone<sup>#<\/sup><\/td>\n<td>45mg 1 l\u1ea7n\/ng\u00e0y x 10 ng\u00e0y<\/td>\n<td>10mg<br \/>\n1 l\u1ea7n\/ng\u00e0y<br \/>\nx 5 ng\u00e0y<\/td>\n<td>Pioglitazone<\/p>\n<p>hydroxy-pioglitazone<\/td>\n<td>1.08<\/p>\n<p>ND<\/td>\n<td>1.14<\/p>\n<p>ND<\/td>\n<\/tr>\n<tr>\n<td>Digoxin<\/td>\n<td>0.25mg m\u1ed7i 6gi\u1edd ng\u00e0y \u0111\u1ea7u ti\u00ean, sau \u0111\u00f3 m\u1ed7i 12 gi\u1edd ng\u00e0y th\u1ee9 2, sau \u0111\u00f3 1 l\u1ea7n\/ng\u00e0y x 5 ng\u00e0y<\/td>\n<td>10mg<br \/>\n1 l\u1ea7n\/ng\u00e0y<br \/>\nx 7 ng\u00e0y<\/td>\n<td>Digoxin<\/td>\n<td>1.06<\/td>\n<td>1.09<\/td>\n<\/tr>\n<tr>\n<td>Simvastatin<\/td>\n<td>40mg 1 l\u1ea7n\/ng\u00e0y x 8 ng\u00e0y<\/td>\n<td>10mg<\/p>\n<p>1 l\u1ea7n\/ng\u00e0y<br \/>\nx 4 ng\u00e0y<\/td>\n<td>Simvastatin<br \/>\nAx\u00edt simvastatin<\/td>\n<td>1.04<\/p>\n<p>1.16<\/td>\n<td>0.88<\/p>\n<p>1.00<\/td>\n<\/tr>\n<tr>\n<td>Diltiazem<\/td>\n<td>360mg k\u00e9o d\u00e0i 1 l\u1ea7n\/ng\u00e0y x 9 ng\u00e0y<\/td>\n<td>10mg<\/td>\n<td>Diltiazem<\/td>\n<td>1.10<\/td>\n<td>1.16<\/td>\n<\/tr>\n<tr>\n<td>Ketoconazole<\/td>\n<td>200mg 2 l\u1ea7n\/ng\u00e0y x 9 ng\u00e0y<\/td>\n<td>100mg<\/td>\n<td>Ketoconazole<\/td>\n<td>0.87<\/td>\n<td>0.84<\/td>\n<\/tr>\n<tr>\n<td>Ethinyl estradiol v\u00e0<br \/>\nNorgestimate<\/td>\n<td>Ethinyl estradiol 0.035mg v\u00e0<br \/>\nNorgestimate 0.250mg x 21 ng\u00e0y<\/td>\n<td>5mg<br \/>\n1 l\u1ea7n\/ng\u00e0y<br \/>\nx 21 ng\u00e0y<\/td>\n<td>Ethinyl estradiol<br \/>\nNorelgestromin<br \/>\nNorgestrel<\/td>\n<td>1.07<\/p>\n<p>1.10<\/p>\n<p>1.13<\/td>\n<td>0.98<\/p>\n<p>1.09<\/p>\n<p>1.17<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0110\u01a1n tr\u1ecb li\u1ec7u tr\u1eeb khi c\u00f3 l\u01b0u \u00fd kh\u00e1c.<\/p>\n<p>AUC = AUC (INF) \u0111\u1ed1i v\u1edbi thu\u1ed1c d\u00f9ng \u0111\u01a1n li\u1ec1u v\u00e0 AUC = AUC (TAU) \u0111\u1ed1i v\u1edbi thu\u1ed1c d\u00f9ng \u0111a li\u1ec1u.<\/p>\n<p>K\u1ebft qu\u1ea3 bao g\u1ed3m t\u1ea5t c\u1ea3 c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n.<\/p>\n<p>ND=ch\u01b0a x\u00e1c \u0111\u1ecbnh; QD=1 l\u1ea7n\/ng\u00e0y; q6h=m\u1ed7i 6 gi\u1edd; q12h= m\u1ed7i 12 gi\u1edd; BID=2 l\u1ea7n\/ng\u00e0y; LA=t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i.<\/p>\n<p><em>B\u1ea3ng 3: T\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c d\u00f9ng chung \u0111\u1ebfn n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a Metformin trong huy\u1ebft t\u01b0\u01a1ng.<\/em><\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\"><strong>Thu\u1ed1c d\u00f9ng chung<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a thu\u1ed1c d\u00f9ng chung*<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a<br \/>\nMetformin*<\/strong><\/td>\n<td colspan=\"3\"><strong>T\u1ec9 s\u1ed1 trung b\u00ecnh nh\u00e2n (t\u1ec9 s\u1ed1 c\u00f3 thu\u1ed1c d\u00f9ng chung\/kh\u00f4ng c\u00f3 thu\u1ed1c d\u00f9ng chung)<\/strong><\/p>\n<p><strong>Kh\u00f4ng \u1ea3nh h\u01b0\u1edfng = 1.00<\/strong><\/td>\n<\/tr>\n<tr>\n<td>.<\/td>\n<td><strong>AUC\u2191<\/strong><\/td>\n<td><strong>C<sub>max<\/sub><\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"7\"><strong>Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u \u0111\u1ed1i v\u1edbi nh\u1eefng thu\u1ed1c sau:<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Glyburide<\/td>\n<td>5mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td>0.91<sup>#<\/sup><\/td>\n<td>0.93<sup>#<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Furosemide<\/td>\n<td>40mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td>1.09<sup>#<\/sup><\/td>\n<td>1.22<sup>#<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Nifedipine<\/td>\n<td>10mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td>1.16<\/td>\n<td>1.21<\/td>\n<\/tr>\n<tr>\n<td>Propranolol<\/td>\n<td>40mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td>0.90<\/td>\n<td>0.94<\/td>\n<\/tr>\n<tr>\n<td>Ibuprofen<\/td>\n<td>400mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td>1.05#<\/td>\n<td>1.07#<\/td>\n<\/tr>\n<tr>\n<td colspan=\"7\"><strong>Nh\u1eefng thu\u1ed1c cationic th\u1ea3i tr\u1eeb qua b\u00e0i ti\u1ebft c\u1ee7a \u1ed1ng th\u1eadn c\u00f3 th\u1ec3 gi\u1ea3m s\u1ef1 b\u00e0i ti\u1ebft Metformin: th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng.[Xem ph\u1ea7n L\u01b0u \u00fd v\u00e0 th\u1eadn tr\u1ecdng v\u00e0 ph\u1ea7n T\u01b0\u01a1ng t\u00e1c thu\u1ed1c]<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Cimetidine<\/td>\n<td>400mg<\/td>\n<td>850mg<\/td>\n<td>Metformin<\/td>\n<td><\/td>\n<td>1.61<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>* T\u1ea5t c\u1ea3 Metformin v\u00e0 c\u00e1c thu\u1ed1c d\u00f9ng chung \u0111\u1ec1u d\u00f9ng \u0111\u01a1n tr\u1ecb li\u1ec7u.<\/p>\n<p>\u2191 AUC = AUC(INF).<\/p>\n<p># T\u1ec9 s\u1ed1 trung b\u00ecnh c\u1ed9ng.<\/p>\n<p>B\u1ea3ng 4: T\u00e1c \u0111\u1ed9ng c\u1ee7a Metformin \u0111\u1ebfn n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a thu\u1ed1c d\u00f9ng chung<\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\"><strong>Thu\u1ed1c d\u00f9ng chung<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a thu\u1ed1c d\u00f9ng chung*<\/strong><\/td>\n<td rowspan=\"2\"><strong>Li\u1ec1u c\u1ee7a<br \/>\nMetformin*<\/strong><\/td>\n<td colspan=\"3\"><strong>T\u1ec9 s\u1ed1 trung b\u00ecnh nh\u00e2n (t\u1ec9 s\u1ed1 c\u00f3 thu\u1ed1c d\u00f9ng chung\/kh\u00f4ng c\u00f3 thu\u1ed1c d\u00f9ng chung)<\/strong><\/p>\n<p><strong>Kh\u00f4ng \u1ea3nh h\u01b0\u1edfng 1.00<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>.<\/strong><\/td>\n<td><strong>AUC\u2191<\/strong><\/td>\n<td><strong>C<sub>max<\/sub><\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"6\">Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u \u0111\u1ed1i v\u1edbi nh\u1eefng thu\u1ed1c sau:<\/td>\n<\/tr>\n<tr>\n<td>Glyburide<\/td>\n<td>5mg<\/td>\n<td>850mg<\/td>\n<td>Glyburide<\/td>\n<td>0.78<sup>#<\/sup><\/td>\n<td>0.63<sup>#<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Furosemide<\/td>\n<td>40mg<\/td>\n<td>850mg<\/td>\n<td>Furosemide<\/td>\n<td>0.87<sup>#<\/sup><\/td>\n<td>0.69<sup>#<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Nifedipine<\/td>\n<td>10mg<\/td>\n<td>850mg<\/td>\n<td>Nifedipine<\/td>\n<td>1.10<sup>$<\/sup><\/td>\n<td>1.08<\/td>\n<\/tr>\n<tr>\n<td>Propranolol<\/td>\n<td>40mg<\/td>\n<td>850mg<\/td>\n<td>Propranolol<\/td>\n<td>1.01<sup>$<\/sup><\/td>\n<td>1.02<\/td>\n<\/tr>\n<tr>\n<td>Ibuprofen<\/td>\n<td>400mg<\/td>\n<td>850mg<\/td>\n<td>Ibuprofen<\/td>\n<td>0.97<sup>\u00a5<\/sup><\/td>\n<td>1.01<sup>\u00a5<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Cimetidine<\/td>\n<td>400mg<\/td>\n<td>850mg<\/td>\n<td>Cimetidine<\/td>\n<td>0.95<sup>$<\/sup><\/td>\n<td>1.01<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>* T\u1ea5t c\u1ea3 Metformin v\u00e0 c\u00e1c thu\u1ed1c d\u00f9ng chung \u0111\u1ec1u d\u00f9ng \u0111\u01a1n tr\u1ecb li\u1ec7u.<\/p>\n<p>\u2191AUC = AUC(INF) tr\u1eeb l\u01b0u \u00fd kh\u00e1c.<\/p>\n<p># T\u1ec9 s\u1ed1 trung b\u00ecnh c\u1ed9ng, kh\u00e1c bi\u1ec7t tr\u1ecb s\u1ed1 p &lt; 0.05.<\/p>\n<p>$ AUC(0-24 gi\u1edd) \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"53-hieu-qua-lam-sang\"><\/span>5.3. Hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>C\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n l\u00e2m s\u00e0ng th\u1ef1c hi\u1ec7n tr\u00ean KOMBOGLYZE XR nh\u1eb1m x\u00e1c \u0111\u1ecbnh hi\u1ec7u qu\u1ea3 gi\u1ea3m ch\u1ec9 s\u1ed1 hemoglobin A1c (HbA1c) ch\u01b0a \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh. T\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u1ee7a KOMBOGLYZE XR v\u1edbi s\u1eed d\u1ee5ng chung saxagliptin v\u00e0 vi\u00ean metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh; tuy nhi\u00ean, c\u00e1c nghi\u00ean c\u1ee9u sinh kh\u1ea3 d\u1ee5ng li\u00ean quan gi\u1eefa KOMBOGLYZE XR v\u1edbi s\u1eed d\u1ee5ng chung saxagliptin v\u00e0 vi\u00ean metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi ch\u01b0a \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh. Vi\u00ean metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i v\u00e0 vi\u00ean metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi c\u00f3 m\u1ee9c \u0111\u1ed9 h\u1ea5p thu (\u0111o b\u1eb1ng AUC) t\u01b0\u01a1ng t\u1ef1 nhau trong khi n\u1ed3ng \u0111\u1ed9 \u0111\u1ec9nh trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a vi\u00ean ph\u00f3ng th\u00edch k\u00e9o d\u00e0i th\u1ea5p h\u01a1n kho\u1ea3ng 20% so v\u1edbi vi\u00ean ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p><em>C\u1ea3i thi\u1ec7n ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft<\/em><\/p>\n<p>S\u1eed d\u1ee5ng chung saxagliptin v\u1edbi vi\u00ean n\u00e9n ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi metformin hydrochlorid \u0111\u00e3 \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u tr\u00ean ng\u01b0\u1eddi l\u1edbn b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u metformin v\u00e0 tr\u00ean b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3. Trong hai nghi\u00ean c\u1ee9u n\u00e0y, \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin d\u00f9ng bu\u1ed5i s\u00e1ng k\u1ebft h\u1ee3p v\u1edbi vi\u00ean n\u00e9n ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi metformin hydrochlorid \u1edf t\u1ea5t c\u1ea3 c\u00e1c m\u1ee9c li\u1ec1u \u0111\u1ec1u cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng ch\u1ec9 s\u1ed1 HbA1c, \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i (FPG) v\u00e0 \u0111\u01b0\u1eddng huy\u1ebft sau \u0103n 2 gi\u1edd (PPG) sau khi th\u1ef1c hi\u1ec7n nghi\u1ec7m ph\u00e1p dung n\u1ea1p glucose \u0111\u01b0\u1eddng u\u1ed1ng chu\u1ea9n (OGTT) so v\u1edbi nh\u00f3m \u0111\u1ed1i ch\u1ee9ng. Gi\u1ea3m HbA1c \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf t\u1ea5t c\u1ea3 c\u00e1c ph\u00e2n nh\u00f3m bao g\u1ed3m gi\u1edbi t\u00ednh, tu\u1ed5i, ch\u1ee7ng t\u1ed9c v\u00e0 ch\u1ec9 s\u1ed1 kh\u1ed1i c\u01a1 th\u1ec3 (BMI) ban \u0111\u1ea7u.<\/p>\n<p>Trong hai nghi\u00ean c\u1ee9u n\u00e0y, gi\u1ea3m c\u00e2n n\u1eb7ng c\u01a1 th\u1ec3 \u1edf c\u00e1c nh\u00f3m \u0111i\u1ec1u tr\u1ecb saxagliptin k\u1ebft h\u1ee3p v\u1edbi metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi t\u01b0\u01a1ng t\u1ef1 nh\u01b0 \u1edf c\u00e1c nh\u00f3m ch\u1ec9 d\u00f9ng metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi. So v\u1edbi ch\u1ec9 d\u00f9ng metformin \u0111\u01a1n \u0111\u1ed9c, saxagliptin k\u1ebft h\u1ee3p v\u1edbi metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi kh\u00f4ng li\u00ean quan \u0111\u1ebfn c\u00e1c thay \u0111\u1ed5i c\u00f3 \u00fd ngh\u0129a lipid huy\u1ebft thanh l\u00fac \u0111\u00f3i so v\u1edbi m\u1ee9c ban \u0111\u1ea7u.<\/p>\n<p>S\u1eed d\u1ee5ng saxagliptin k\u1ebft h\u1ee3p metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 qua m\u1ed9t nghi\u00ean c\u1ee9u c\u00f3 \u0111\u1ed1i ch\u1ee9ng so s\u00e1nh s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p saxagliptin v\u1edbi glipizide tr\u00ean 858 b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u metformin, m\u1ed9t nghi\u00ean c\u1ee9u c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c tr\u00ean m\u1ed9t ph\u00e2n nh\u00f3m g\u1ed3m 314 b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi insulin k\u1ebft h\u1ee3p metformin \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p b\u1ed5 sung saxagliptin ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c v\u00e0 m\u1ed9t nghi\u00ean c\u1ee9u so s\u00e1nh saxagliptin v\u1edbi gi\u1ea3 d\u01b0\u1ee3c tr\u00ean 257 b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 v\u1edbi metformin v\u00e0 m\u1ed9t thu\u1ed1c nh\u00f3m sulfonylur\u00ea.<\/p>\n<p>Trong th\u1eed nghi\u1ec7m 24 tu\u1ea7n, m\u00f9 \u0111\u00f4i, ng\u1eabu nhi\u00ean, b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi 500 mg, 2 l\u1ea7n\/ng\u00e0y trong \u00edt nh\u1ea5t 8 tu\u1ea7n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb v\u1edbi metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi 500 mg, 2 l\u1ea7n\/ng\u00e0y ho\u1eb7c v\u1edbi metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i 1000 mg, 1 l\u1ea7n\/ng\u00e0y ho\u1eb7c 1500 mg, 1 l\u1ea7n\/ng\u00e0y. Thay \u0111\u1ed5i trung b\u00ecnh ch\u1ec9 s\u1ed1 HbA1c t\u1eeb \u0111\u1ea7u \u0111\u1ebfn tu\u1ea7n 24 l\u00e0 0,1 % (kho\u1ea3ng tin c\u1eady 95% 0%, 0,3%) \u1edf nh\u00f3m d\u00f9ng metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi; 0,3% (kho\u1ea3ng tin c\u1eady 95% 0,1%, 0,4%) \u1edf nh\u00f3m d\u00f9ng metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i 1000 mg, 1 l\u1ea7n\/ng\u00e0y; 0,1% (kho\u1ea3ng tin c\u1eady 95% 0%, 0,3%) \u1edf nh\u00f3m d\u00f9ng metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i 1500 mg, 1 l\u1ea7n\/ng\u00e0y. K\u1ebft qu\u1ea3 c\u1ee7a th\u1eed nghi\u1ec7m n\u00e0y g\u1ee3i \u00fd r\u1eb1ng c\u00e1c b\u1ec7nh nh\u00e2n d\u00f9ng metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi c\u00f3 th\u1ec3 an to\u00e0n chuy\u1ec3n sang metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i 1 l\u1ea7n\/ng\u00e0y \u1edf c\u00f9ng t\u1ed5ng li\u1ec1u h\u00e0ng ng\u00e0y, \u0111\u1ebfn 2000 mg, 1 l\u1ea7n\/ng\u00e0y. N\u00ean theo d\u00f5i ch\u1eb7t ch\u1ebd ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft v\u00e0 \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u th\u00edch h\u1ee3p sau khi chuy\u1ec3n t\u1eeb metformin hydrochlorid ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi sang metformin hydrochlorid ph\u00f3ng th\u00edch k\u00e9o d\u00e0i.<\/p>\n<p><em>Saxagliptin u\u1ed1ng bu\u1ed5i s\u00e1ng v\u00e0 bu\u1ed5i t\u1ed1i<\/em><\/p>\n<p>M\u1ed9t th\u1eed nghi\u1ec7m \u0111\u01a1n tr\u1ecb li\u1ec7u 24 tu\u1ea7n \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 m\u1ed9t kho\u1ea3ng li\u1ec1u c\u1ee7a saxagliptin. B\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (7% \u2264 HbA1c \u2264 10%) b\u01b0\u1edbc v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp 2 tu\u1ea7n, theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang m\u00f9 \u0111\u01a1n, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. T\u1ed5ng s\u1ed1 365 b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng ng\u1eabu nhi\u00ean saxagliptin 2,5 mg m\u1ed7i bu\u1ed5i s\u00e1ng, 5 mg m\u1ed7i bu\u1ed5i s\u00e1ng, 2,5 mg ch\u1ec9nh li\u1ec1u \u0111\u1ebfn 5 mg m\u1ed7i bu\u1ed5i s\u00e1ng, ho\u1eb7c 5 mg m\u1ed7i bu\u1ed5i t\u1ed1i, ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c. B\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u1ea1t m\u1ee9c \u0111\u01b0\u1eddng huy\u1ebft m\u1ee5c ti\u00eau chuy\u00ean bi\u1ec7t trong su\u1ed1t nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng b\u1eb1ng metformin, ph\u1ed1i h\u1ee3p v\u1edbi gi\u1ea3 d\u01b0\u1ee3c ho\u1eb7c saxagliptin; s\u1ed1 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c chia ng\u1eabu nhi\u00ean v\u00e0o t\u1eebng nh\u00f3m \u0111i\u1ec1u tr\u1ecb n\u1eb1m trong kho\u1ea3ng t\u1eeb 71 \u0111\u1ebfn 74.<\/p>\n<p>\u0110i\u1ec1u tr\u1ecb v\u1edbi saxagliptin 5 mg m\u1ed7i bu\u1ed5i s\u00e1ng ho\u1eb7c 5 mg m\u1ed7i bu\u1ed5i t\u1ed1i \u0111\u1ec1u cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ec9 s\u1ed1 HbA1c so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c (ch\u00eanh l\u1ec7ch trung b\u00ecnh so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c t\u01b0\u01a1ng \u1ee9ng l\u00e0 -0,4% v\u00e0 -0,3%).<\/p>\n<p><em>S\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p Saxagliptin v\u1edbi Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi cho b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb<\/em><\/p>\n<p>T\u1ed5ng s\u1ed1 1306 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb tham gia v\u00e0o th\u1eed nghi\u1ec7m 24 tu\u1ea7n, ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 \u0111\u1ed1i ch\u1ee9ng nh\u1eb1m \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi tr\u00ean b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (8% \u2264 HbA1c \u2264 12%) v\u1edbi ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang v\u00e0 luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c. Y\u00eau c\u1ea7u b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc khi tham gia nghi\u00ean c\u1ee9u.<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n ch\u1ecdn b\u1ec7nh \u0111\u01b0\u1ee3c tham gia v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp 1 tu\u1ea7n, m\u00f9 \u0111\u01a1n, theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. B\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c chia ng\u1eabu nhi\u00ean v\u00e0o 1 trong 4 nh\u00f3m: saxagliptin 5 mg + metformin 500 mg ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, saxagliptin 10 mg + metformin 500 mg ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, saxagliptin 10 mg + gi\u1ea3 d\u01b0\u1ee3c, ho\u1eb7c metformin 500 mg ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi + gi\u1ea3 d\u01b0\u1ee3c (li\u1ec1u khuy\u1ebfn c\u00e1o t\u1ed1i \u0111a c\u1ee7a saxagliptin l\u00e0 5mg\/ng\u00e0y; li\u1ec1u 10mg\/ng\u00e0y kh\u00f4ng cho th\u1ea5y hi\u1ec7u qu\u1ea3 h\u01a1n li\u1ec1u 5mg\/ng\u00e0y v\u00e0 li\u1ec1u saxagliptin 10 mg kh\u00f4ng ph\u1ea3i li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t). D\u00f9ng li\u1ec1u saxagliptin 1 l\u1ea7n\/ng\u00e0y. Trong 3 nh\u00f3m \u0111i\u1ec1u tr\u1ecb s\u1eed d\u1ee5ng metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, \u0111i\u1ec1u ch\u1ec9nh t\u0103ng li\u1ec1u metformin m\u1ed7i tu\u1ea7n v\u1edbi m\u1ee9c li\u1ec1u 500 mg\/ng\u00e0y t\u00f9y theo dung n\u1ea1p, \u0111\u1ebfn li\u1ec1u t\u1ed1i \u0111a 2000mg\/ng\u00e0y d\u1ef1a tr\u00ean m\u1ee9c \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i. B\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u1ea1t m\u1ee9c \u0111\u01b0\u1eddng huy\u1ebft m\u1ee5c ti\u00eau chuy\u00ean bi\u1ec7t \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1ed5 sung b\u1eb1ng pioglitazone t\u0103ng c\u01b0\u1eddng.<\/p>\n<p>Saxagliptin 5 mg ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ec9 s\u1ed1 HbA1c, \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i, \u0111\u01b0\u1eddng huy\u1ebft sau \u0103n so v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi (B\u1ea3ng 5).<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1441\" height=\"1487\" class=\"wp-image-55497\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-480.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-480.png 1441w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-480-291x300.png 291w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-480-872x900.png 872w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-480-768x793.png 768w\" sizes=\"auto, (max-width: 1441px) 100vw, 1441px\" \/><\/p>\n<p><em>S\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p Saxagliptin v\u1edbi Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi<\/em><\/p>\n<p>T\u1ed5ng s\u1ed1 743 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 tham gia v\u00e0o th\u1eed nghi\u1ec7m 24 tu\u1ea7n, ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi tr\u00ean b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (7% \u2264 HbA1c \u2264 10%) v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u metformin. \u0110\u1ec3 chu\u1ea9n h\u00f3a \u0111\u1ea7u v\u00e0o, y\u00eau c\u1ea7u b\u1ec7nh nh\u00e2n ph\u1ea3i \u0111ang s\u1eed d\u1ee5ng metformin li\u1ec1u \u1ed5n \u0111\u1ecbnh (1500-2550 mg m\u1ed7i ng\u00e0y) trong \u00edt nh\u1ea5t 8 tu\u1ea7n.<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n ch\u1ecdn b\u1ec7nh \u0111\u01b0\u1ee3c tham gia v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp 2 tu\u1ea7n, m\u00f9 \u0111\u01a1n, theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c; trong giai \u0111o\u1ea1n n\u00e0y b\u1ec7nh nh\u00e2n d\u00f9ng metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi v\u1edbi li\u1ec1u \u0111\u00e3 d\u00f9ng tr\u01b0\u1edbc khi tham gia nghi\u00ean c\u1ee9u, t\u1ed1i \u0111a \u0111\u1ebfn 2500 mg\/ng\u00e0y. Sau giai \u0111o\u1ea1n d\u1eabn nh\u1eadp, nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c d\u00f9ng ng\u1eabu nhi\u00ean saxagliptin 2,5 mg, 5 mg, 10 mg ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c c\u00f9ng v\u1edbi li\u1ec1u metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u0111ang d\u00f9ng (li\u1ec1u khuy\u1ebfn c\u00e1o t\u1ed1i \u0111a c\u1ee7a saxagliptin l\u00e0 5mg\/ng\u00e0y; li\u1ec1u 10mg\/ng\u00e0y kh\u00f4ng cho th\u1ea5y hi\u1ec7u qu\u1ea3 h\u01a1n li\u1ec1u 5mg\/ng\u00e0y v\u00e0 li\u1ec1u saxagliptin 10 mg kh\u00f4ng ph\u1ea3i li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t). B\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u1ea1t m\u1ee9c \u0111\u01b0\u1eddng huy\u1ebft m\u1ee5c ti\u00eau trong su\u1ed1t nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng b\u1eb1ng pioglitazone, b\u1ed5 sung v\u1edbi nh\u1eefng thu\u1ed1c \u0111ang d\u00f9ng trong nghi\u00ean c\u1ee9u. Kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u saxagliptin v\u00e0 meformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p>Saxagliptin 2,5 mg v\u00e0 5 mg ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ec9 s\u1ed1 HbA1c, \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i v\u00e0 \u0111\u01b0\u1eddng huy\u1ebft sau \u0103n so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c ph\u1ed1i h\u1ee3p v\u1edbi metformin (B\u1ea3ng 6). Thay \u0111\u1ed5i trung b\u00ecnh c\u1ee7a ch\u1ec9 s\u1ed1 HbA1c theo th\u1eddi gian v\u00e0 t\u1ea1i l\u00fac k\u1ebft th\u00fac so v\u1edbi ch\u1ec9 s\u1ed1 ban \u0111\u1ea7u \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y \u1edf H\u00ecnh 1. T\u1ef7 l\u1ec7 b\u1ec7nh nh\u00e2n ng\u01b0ng \u0111i\u1ec1u tr\u1ecb do kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft ho\u1eb7c ph\u1ea3i \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng v\u00ec \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n \u0111\u01b0\u1eddng huy\u1ebft \u0111\u01b0\u1ee3c \u0111\u1ecbnh s\u1eb5n l\u00e0 15% \u1edf nh\u00f3m s\u1eed d\u1ee5ng Saxagliptin 2,5 mg ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi, 13% \u1edf nh\u00f3m s\u1eed d\u1ee5ng Saxagliptin 5 mg ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi v\u00e0 27% \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1417\" height=\"1559\" class=\"wp-image-55498\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481.png 1417w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481-273x300.png 273w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481-818x900.png 818w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481-768x845.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-481-1396x1536.png 1396w\" sizes=\"auto, (max-width: 1417px) 100vw, 1417px\" \/><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1442\" height=\"1267\" class=\"wp-image-55499\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-844.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-844.png 1442w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-844-300x264.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-844-1024x900.png 1024w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-844-768x675.png 768w\" sizes=\"auto, (max-width: 1442px) 100vw, 1442px\" \/><\/p>\n<p><em>S\u1eed d\u1ee5ng Saxagliptin k\u1ebft h\u1ee3p v\u1edbi Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi so v\u1edbi Glipizide k\u1ebft h\u1ee3p v\u1edbi Metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi<\/em><\/p>\n<p>Trong th\u1eed nghi\u1ec7m 52 tu\u1ea7n c\u00f3 \u0111\u1ed1i ch\u1ee9ng, t\u1ed5ng s\u1ed1 858 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (6,5% &lt; HbA1c \u2264 10%) v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u0111\u01b0\u1ee3c chia ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i v\u00e0o nh\u00f3m s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi saxagliptin ho\u1eb7c glipizide. Y\u00eau c\u1ea7u b\u1ec7nh nh\u00e2n ph\u1ea3i \u0111ang s\u1eed d\u1ee5ng metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi li\u1ec1u \u1ed5n \u0111\u1ecbnh (t\u1ed1i thi\u1ec3u 1500 mg\/ng\u00e0y) trong \u00edt nh\u1ea5t 8 tu\u1ea7n tr\u01b0\u1edbc khi tham gia nghi\u00ean c\u1ee9u.<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n ch\u1ecdn b\u1ec7nh \u0111\u01b0\u1ee3c tham gia v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp 2 tu\u1ea7n, m\u00f9 \u0111\u01a1n, theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c; trong giai \u0111o\u1ea1n n\u00e0y b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi (1500-3000 mg t\u00f9y theo li\u1ec1u d\u00f9ng tr\u01b0\u1edbc khi tham gia nghi\u00ean c\u1ee9u). Sau giai \u0111o\u1ea1n d\u1eabn nh\u1eadp, b\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c d\u00f9ng ng\u1eabu nhi\u00ean saxagliptin 5 mg ho\u1eb7c glipizide 5 mg ph\u1ed1i h\u1ee3p v\u1edbi li\u1ec1u metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u0111ang d\u00f9ng. B\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng glipizide ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi \u0111\u01b0\u1ee3c t\u0103ng li\u1ec1u glipizide trong 18 tu\u1ea7n \u0111\u1ea7u c\u1ee7a th\u1eed nghi\u1ec7m \u0111\u1ebfn li\u1ec1u t\u1ed1i \u0111a glipizide 20 mg\/ng\u00e0y. T\u0103ng li\u1ec1u d\u1ef1a tr\u00ean \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i m\u1ee5c ti\u00eau \u2264 110 mg\/dL ho\u1eb7c li\u1ec1u glipizide dung n\u1ea1p r\u1ed1i \u0111a. 50% b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi glipizide \u0111\u01b0\u1ee3c t\u0103ng li\u1ec1u \u0111\u1ebfn 20 mg\/ng\u00e0y; 21% b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi glipizide d\u00f9ng li\u1ec1u h\u00e0ng ng\u00e0y cu\u1ed1i c\u00f9ng t\u1eeb 5 mg tr\u1edf xu\u1ed1ng. Li\u1ec1u trung b\u00ecnh h\u00e0ng ng\u00e0y cu\u1ed1i c\u00f9ng c\u1ee7a glipizide l\u00e0 15mg.<\/p>\n<p>Sau 52 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb, saxagliptin v\u00e0 glipizide cho th\u1ea5y m\u1ee9c gi\u1ea3m trung b\u00ecnh HbA1c so v\u1edbi ban \u0111\u1ea7u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau khi s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi (B\u1ea3ng 7). K\u1ebft lu\u1eadn n\u00e0y c\u00f3 th\u1ec3 b\u1ecb gi\u1edbi h\u1ea1n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 HbA1c ban \u0111\u1ea7u c\u00f3 kh\u00e1c bi\u1ec7t v\u1edbi ch\u1ec9 s\u1ed1 trong th\u1eed nghi\u1ec7m (91% b\u1ec7nh nh\u00e2n c\u00f3 HbA1c ban \u0111\u1ea7u &lt; 9%).<\/p>\n<p>T\u1eeb c\u00e2n n\u1eb7ng trung b\u00ecnh ban \u0111\u1ea7u 89kg, b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin gi\u1ea3m 1,1kg c\u00f3 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea so v\u1edbi b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi glipizide t\u0103ng c\u00e2n trung b\u00ecnh 1,1kg (p &lt; 0,0001).<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1441\" height=\"1074\" class=\"wp-image-55500\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-845.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-845.png 1441w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-845-300x224.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-845-1208x900.png 1208w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-845-768x572.png 768w\" sizes=\"auto, (max-width: 1441px) 100vw, 1441px\" \/><\/p>\n<p><em>S\u1eed d\u1ee5ng Saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi Insulin (c\u00f9ng ho\u1eb7c kh\u00f4ng c\u00f9ng v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi)<\/em><\/p>\n<p>T\u1ed5ng s\u1ed1 455 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 tham gia v\u00e0o th\u1eed nghi\u1ec7m 24 tu\u1ea7n, ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 ki\u1ec3m ch\u1ee9ng gi\u1ea3 d\u01b0\u1ee3c nh\u1eb1m \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi insulin tr\u00ean b\u1ec7nh nh\u00e2n kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (7,5% \u2264 HbA1c \u2264 11%) v\u1edbi \u0111\u01a1n tr\u1ecb li\u1ec7u insulin (N=141) ho\u1eb7c insulin ph\u1ed1i h\u1ee3p v\u1edbi metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi li\u1ec1u \u1ed5n \u0111\u1ecbnh (N=314). Y\u00eau c\u1ea7u b\u1ec7nh nh\u00e2n ph\u1ea3i \u0111ang d\u00f9ng insulin li\u1ec1u \u1ed5n \u0111\u1ecbnh (\u2265 30 \u0111\u01a1n v\u1ecb \u0111\u1ebfn \u2264 150 \u0111\u01a1n v\u1ecb\/ng\u00e0y) v\u1edbi m\u1ee9c thay \u0111\u1ed5i \u2264 20% t\u1ed5ng li\u1ec1u h\u1eb1ng ng\u00e0y trong th\u1eddi gian \u2265 8 tu\u1ea7n tr\u01b0\u1edbc khi v\u00e0o s\u00e0ng l\u1ecdc. B\u1ec7nh nh\u00e2n tham gia v\u00e0o nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng insulin t\u00e1c d\u1ee5ng trung b\u00ecnh ho\u1eb7c k\u00e9o d\u00e0i (insulin n\u1ec1n) ho\u1eb7c insulin h\u1ed7n h\u1ee3p pha s\u1eb5n. B\u1ec7nh nh\u00e2n d\u00f9ng insulin t\u00e1c d\u1ee5ng nhanh kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ecdn tr\u1eeb khi insulin t\u00e1c d\u1ee5ng nhanh l\u00e0 m\u1ed9t th\u00e0nh ph\u1ea7n c\u1ee7a insulin h\u1ed7n h\u1ee3p pha s\u1eb5n.<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n ch\u1ecdn b\u1ec7nh tham gia v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp v\u1edbi gi\u1ea3 d\u01b0\u1ee3c 4 tu\u1ea7n, m\u00f9 \u0111\u01a1n, theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang, luy\u1ec7n t\u1eadp th\u1ec3 d\u1ee5c v\u00e0 v\u1eabn s\u1eed d\u1ee5ng insulin (v\u00e0 metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi n\u1ebfu th\u00edch h\u1ee3p) v\u1edbi li\u1ec1u \u0111ang d\u00f9ng tr\u01b0\u1edbc khi tham gia th\u1eed nghi\u1ec7m. Sau giai \u0111o\u1ea1n d\u1eabn nh\u1eadp, b\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi saxagliptin 5 mg ho\u1eb7c v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Li\u1ec1u d\u00f9ng c\u1ee7a thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng \u0111\u01b0\u1ee3c gi\u1eef \u1ed5n \u0111\u1ecbnh, nh\u01b0ng b\u1ec7nh nh\u00e2n c\u1ea7n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng v\u00e0 cho ph\u00e9p \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u insulin n\u1ebfu b\u1ec7nh nh\u00e2n kh\u00f4ng \u0111\u1ea1t m\u1ee9c \u0111\u01b0\u1eddng huy\u1ebft m\u1ee5c ti\u00eau ho\u1eb7c n\u1ebfu ng\u01b0\u1eddi nghi\u00ean c\u1ee9u bi\u1ebft \u0111\u01b0\u1ee3c b\u1ec7nh nh\u00e2n \u0111\u00e3 t\u1ef1 t\u0103ng li\u1ec1u insulin &gt; 20%. D\u1eef li\u1ec7u sau khi \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c ph\u00e2n t\u00edch ch\u00ednh v\u1ec1 hi\u1ec7u qu\u1ea3.<\/p>\n<p>Sau 24 tu\u1ea7n, so v\u1edbi ph\u1ed1i h\u1ee3p gi\u1ea3 d\u01b0\u1ee3c, \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p v\u1edbi saxagliptin 5 mg cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ec9 s\u1ed1 HbA1c v\u00e0 \u0111\u01b0\u1eddng huy\u1ebft sau \u0103n so v\u1edbi ban \u0111\u1ea7u (B\u1ea3ng 8). Khi so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, thay \u0111\u1ed5i trung b\u00ecnh HbA1c \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng saxagliptin 5 mg ph\u1ed1i h\u1ee3p v\u1edbi insulin v\u00e0 saxagliptin 5 mg ph\u1ed1i h\u1ee3p v\u1edbi insulin v\u00e0 metformin ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi l\u00e0 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau (t\u01b0\u01a1ng \u1ee9ng -0,4% v\u00e0 -0,4%). T\u1ef7 l\u1ec7 b\u1ec7nh nh\u00e2n ng\u01b0ng \u0111i\u1ec1u tr\u1ecb do kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft ho\u1eb7c \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb t\u0103ng c\u01b0\u1eddng l\u00e0 23% \u1edf nh\u00f3m d\u00f9ng saxagliptin v\u00e0 32% \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>Li\u1ec1u insulin trung b\u00ecnh h\u1eb1ng ng\u00e0y l\u00e0 53 \u0111\u01a1n v\u1ecb \u1edf b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin 5 mg v\u00e0 55 \u0111\u01a1n v\u1ecb \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Thay \u0111\u1ed5i trung b\u00ecnh so v\u1edbi ban \u0111\u1ea7u c\u1ee7a li\u1ec1u insulin h\u1eb1ng ng\u00e0y l\u00e0 2 \u0111\u01a1n v\u1ecb \u1edf nh\u00f3m d\u00f9ng saxagliptin 5 mg v\u00e0 5 \u0111\u01a1n v\u1ecb \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1441\" height=\"1073\" class=\"wp-image-55501\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-846.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-846.png 1441w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-846-300x223.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-846-1209x900.png 1209w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-846-768x572.png 768w\" sizes=\"auto, (max-width: 1441px) 100vw, 1441px\" \/><\/p>\n<p>S\u1ef1 thay \u0111\u1ed5i \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i \u1edf tu\u1ea7n 24 so v\u1edbi ban \u0111\u1ea7u c\u0169ng \u0111\u01b0\u1ee3c ki\u1ec3m tra, nh\u01b0ng k\u1ebft qu\u1ea3 kh\u00f4ng \u0111\u1ea1t \u00fd ngh\u0129a th\u1ed1ng k\u00ea. T\u1ec9 l\u1ec7 b\u1ec7nh nh\u00e2n \u0111\u1ea1t HbA1C &lt; 7% l\u00e0 17% (52\/300) \u1edf nh\u00f3m d\u00f9ng ph\u1ed1i h\u1ee3p saxagliptin v\u00e0 insulin so v\u1edbi 7% (10\/149) \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c v\u00e0 insulin. Kh\u00f4ng ki\u1ec3m \u0111\u1ecbnh \u00fd ngh\u0129a th\u1ed1ng k\u00ea.<\/p>\n<p><em>S\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p saxagliptin v\u1edbi metformin v\u00e0 sulfonylur\u00ea<\/em><\/p>\n<p>T\u1ed5ng s\u1ed1 257 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 tham gia v\u00e0o m\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, m\u00f9 \u0111\u00f4i, ng\u1eabu nhi\u00ean trong 24 tu\u1ea7n \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a saxagliptin khi ph\u1ed1i h\u1ee3p v\u1edbi metformin v\u00e0 m\u1ed9t thu\u1ed1c sulfonylur\u00ea \u1edf c\u00e1c b\u1ec7nh nh\u00e2n ch\u01b0a ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft \u0111\u1ea7y \u0111\u1ee7 (7%\u2264 HbA1C \u226410%). B\u1ec7nh nh\u00e2n ph\u1ea3i \u0111ang s\u1eed d\u1ee5ng li\u1ec1u \u1ed5n \u0111\u1ecbnh metformin ph\u00f3ng th\u00edch k\u00e9o d\u00e0i ho\u1eb7c ph\u00f3ng th\u00edch t\u1ee9c th\u1eddi (\u1edf m\u1ee9c li\u1ec1u dung n\u1ea1p t\u1ed1i \u0111a, m\u1ee9c li\u1ec1u t\u1ed1i thi\u1ec3u \u0111\u1ec3 ch\u1ecdn b\u1ec7nh nh\u00e2n v\u00e0o nghi\u00ean c\u1ee9u l\u00e0 1500 mg) v\u00e0 m\u1ed9t thu\u1ed1c sulfonylur\u00ea (\u1edf m\u1ee9c li\u1ec1u dung n\u1ea1p t\u1ed1i \u0111a, m\u1ee9c li\u1ec1u t\u1ed1i thi\u1ec3u \u0111\u1ec3 ch\u1ecdn b\u1ec7nh nh\u00e2n v\u00e0o nghi\u00ean c\u1ee9u l\u00e0 \u226550% m\u1ee9c li\u1ec1u t\u1ed1i \u0111a khuy\u1ebfn c\u00e1o) trong \u00edt nh\u1ea5t 8 tu\u1ea7n tr\u01b0\u1edbc khi tham gia nghi\u00ean c\u1ee9u.<\/p>\n<p>Nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n ch\u1ecdn b\u1ec7nh \u0111\u01b0\u1ee3c tham gia v\u00e0o giai \u0111o\u1ea1n d\u1eabn nh\u1eadp trong 2 tu\u1ea7n \u0111\u1ec3 ki\u1ec3m tra c\u00e1c ch\u1ec9 ti\u00eau l\u1ef1a ch\u1ecdn\/lo\u1ea1i tr\u1eeb b\u1ec7nh nh\u00e2n. Sau 2 tu\u1ea7n d\u1eabn nh\u1eadp, b\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i v\u00e0o nh\u00f3m d\u00f9ng saxagliptin (5 mg\/ng\u00e0y) ho\u1eb7c nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c trong v\u00f2ng 24 tu\u1ea7n. Trong 24 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb m\u00f9 \u0111\u00f4i, b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c d\u00f9ng metformin v\u00e0 m\u1ed9t thu\u1ed1c sulfonylur\u00ea \u1edf m\u1ee9c li\u1ec1u \u1ed5n \u0111\u1ecbnh \u0111\u00e3 x\u00e1c \u0111\u1ecbnh \u1edf giai \u0111o\u1ea1n ch\u1ecdn b\u1ec7nh. C\u00f3 th\u1ec3 gi\u1ea3m li\u1ec1u sulfonylur\u00ea m\u1ed9t l\u1ea7n n\u1ebfu x\u1ea3y ra bi\u1ebfn c\u1ed1 h\u1ea1 glucose trong m\u00e1u n\u1eb7ng ho\u1eb7c c\u00e1c bi\u1ebfn c\u1ed1 h\u1ea1 glucose nh\u1eb9 l\u1eb7p l\u1ea1i. N\u1ebfu kh\u00f4ng x\u1ea3y ra h\u1ea1 glucose trong m\u00e1u, kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p \u0111i\u1ec1u ch\u1ec9nh (t\u0103ng ho\u1eb7c gi\u1ea3m) li\u1ec1u c\u1ee7a thu\u1ed1c trong qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>Saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi metformin v\u00e0 m\u1ed9t sulfonylur\u00ea gi\u00fap c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a ch\u1ec9 s\u1ed1 HbA1C v\u00e0 \u0111\u01b0\u1eddng huy\u1ebft sau \u0103n so v\u1edbi ph\u1ed1i h\u1ee3p gi\u1ea3 d\u01b0\u1ee3c v\u1edbi metformin v\u00e0 m\u1ed9t sulfonylur\u00ea (B\u1ea3ng 9). T\u1ec9 l\u1ec7 b\u1ec7nh nh\u00e2n ng\u01b0ng \u0111i\u1ec1u tr\u1ecb do kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft l\u00e0 6% \u1edf nh\u00f3m saxagliptin v\u00e0 5% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1441\" height=\"1002\" class=\"wp-image-55502\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-847.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-847.png 1441w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-847-300x209.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-847-1294x900.png 1294w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-847-768x534.png 768w\" sizes=\"auto, (max-width: 1441px) 100vw, 1441px\" \/><\/p>\n<p>Thay \u0111\u1ed5i \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00f3i \u1edf tu\u1ea7n 24 so v\u1edbi ban \u0111\u1ea7u c\u0169ng \u0111\u01b0\u1ee3c ki\u1ec3m tra, nh\u01b0ng kh\u00f4ng \u0111\u1ea1t \u00fd ngh\u0129a th\u1ed1ng k\u00ea. T\u1ec9 l\u1ec7 b\u1ec7nh nh\u00e2n \u0111\u1ea1t ch\u1ec9 s\u1ed1 HbA1C \u22647% l\u00e0 31% (39\/127) \u1edf nh\u00f3m d\u00f9ng saxagliptin ph\u1ed1i h\u1ee3p v\u1edbi metformin v\u00e0 sulfonylur\u00ea so v\u1edbi 9% (12\/127) \u1edf nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Kh\u00f4ng ki\u1ec3m \u0111\u1ecbnh \u00fd ngh\u0129a th\u1ed1ng k\u00ea.<\/p>\n<p><em>An to\u00e0n tim m\u1ea1ch<\/em><\/p>\n<p>Trong nghi\u00ean c\u1ee9u \u0111\u00e1nh gi\u00e1 d\u1ef1 h\u1eadu tim m\u1ea1ch c\u1ee7a saxagliptin tr\u00ean b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng &#8211; huy\u1ebft kh\u1ed1i trong nh\u1ed3i m\u00e1u c\u01a1 tim (SAVOR), \u1ea3nh h\u01b0\u1edfng c\u1ee7a saxagliptin \u0111\u1ebfn s\u1ef1 xu\u1ea5t hi\u1ec7n c\u00e1c bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh (CVD) \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 tr\u00ean 16.492 b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh ho\u1eb7c m\u1eafc b\u1ec7nh tim m\u1ea1ch ho\u1eb7c c\u00f3 nhi\u1ec1u y\u1ebfu t\u1ed1 nguy c\u01a1 c\u1ee7a b\u1ec7nh m\u1ea1ch m\u00e1u, bao g\u1ed3m c\u1ea3 b\u1ec7nh nh\u00e2n suy th\u1eadn trung b\u00ecnh ho\u1eb7c suy th\u1eadn n\u1eb7ng. B\u1ec7nh nh\u00e2n \u226540 tu\u1ed5i, \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 v\u00e0 HbA1c \u22656,5%, v\u00e0 x\u00e1c \u0111\u1ecbnh ho\u1eb7c c\u00f3 b\u1ec7nh tim m\u1ea1ch ho\u1eb7c c\u00f3 nhi\u1ec1u y\u1ebfu t\u1ed1 nguy c\u01a1 tim m\u1ea1ch \u0111\u01b0\u1ee3c tham gia.<\/p>\n<p>B\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c chia ng\u1eabu nghi\u00ean v\u00e0o nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c (n = 8212) ho\u1eb7c nh\u00f3m d\u00f9ng saxagliptin 1 l\u1ea7n\/ng\u00e0y (5 mg ho\u1eb7c 2,5 mg \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n suy th\u1eadn trung b\u00ecnh ho\u1eb7c suy th\u1eadn n\u1eb7ng) (n = 8280). S\u1ef1 ph\u00e2n chia ng\u1eabu nhi\u00ean b\u1ec7nh nh\u00e2n v\u00e0o nh\u00f3m d\u00f9ng saxagliptin v\u00e0 nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c d\u1ef1a tr\u00ean nguy c\u01a1 tim m\u1ea1ch g\u1ed3m 3533 b\u1ec7nh nh\u00e2n (21,4%) ch\u1ec9 c\u00f3 y\u1ebfu t\u1ed1 nguy c\u01a1 tim m\u1ea1ch v\u00e0 12.959 b\u1ec7nh nh\u00e2n (78,6%) \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh m\u1eafc b\u1ec7nh tim m\u1ea1ch, v\u00e0 d\u1ef1a v\u00e0o suy th\u1eadn g\u1ed3m 13.916 b\u1ec7nh nh\u00e2n (84,4%) c\u00f3 ch\u1ee9c n\u0103ng th\u1eadn b\u00ecnh th\u01b0\u1eddng ho\u1eb7c suy th\u1eadn nh\u1eb9, 2240 b\u1ec7nh nh\u00e2n (13,6%) suy th\u1eadn trung b\u00ecnh v\u00e0 336 b\u1ec7nh nh\u00e2n (2,0%) suy th\u1eadn n\u1eb7ng. B\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh tim m\u1ea1ch \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi ti\u1ec1n s\u1eed b\u1ec7nh thi\u1ebfu m\u00e1u c\u01a1 tim, b\u1ec7nh m\u1ea1ch m\u00e1u ngo\u1ea1i bi\u00ean, ho\u1eb7c \u0111\u1ed9t qu\u1ef5 do thi\u1ebfu m\u00e1u. B\u1ec7nh nh\u00e2n ch\u1ec9 c\u00f3 y\u1ebfu t\u1ed1 nguy c\u01a1 tim m\u1ea1ch v\u1edbi tu\u1ed5i l\u00e0 m\u1ed9t y\u1ebfu t\u1ed1 nguy c\u01a1 (nam \u226555 tu\u1ed5i v\u00e0 n\u1eef \u226560 tu\u1ed5i) k\u1ebft h\u1ee3p v\u1edbi \u00edt nh\u1ea5t m\u1ed9t trong c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 k\u00e8m theo nh\u01b0 r\u1ed1i lo\u1ea1n lipid m\u00e1u, t\u0103ng huy\u1ebft \u00e1p, ho\u1eb7c \u0111ang h\u00fat thu\u1ed1c l\u00e1.<\/p>\n<p>Nh\u00e2n kh\u1ea9u h\u1ecdc v\u00e0 c\u00e1c \u0111\u1eb7c \u0111i\u1ec3m c\u1ee7a b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00e2n b\u1eb1ng gi\u1eefa nh\u00f3m d\u00f9ng saxagliptin v\u00e0 nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. D\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u g\u1ed3m 67% nam gi\u1edbi v\u00e0 33% n\u1eef gi\u1edbi c\u00f3 tu\u1ed5i trung b\u00ecnh khi chia ng\u1eabu nhi\u00ean l\u00e0 65 tu\u1ed5i. Trong s\u1ed1 16.492 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn ng\u1eabu nhi\u00ean, c\u00f3 8561 (52%) b\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean v\u00e0 2330 (14%) b\u1ec7nh nh\u00e2n t\u1eeb 75 tu\u1ed5i tr\u1edf l\u00ean.<\/p>\n<p>T\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n c\u1ee7a nghi\u00ean c\u1ee9u c\u00f3 th\u1eddi gian \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 trung b\u00ecnh l\u00e0 12 n\u0103m (trung v\u1ecb = 10,3) v\u00e0 m\u1ee9c HbA1c trung b\u00ecnh l\u00e0 8,0% (trung v\u1ecb = 7,6%). C\u00f3 25% b\u1ec7nh nh\u00e2n trong t\u1ed5ng d\u00e2n s\u1ed1 c\u00f3 m\u1ee9c HbA1c ban \u0111\u1ea7u &lt;7%. B\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c theo d\u00f5i trong m\u1ed9t th\u1eddi gian trung b\u00ecnh 2 n\u0103m (trung v\u1ecb = 2,0).<\/p>\n<p>Thu\u1ed1c s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi \u0111\u1ec1u t\u01b0\u01a1ng t\u1ef1 nhau \u1edf 2 nh\u00f3m \u0111i\u1ec1u tr\u1ecb. Nh\u00ecn chung, s\u1eed d\u1ee5ng thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng th\u1ed1ng nh\u1ea5t v\u1edbi th\u1ef1c h\u00e0nh \u0111i\u1ec1u tr\u1ecb t\u1ea1i \u0111\u1ecba ph\u01b0\u01a1ng v\u00e0 ch\u01b0\u01a1ng tr\u00ecnh l\u00e2m s\u00e0ng c\u1ee7a saxagliptin (metformin 69%, insulin 41%, c\u00e1c thu\u1ed1c sulfonylur\u00ea 40%, v\u00e0 c\u00e1c thu\u1ed1c TZD 6%). S\u1eed d\u1ee5ng thu\u1ed1c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh tim m\u1ea1ch c\u0169ng th\u1ed1ng nh\u1ea5t v\u1edbi th\u1ef1c h\u00e0nh \u0111i\u1ec1u tr\u1ecb t\u1ea1i \u0111\u1ecba ph\u01b0\u01a1ng (c\u00e1c thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n ho\u1eb7c thu\u1ed1c ch\u1eb9n th\u1ee5 th\u1ec3 angiotensin 79%, c\u00e1c thu\u1ed1c statin 78%, aspirin 75%, c\u00e1c thu\u1ed1c ch\u1eb9n beta 62%, v\u00e0 c\u00e1c thu\u1ed1c ch\u1ed1ng k\u1ebft t\u1eadp ti\u1ec3u c\u1ea7u kh\u00f4ng aspirin 24%). Kho\u1ea3ng 6% b\u1ec7nh nh\u00e2n ch\u1ec9 s\u1eed d\u1ee5ng ch\u1ebf \u0111\u1ed9 \u0103n ki\u00eang v\u00e0 luy\u1ec7n t\u1eadp t\u1ea1i th\u1eddi \u0111i\u1ec3m ban \u0111\u1ea7u. S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd trong su\u1ed1t nghi\u00ean c\u1ee9u theo m\u1ee5c ti\u00eau c\u1ee7a h\u01b0\u1edbng d\u1eabn t\u1ea1i \u0111\u1ecba ph\u01b0\u01a1ng v\u1ec1 ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft v\u00e0 v\u1ec1 gi\u1ea3m nguy c\u01a1 tim m\u1ea1ch \u0111\u1ec3 gi\u1ea3m thi\u1ec3u s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa 2 nh\u00f3m \u0111i\u1ec1u tr\u1ecb, \u0111\u1eb7c bi\u1ec7t l\u00e0 v\u1ec1 ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft.<\/p>\n<p>Ti\u00eau ch\u00ed ch\u00ednh v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 l\u00e0 1 ti\u00eau ch\u00ed t\u1ed5 h\u1ee3p g\u1ed3m th\u1eddi gian t\u00e1i ph\u00e1t l\u1ea7n \u0111\u1ea7u ti\u00ean c\u1ee7a b\u1ea5t k\u1ef3 bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh (MACE) sau \u0111\u00e2y: t\u1eed vong do tim m\u1ea1ch, nh\u1ed3i m\u00e1u c\u01a1 tim kh\u00f4ng t\u1eed vong, ho\u1eb7c \u0111\u1ed9t qu\u1ef5 kh\u00f4ng t\u1eed vong.<\/p>\n<p>M\u1ee5c ti\u00eau an to\u00e0n ch\u00ednh c\u1ee7a nghi\u00ean c\u1ee9u n\u00e0y l\u00e0 \u0111\u1ec3 thi\u1ebft l\u1eadp gi\u1edbi h\u1ea1n tr\u00ean \u1edf 2 ph\u00eda c\u1ee7a kho\u1ea3ng tin c\u1eady 95% c\u1ee7a t\u1ef7 s\u1ed1 nguy c\u01a1 \u01b0\u1edbc t\u00ednh khi so s\u00e1nh xu\u1ea5t \u0111\u1ed9 c\u1ee7a ti\u00eau ch\u00ed t\u1ed5 h\u1ee3p c\u1ee7a c\u00e1c bi\u1ebfn c\u1ed1 t\u1eed vong do tim m\u1ea1ch, nh\u1ed3i m\u00e1u c\u01a1 tim kh\u00f4ng t\u1eed vong, ho\u1eb7c \u0111\u1ed9t qu\u1ef5 kh\u00f4ng t\u1eed vong \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf nh\u00f3m d\u00f9ng saxagliptin v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c l\u00e0 &lt;1,3.<\/p>\n<p>M\u1ee5c ti\u00eau hi\u1ec7u qu\u1ea3 ch\u00ednh, l\u00e0 \u0111\u00e1nh gi\u00e1 v\u01b0\u1ee3t tr\u1ed9i, \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb saxagliptin so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c khi b\u1ed5 sung v\u00e0o li\u1ec7u ph\u00e1p n\u1ec1n hi\u1ec7n t\u1ea1i c\u00f3 l\u00e0m gi\u1ea3m \u0111\u00e1ng k\u1ec3 ti\u00eau ch\u00ed ch\u00ednh v\u1ec1 bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh hay kh\u00f4ng.<\/p>\n<p>Ti\u00eau ch\u00ed hi\u1ec7u qu\u1ea3 ph\u1ee5 \u0111\u1ea7u ti\u00ean l\u00e0 m\u1ed9t ti\u00eau ch\u00ed t\u1ed5 h\u1ee3p bao g\u1ed3m th\u1eddi gian t\u00e1i ph\u00e1t l\u1ea7n \u0111\u1ea7u ti\u00ean c\u1ee7a bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh (MACE) k\u1ebft h\u1ee3p v\u1edbi nh\u1eadp vi\u1ec7n do suy tim, nh\u1eadp vi\u1ec7n do \u0111au th\u1eaft ng\u1ef1c kh\u00f4ng \u1ed5n \u0111\u1ecbnh, nh\u1eadp vi\u1ec7n do t\u00e1i th\u00f4ng m\u1ea1ch v\u00e0nh (bi\u1ebfn c\u1ed1 tim m\u1ea1ch ch\u00ednh k\u1ebft h\u1ee3p). Ti\u00eau ch\u00ed hi\u1ec7u qu\u1ea3 ph\u1ee5 th\u1ee9 hai l\u00e0 \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb saxagliptin so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c khi b\u1ed5 sung v\u00e0o li\u1ec7u ph\u00e1p n\u1ec1n hi\u1ec7n t\u1ea1i \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 c\u00f3 l\u00e0m gi\u1ea3m t\u1eed vong do m\u1ecdi nguy\u00ean nh\u00e2n hay kh\u00f4ng.<\/p>\n<p>An to\u00e0n tim m\u1ea1ch c\u1ee7a saxagliptin \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong nghi\u00ean c\u1ee9u SAVOR, x\u00e1c \u0111\u1ecbnh saxagliptin kh\u00f4ng l\u00e0m t\u0103ng nguy c\u01a1 tim m\u1ea1ch (t\u1eed vong do tim m\u1ea1ch, nh\u1ed3i m\u00e1u c\u01a1 tim kh\u00f4ng t\u1eed vong, ho\u1eb7c \u0111\u1ed9t qu\u1ef5 kh\u00f4ng t\u1eed vong) \u1edf b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c khi ph\u1ed1i h\u1ee3p v\u1edbi li\u1ec7u ph\u00e1p n\u1ec1n hi\u1ec7n t\u1ea1i (t\u1ef7 s\u1ed1 nguy c\u01a1 [HR]: 1,00; kho\u1ea3ng tin c\u1eady [CI] 95%: 0,89, 1,12; P&lt;0,001 cho ph\u00e2n t\u00edch kh\u00f4ng k\u00e9m h\u01a1n).<\/p>\n<p>Ti\u00eau ch\u00ed hi\u1ec7u qu\u1ea3 ch\u00ednh kh\u00f4ng ch\u1ee9ng minh \u0111\u01b0\u1ee3c s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129 th\u1ed1ng k\u00ea cho bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd ch\u00ednh v\u1ec1 m\u1ea1ch v\u00e0nh c\u1ee7a saxagliptin tr\u00ean b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2 so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c khi ph\u1ed1i h\u1ee3p v\u1edbi li\u1ec7u ph\u00e1p n\u1ec1n hi\u1ec7n t\u1ea1i.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1441\" height=\"846\" class=\"wp-image-55503\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-848.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-848.png 1441w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-848-300x176.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-848-768x451.png 768w\" sizes=\"auto, (max-width: 1441px) 100vw, 1441px\" \/><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"731\" height=\"527\" class=\"wp-image-55504\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-849.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-849.png 731w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-849-300x216.png 300w\" sizes=\"auto, (max-width: 731px) 100vw, 731px\" \/><\/p>\n<p>Bi\u1ebfn c\u1ed1 t\u00edch l\u0169y nh\u1ea5t qu\u00e1n theo th\u1eddi gian, v\u00e0 t\u1ef7 l\u1ec7 bi\u1ebfn c\u1ed1 c\u1ee7a KOMBOGLYZE XR v\u00e0 gi\u1ea3 d\u01b0\u1ee3c kh\u00f4ng kh\u00e1c bi\u1ec7t \u0111\u00e1ng k\u1ec3 theo th\u1eddi gian.<\/p>\n<p>M\u1ed9t th\u00e0nh ph\u1ea7n c\u1ee7a ti\u00eau ch\u00ed t\u1ed5 h\u1ee3p ph\u1ee5, nh\u1eadp vi\u1ec7n do suy tim, x\u1ea3y ra v\u1edbi t\u1ef7 l\u1ec7 cao h\u01a1n \u1edf nh\u00f3m saxagliptin (3,5%) so v\u1edbi nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c (2,8%), v\u1edbi \u00fd ngh\u0129a th\u1ed1ng k\u00ea d\u1ea1ng d\u1eef li\u1ec7u \u0111\u1ecbnh danh (v\u00ed d\u1ee5 nh\u01b0 kh\u00f4ng c\u00f3 s\u1ef1 \u0111i\u1ec1u ch\u1ec9nh trong nghi\u00ean c\u1ee9u c\u00f3 nhi\u1ec1u ti\u00eau ch\u00ed) nghi\u00eang v\u1ec1 ph\u00eda gi\u1ea3 d\u01b0\u1ee3c [HR = 1,27; [95% CI: 1,07, 1,51]; P = 0,007). C\u00e1c y\u1ebfu t\u1ed1 l\u00e2m s\u00e0ng d\u1ef1 \u0111o\u00e1n t\u0103ng nguy c\u01a1 t\u01b0\u01a1ng \u0111\u1ed1i v\u1edbi \u0111i\u1ec1u tr\u1ecb saxagliptin kh\u00f4ng x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c r\u00f5 r\u00e0ng. Nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 nh\u1eadp vi\u1ec7n do suy tim cao h\u01a1n, kh\u00f4ng ph\u00e2n bi\u1ec7t nh\u00f3m \u0111i\u1ec1u tr\u1ecb, l\u00e0 nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng nh\u1eefng y\u1ebfu t\u1ed1 nguy c\u01a1 suy tim \u0111\u00e3 bi\u1ebft nh\u01b0 ti\u1ec1n s\u1eed suy tim ho\u1eb7c suy ch\u1ee9c n\u0103ng th\u1eadn l\u00fac ban \u0111\u1ea7u. Tuy nhi\u00ean, nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng saxagliptin \u0111\u00e3 c\u00f3 ti\u1ec1n s\u1eed suy tim ho\u1eb7c suy ch\u1ee9c n\u0103ng th\u1eadn l\u00fac ban \u0111\u1ea7u kh\u00f4ng t\u0103ng nguy c\u01a1 t\u01b0\u01a1ng \u0111\u1ed1i so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c tr\u00ean ti\u00eau ch\u00ed t\u1ed5 h\u1ee3p ch\u00ednh ho\u1eb7c ph\u1ee5 ho\u1eb7c tr\u00ean t\u1ec9 l\u1ec7 t\u1eed vong do m\u1ecdi nguy\u00ean nh\u00e2n. Kh\u00f4ng t\u0103ng nguy c\u01a1 c\u1ee7a ti\u00eau ch\u00ed ch\u00ednh \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf saxagliptin v\u00e0 gi\u1ea3 d\u01b0\u1ee3c trong b\u1ea5t k\u1ef3 ph\u00e2n nh\u00f3m sau: b\u1ec7nh tim m\u1ea1ch, c\u00f3 nhi\u1ec1u y\u1ebfu t\u1ed1 nguy c\u01a1 c\u1ee7a b\u1ec7nh tim m\u1ea1ch, suy th\u1eadn nh\u1eb9, trung b\u00ecnh ho\u1eb7c n\u1eb7ng, tu\u1ed5i, gi\u1edbi t\u00ednh, ch\u1ee7ng t\u1ed9c, khu v\u1ef1c, th\u1eddi gian b\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2, ti\u1ec1n s\u1eed suy tim, HbA1c l\u00fac ban \u0111\u1ea7u, t\u1ef7 s\u1ed1 albumin\/creatinin, thu\u1ed1c \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng l\u00fac ban \u0111\u1ea7u, ho\u1eb7c s\u1eed d\u1ee5ng statin, aspirin, thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n, thu\u1ed1c ch\u1eb9n th\u1ee5 th\u1ec3 angiotensin, thu\u1ed1c ch\u1eb9n beta, ho\u1eb7c c\u00e1c thu\u1ed1c ch\u1ed1ng k\u1ebft t\u1eadp ti\u1ec3u c\u1ea7u l\u00fac ban \u0111\u1ea7u. M\u1eb7c d\u00f9 c\u00f3 qu\u1ea3n l\u00fd ch\u1ee7 \u0111\u1ed9ng vi\u1ec7c s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi thu\u1ed1c tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng \u1edf c\u1ea3 hai nh\u00f3m nghi\u00ean c\u1ee9u, m\u1ee9c HbA1c trung b\u00ecnh c\u1ee7a nh\u00f3m d\u00f9ng saxagliptin th\u1ea5p h\u01a1n so v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c \u1edf N\u0103m 1 (7,6% so v\u1edbi 7,9%, kh\u00e1c bi\u1ec7t -0,35% [95% CI: -0,38, -0,31]) v\u00e0 \u1edf N\u0103m 2 (7,6% so v\u1edbi 7,9%, kh\u00e1c bi\u1ec7t -0,30% [95% CI: -0,34, -0,26]). T\u1ef7 l\u1ec7 ph\u1ea7n tr\u0103m b\u1ec7nh nh\u00e2n c\u00f3 HbA1c &lt;7% \u1edf nh\u00f3m d\u00f9ng saxagliptin so v\u1edbi nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c l\u00e0 38% so v\u1edbi 27% \u1edf N\u0103m 1 v\u00e0 38% so v\u1edbi 29% \u1edf N\u0103m 2.<\/p>\n<p>So v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, saxagliptin c\u00f3 nhu c\u1ea7u \u00edt s\u1eed d\u1ee5ng h\u01a1n v\u1edbi kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb m\u1edbi, ho\u1eb7c t\u0103ng li\u1ec1u trong \u0111i\u1ec1u tr\u1ecb hi\u1ec7n t\u1ea1i, v\u1edbi c\u00e1c thu\u1ed1c tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng \u0111\u01b0\u1eddng u\u1ed1ng ho\u1eb7c insulin. S\u1ef1 c\u1ea3i thi\u1ec7n HbA1c v\u00e0 t\u1ef7 l\u1ec7 ph\u1ea7n tr\u0103m b\u1ec7nh nh\u00e2n \u0111\u1ea1t HbA1c m\u1ee5c ti\u00eau trong s\u1ed1 c\u00e1c b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb v\u1edbi saxagliptin \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn m\u1eb7c d\u00f9 \u0111i\u1ec1u ch\u1ec9nh t\u0103ng li\u1ec1u c\u00e1c thu\u1ed1c tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng, ho\u1eb7c kh\u1edfi \u0111\u1ea7u thu\u1ed1c tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng \u0111i\u1ec1u tr\u1ecb m\u1edbi ho\u1eb7c insulin c\u00f3 t\u1ef7 l\u1ec7 th\u1ea5p h\u01a1n so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"54-du-lieu-tien-lam-sang\"><\/span>5.4. D\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Ch\u01b0a c\u00f3 th\u00f4ng tin. \u0110ang c\u1eadp nh\u1eadt.<\/p>\n<p><strong><em>*L\u01b0u \u00fd:<\/em><\/strong><\/p>\n<p><strong><em>C\u00e1c th\u00f4ng tin v\u1ec1 thu\u1ed1c tr\u00ean Pharmog.com ch\u1ec9 mang t\u00ednh ch\u1ea5t tham kh\u1ea3o &#8211; Khi d\u00f9ng thu\u1ed1c c\u1ea7n tuy\u1ec7t \u0111\u1ed1i tu\u00e2n theo theo h\u01b0\u1edbng d\u1eabn c\u1ee7a B\u00e1c s\u0129 <\/em><\/strong><\/p>\n<p><strong><em>Ch\u00fang t\u00f4i kh\u00f4ng ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 b\u1ea5t c\u1ee9 h\u1eadu qu\u1ea3 n\u00e0o x\u1ea3y ra do t\u1ef1 \u00fd d\u00f9ng thu\u1ed1c d\u1ef1a theo c\u00e1c th\u00f4ng tin tr\u00ean Pharmog.com<\/em><\/strong><\/p>\n<p><strong><em><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6-phan-thong-tin-kem-theo-cua-thuoc\"><\/span>6. Ph\u1ea7n th\u00f4ng tin k\u00e8m theo c\u1ee7a thu\u1ed1c:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"61-danh-muc-ta-duoc\"><\/span>6.1. Danh m\u1ee5c t\u00e1 d\u01b0\u1ee3c:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>M\u1ed7i vi\u00ean n\u00e9n bao phim KOMBOGLYZE XR ch\u1ee9a c\u00e1c t\u00e1 d\u01b0\u1ee3c: Natri carboxymethylcellulose, hypromellose 2208, v\u00e0 magnesi stearat. Vi\u00ean KOMBOGLYZE XR h\u00e0m l\u01b0\u1ee3ng 5mg\/500mg c\u0169ng c\u00f3 ch\u1ee9a cellulose vi tinh th\u1ec3 v\u00e0 hypromellose 2910. Th\u00eam v\u00e0o \u0111\u00f3, m\u00e0ng bao phim c\u00f3 ch\u1ee9a c\u00e1c t\u00e1 d\u01b0\u1ee3c: polyvinyl alcohol, polyethylen glycol 3350, titan dioxyd, talc, v\u00e0 c\u00e1c oxyd s\u1eaft.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"62-tuong-ky\"><\/span>6.2. T\u01b0\u01a1ng k\u1ef5 :<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Kh\u00f4ng \u00e1p d\u1ee5ng.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"63-bao-quan\"><\/span>6.3. B\u1ea3o qu\u1ea3n:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>N\u01a1i kh\u00f4, tr\u00e1nh \u00e1nh s\u00e1ng, nhi\u1ec7t \u0111\u1ed9 d\u01b0\u1edbi 30\u00b0C.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"64-thong-tin-khac\"><\/span>6.4. Th\u00f4ng tin kh\u00e1c :<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Vi\u00ean KOMBOGLYZE XR (saxagliptin v\u00e0 metformin HCl ph\u00f3ng th\u00edch k\u00e9o d\u00e0i) c\u00f3 ch\u1ee9a hai ho\u1ea1t ch\u1ea5t ch\u1ed1ng t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft, d\u1ea1ng u\u1ed1ng, d\u00f9ng \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng t\u00fdp 2: saxagliptin v\u00e0 metformin hydroclorid.<\/p>\n<p><em>Saxagliptin<\/em><\/p>\n<p>Saxagliptin l\u00e0 t\u00e1c nh\u00e2n \u1ee9c ch\u1ebf ch\u1ee7 \u0111\u1ed9ng enzym dipeptidyl-peptidase-4 (DPP4) d\u00f9ng qua \u0111\u01b0\u1eddng u\u1ed1ng.<\/p>\n<p>Saxagliptin monohydrat c\u00f3 c\u00f4ng th\u1ee9c h\u00f3a h\u1ecdc l\u00e0 (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate ho\u1eb7c (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0] hexane-3-carbonitrile hydrate. C\u00f4ng th\u1ee9c ph\u00e2n t\u1eed l\u00e0 C18H25N3O2\u00b7H2O v\u00e0 tr\u1ecdng l\u01b0\u1ee3ng ph\u00e2n t\u1eed l\u00e0 333,43.<\/p>\n<p>Saxagliptin monohydrat \u1edf d\u1ea1ng b\u1ed9t k\u1ebft tinh, c\u00f3 m\u00e0u t\u1eeb tr\u1eafng \u0111\u1ebfn v\u00e0ng nh\u1ea1t ho\u1eb7c n\u00e2u nh\u1ea1t, kh\u00f4ng h\u00fat \u1ea9m. Ch\u1ea5t n\u00e0y k\u00e9m tan trong n\u01b0\u1edbc \u1edf nhi\u1ec7t \u0111\u1ed9 24oC\u00b13oC, tan \u00edt trong ethyl acetat v\u00e0 tan trong methanol, ethanol, isopropyl alcohol, acetonitril, aceton v\u00e0 polyethylen glycol 400 (PEG 400).<\/p>\n<p><em>Metformin hydroclorid<\/em><\/p>\n<p>Metformin hydroclorid (N,N-dimethylimidodicarbonimidic diamide hydroclorid) \u1edf d\u1ea1ng b\u1ed9t k\u1ebft tinh t\u1eeb m\u00e0u tr\u1eafng \u0111\u1ebfn tr\u1eafng ng\u00e0, c\u00f3 c\u00f4ng th\u1ee9c ph\u00e2n t\u1eed l\u00e0 C4H11N5\u00b7HCl v\u00e0 tr\u1ecdng l\u01b0\u1ee3ng ph\u00e2n t\u1eed l\u00e0 165,63. Metformin hydroclorid tan t\u1ef1 do trong n\u01b0\u1edbc, tan \u00edt trong alcol v\u00e0 k\u00e9m tan trong aceton, ether, v\u00e0 cloroform. Gi\u00e1 tr\u1ecb pKa c\u1ee7a metformin l\u00e0 12,4. \u0110\u1ed9 pH c\u1ee7a dung d\u1ecbch 1% metformin hydroclorid trong n\u01b0\u1edbc l\u00e0 6,68.<\/p>\n<p><em>KOMBOGLYZE XR<\/em><\/p>\n<p>KOMBOGLYZE XR \u0111\u01b0\u1ee3c b\u00e0o ch\u1ebf \u1edf d\u1ea1ng vi\u00ean u\u1ed1ng, ch\u1ee9a 5,58 mg saxagliptin hydroclorid (d\u1ea1ng khan) t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi 5 mg saxagliptin v\u00e0 500 mg metformin hydroclorid (KOMBOGLYZE XR 5mg\/500mg), ho\u1eb7c 5,58 mg saxagliptin hydroclorid (d\u1ea1ng khan) t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi 5 mg saxagliptin v\u00e0 1000 mg metformin hydroclorid (KOMBOGLYZE XR 5mg\/1000mg) ho\u1eb7c 2,79 mg saxagliptin hydroclorid (d\u1ea1ng khan) t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi 2,5 mg saxagliptin v\u00e0 1000 mg metformin hydroclorid (KOMBOGLYZE XR 2,5mg\/1000mg).<\/p>\n<p>C\u00e1c th\u00e0nh ph\u1ea7n tr\u01a1 v\u1ec1 m\u1eb7t sinh h\u1ecdc c\u1ee7a vi\u00ean thu\u1ed1c \u0111\u00f4i khi gi\u1eef nguy\u00ean tr\u1ea1ng trong qu\u00e1 tr\u00ecnh lu\u00e2n chuy\u1ec3n \u1edf d\u1ea1 d\u00e0y-ru\u1ed9t v\u00e0 s\u1ebd \u0111\u01b0\u1ee3c \u0111\u00e0o th\u1ea3i d\u01b0\u1edbi d\u1ea1ng m\u1ed9t kh\u1ed1i m\u1ec1m, ng\u1eadm n\u01b0\u1edbc trong ph\u00e2n.<\/p>\n<p><em>D\u1ea1ng b\u00e0o ch\u1ebf<\/em><\/p>\n<p>Vi\u00ean 5\/500: Vi\u00ean n\u00e9n bao phim c\u00f3 m\u00e0u n\u00e2u hay n\u00e2u nh\u1ea1t, hai m\u1eb7t l\u1ed3i, h\u00ecnh d\u1ea1ng vi\u00ean nang, c\u00f3 in s\u1ed1 m\u00e0u xanh \u201c5\/500\u201d tr\u00ean m\u1ed9t m\u1eb7t v\u00e0 \u201c4221\u201d tr\u00ean m\u1eb7t kia.<\/p>\n<p>Vi\u00ean 5\/1000: Vi\u00ean n\u00e9n bao phim c\u00f3 m\u00e0u h\u1ed3ng, hai m\u1eb7t l\u1ed3i, h\u00ecnh d\u1ea1ng vi\u00ean nang, c\u00f3 in s\u1ed1 m\u00e0u xanh \u201c5\/1000\u201d tr\u00ean m\u1ed9t m\u1eb7t v\u00e0 \u201c4223\u201d tr\u00ean m\u1eb7t kia.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"65-tai-lieu-tham-khao\"><\/span>6.5 T\u00e0i li\u1ec7u tham kh\u1ea3o:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>HDSD Thu\u1ed1c Komboglyze XR do AstraZeneca Pharmaceuticals LP s\u1ea3n xu\u1ea5t (2015).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"7-nguoi-dang-tai-tac-gia\"><\/span>7. Ng\u01b0\u1eddi \u0111\u0103ng t\u1ea3i \/T\u00e1c gi\u1ea3:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>B\u00e0i vi\u1ebft \u0111\u01b0\u1ee3c s\u01b0u t\u1ea7m ho\u1eb7c vi\u1ebft b\u1edfi: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-tac-gia-bac-sy-do-my-linh\/\">B\u00e1c s\u0129 nhi khoa &#8211; \u0110\u1ed7 M\u1ef9 Linh.<\/a><\/p>\n<p>Ki\u1ec3m duy\u1ec7t , hi\u1ec7u \u0111\u00ednh v\u00e0 \u0111\u0103ng t\u1ea3i: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-ve-pharmog-team\/\">PHARMOG TEAM<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Th\u00f4ng tin t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c Komboglyze XR D\u01b0\u1edbi \u0111\u00e2y l\u00e0 n\u1ed9i dung t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a Thu\u1ed1c Komboglyze XR (Th\u00f4ng tin bao g\u1ed3m li\u1ec1u d\u00f9ng, c\u00e1ch d\u00f9ng, ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, th\u1eadn tr\u1ecdng, d\u01b0\u1ee3c l\u00fd&#8230;) 1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c: Ho\u1ea1t ch\u1ea5t : Metformin + Saxagliptin [&hellip;]<\/p>\n","protected":false},"author":8612,"featured_media":55495,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[370],"tags":[1307,2150,1327],"class_list":["post-8140","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biet-duoc-goc","tag-metformin","tag-metformin-saxagliptin","tag-saxagliptin"],"_links":{"self":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/8140","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/users\/8612"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/comments?post=8140"}],"version-history":[{"count":4,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/8140\/revisions"}],"predecessor-version":[{"id":55525,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/8140\/revisions\/55525"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media\/55495"}],"wp:attachment":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media?parent=8140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/categories?post=8140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/tags?post=8140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}