{"id":35799,"date":"2013-03-29T16:09:26","date_gmt":"2013-03-29T20:09:26","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=35799"},"modified":"2013-03-29T16:56:48","modified_gmt":"2013-03-29T20:56:48","slug":"fda-approves-first-sglt2-inhibitor-for-diabetes","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/03\/29\/fda-approves-first-sglt2-inhibitor-for-diabetes\/","title":{"rendered":"FDA Approves First SGLT2 Inhibitor for Diabetes"},"content":{"rendered":"<p>The FDA\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm345848.htm\">said<\/a>\u00a0today that it had approved canaglifozin (Invokana, Johnson &amp; Johnson), the first of a new class of diabetes drugs known as\u00a0sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated,\u00a0in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes, including\u00a0metformin, sulfonylurea, pioglitazone, and insulin.<\/p>\n<p>The FDA said it was requiring J&amp;J to perform five postmarketing studies with\u00a0canaglifozin, including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; and a bone safety study.<\/p>\n<p>Vaginal yeast infections and urinary tract infections are the most common side effects associated with\u00a0canaglifozin. The FDA said canaglifozin\u00a0should\u00a0not be used to treat people with type 1 diabetes or in people with diabetic ketoacidosis or severe renal disease.<\/p>\n<p>In clinical trials in over 10,000 patients with type 2 diabetes, canaglifozin was shown to improve\u00a0hemoglobin A1c levels and fasting plasma glucose levels.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA\u00a0said\u00a0today that it had approved canaglifozin (Invokana, Johnson &amp; Johnson), the first of a new class of diabetes drugs known as\u00a0sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated,\u00a0in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy and in combination with [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[1748,200,1749,469],"class_list":["post-35799","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-canaglifozin","tag-diabetes","tag-sglt2","tag-type-2-diabetes"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35799","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=35799"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35799\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=35799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=35799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=35799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}