{"id":13184,"date":"2011-11-09T15:59:32","date_gmt":"2011-11-09T20:59:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=13184"},"modified":"2011-11-09T15:59:32","modified_gmt":"2011-11-09T20:59:32","slug":"18-months-after-accord-fda-says-fenofibrate-may-not-lower-risk-for-mi-or-stroke","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/11\/09\/18-months-after-accord-fda-says-fenofibrate-may-not-lower-risk-for-mi-or-stroke\/","title":{"rendered":"18 Months After ACCORD, FDA Says Fenofibrate May Not Lower Risk for MI or Stroke"},"content":{"rendered":"<p>Eighteen months after<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1001282\"> the ACCORD (Action to Control Cardiovascular Risk in Diabetes )\u00a0trial<\/a> found no benefit for the addition of fenofibrate to simvastatin in patients with type 2 diabetes, the FDA has issued <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm278837.htm\">a safety communication<\/a>. The agency changed the label for Trilipix (fenofibric acid, Abbott) and is notifying healthcare professionals that the drug &#8220;may not lower a patient&#8217;s risk of having a heart attack or stroke.&#8221; The information about ACCORD has been added to the\u00a0<em>Important Limitations of Use<\/em> and <em>Warnings and Precautions<\/em> sections of the label, as well as the patient Medication Guide.<\/p>\n<p>The FDA has also required Abbott to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that fenofibrate in combination with a statin versus statin alone significantly reduces cardiovascular events in high-risk men and women who are at their LDL cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Eighteen months after the ACCORD (Action to Control Cardiovascular Risk in Diabetes )\u00a0trial found no benefit for the addition of fenofibrate to simvastatin in patients with type 2 diabetes, the FDA has issued a safety communication. The agency changed the label for Trilipix (fenofibric acid, Abbott) and is notifying healthcare professionals that the drug &#8220;may [&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":[],"class_list":["post-13184","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13184","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=13184"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13184\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=13184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=13184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=13184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}