{"id":8356,"date":"2011-05-19T18:07:18","date_gmt":"2011-05-19T22:07:18","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=8356"},"modified":"2011-07-19T17:44:24","modified_gmt":"2011-07-19T21:44:24","slug":"fda-panel-delivers-mixed-verdict-on-trilipix-fenofibrate","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/05\/19\/fda-panel-delivers-mixed-verdict-on-trilipix-fenofibrate\/","title":{"rendered":"FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)"},"content":{"rendered":"<p>The FDA&#8217;s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high-risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol levels on statin therapy.<\/p>\n<p>On the other hand, 9 panelists voted to keep (3 votes) or incorporate the findings from ACCORD (6 votes) in the current label. Four panelists voted to withdraw the indication.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high-risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol levels [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[723,744,849],"class_list":["post-8356","post","type-post","status-publish","format-standard","hentry","category-prevention","tag-accord","tag-fenofibrate","tag-trlipix"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8356","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=8356"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8356\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=8356"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=8356"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=8356"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}