{"id":43232,"date":"2014-05-13T20:18:44","date_gmt":"2014-05-14T00:18:44","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=43232"},"modified":"2014-05-13T20:18:44","modified_gmt":"2014-05-14T00:18:44","slug":"a-second-darapladib-phase-3-trial-misses-its-endpoint","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/05\/13\/a-second-darapladib-phase-3-trial-misses-its-endpoint\/","title":{"rendered":"A Second Darapladib Phase 3 Trial Misses Its Endpoint"},"content":{"rendered":"<p>GSK\u00a0<a href=\"http:\/\/www.gsk.com\/media\/press-releases\/2014\/gsk-announces-phase-iii-study-with-darapladib-did-not-meet-prima.html\">said<\/a>\u00a0today that a large phase 3 trial of a once highly promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would &#8220;further analyse the data and better understand the findings&#8221; but that, for now at least, it would not seek regulatory approval for the drug.<\/p>\n<p>The\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/record\/NCT01000727?term=SOLID-TIMI+52&amp;rank=1\">SOLID-TIMI 52<\/a>\u00a0(Stabilisation Of pLaques usIng Darapladib &#8211; Thrombolysis In Myocardial Infarction 52) trial randomized more than 13,000 patients within 30 days of an acute coronary syndrome to receive either placebo or darapladib, an anti-inflammatory drug designed to stabilize atherosclerotic plaques. GSK reported today that the drug did not significantly reduce major coronary events.\u00a0\u00a0The full results of\u00a0the trial will be presented at a future scientific meeting.<\/p>\n<p>Last November GSK\u00a0<a href=\"http:\/\/www.gsk.com\/media\/press-releases\/2013\/gsk-announces-top-line-results-from-pivotal-phase-iii-study-of-d.html\">announced<\/a>\u00a0 that the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00799903?term=STABILITY+trial&amp;rank=3\">STABILITY trial<\/a>\u00a0(STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY)\u00a0had failed to meet its primary endpoint. In that trial darapladib was compared with placebo in more than 15,000 patients with chronic coronary heart disease. The main results of the trial were then\u00a0presented\u00a0in March at the American College of Cardiology meeting and\u00a0<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1315878\">published simultaneously in the\u00a0<em>New England Journal of Medicine<\/em><\/a>.<\/p>\n<p>GSK said that the two trials had uncovered &#8220;no major safety concerns&#8221; with the drug. But an ongoing issue has been that darapladib causes unpleasant odors in feces and urine in some people taking the drug.\u00a0Darapladib was originally developed by Human Genome Sciences. It was a key reason why GSK acquired that company.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>GSK\u00a0said\u00a0today that a large phase 3 trial of a once highly promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would &#8220;further analyse the data and better understand the findings&#8221; but that, for now at least, [&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":[239,2055,2253],"class_list":["post-43232","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-acs","tag-darapladib","tag-gsk"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43232","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=43232"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43232\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=43232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=43232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=43232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}