{"id":37264,"date":"2013-06-28T15:11:33","date_gmt":"2013-06-28T19:11:33","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=37264"},"modified":"2013-06-28T15:11:33","modified_gmt":"2013-06-28T19:11:33","slug":"more-bad-news-for-hdl-therapies-assure-trial-misses-primary-endpoint","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/06\/28\/more-bad-news-for-hdl-therapies-assure-trial-misses-primary-endpoint\/","title":{"rendered":"More Bad News for HDL Therapies: ASSURE Trial Misses Primary Endpoint"},"content":{"rendered":"

The string of bad news for HDL-related therapies continues. Resverlogix yesterday\u00a0announced<\/a>\u00a0that the ASSURE clinical trial had failed to meet its primary endpoint. RVX-208, the drug being studied in the trial, is a novel small molecule that increases production of Apolipoprotein A-I (ApoA-1), which raises HDL levels and is thought to enhance reverse cholesterol transport.<\/p>\n

ASSURE\u00a0<\/a>was a phase 2b multicenter, double-blind, randomized, parallel group, placebo-controlled trial studying RVX-208 in 324 patients with coronary artery disease and low HDL levels. The company said the trial “did not meet its primary endpoint of a -0.6% change in percent atheroma volume as determined by intravascular ultrasound (IVUS). The RVX-208 treated group had -0.4% plaque regression (p=0.08).” The company reported that the trial did meet “the secondary endpoints of regression of total (coronary) atheroma volume (TAV) and increases in Apolipoprotein A-I (ApoA-I) and HDL cholesterol.” The company said that results in the placebo arm of the study were stronger than expected.<\/p>\n

Full results of the trial are expected to be presented later this year. Earlier this month the company\u00a0said<\/a>\u00a0the results may be presented at the European Society of Cardiology meeting in Amsterdam at the end of the summer.<\/p>\n

ASSURE was run by the Cleveland Clinic. Steve Nissen is the chairman of the trial and Stephen Nicholls is the principal investigator.<\/p>\n

In recent years the once-highly promising area of HDL-raising therapies has experienced a series of disappointments. Large trials with niacin (AIM-HIGH<\/a>\u00a0and\u00a0HPS2-THRIVE<\/a>) and\u00a0CETP inhibitors\u00a0(Pfizer’s anacetrapib and Roche’s\u00a0dalcetrapib<\/a>) have failed spectacularly. Some critics maintain that although the drugs in these trials raised HDL levels, they did not enhance the functional aspect of HDL. RVX-208 was intended to do just that. One remaining question about ASSURE is whether a 26-week study with an IVUS endpoint was actually capable of measuring the potential clinical benefits of the drug. IVUS has never been validated as a surrogate endpoint.<\/p>\n

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The string of bad news for HDL-related therapies continues. Resverlogix yesterday\u00a0announced\u00a0that the ASSURE clinical trial had failed to meet its primary endpoint. RVX-208, the drug being studied in the trial, is a novel small molecule that increases production of Apolipoprotein A-I (ApoA-1), which raises HDL levels and is thought to enhance reverse cholesterol transport. ASSURE\u00a0was […]<\/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":[209,666,1863],"class_list":["post-37264","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-hdl","tag-ivus","tag-reverse-cholesterol-transport"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/37264","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=37264"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/37264\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=37264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=37264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=37264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}