{"id":31993,"date":"2012-09-25T10:53:52","date_gmt":"2012-09-25T14:53:52","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=31993"},"modified":"2012-09-25T10:53:52","modified_gmt":"2012-09-25T14:53:52","slug":"novartis-announces-top-line-results-for-phase-3-trial-of-new-acute-heart-failure-drug","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/09\/25\/novartis-announces-top-line-results-for-phase-3-trial-of-new-acute-heart-failure-drug\/","title":{"rendered":"Novartis Announces Top Line Results for Phase 3 Trial of New Acute Heart Failure Drug"},"content":{"rendered":"<p>Novartis has <a href=\"http:\/\/pharmalive.com\/news\/index.cfm?articleID=858535&amp;categoryid=9&amp;newsletter=1\">announced<\/a>\u00a0preliminary results from the\u00a0<a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00520806?term=relax-ahf&amp;rank=1\">RELAX-AHF<\/a>\u00a0trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea.<\/p>\n<p>Novartis also reported a reduction in all-cause mortality at 6 months. However, it should be noted that the predefined secondary endpoint on\u00a0<a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00520806?term=relax-ahf&amp;rank=1\">ClinicalTrials.Gov<\/a>\u00a0was mortality at 60 days, not 6 months. (CardioExchange has requested clarification from Novartis about this point.)<\/p>\n<p>In the trial, 1161 patients hospitalized with acute heart failure were randomized to placebo or an IV infusion of RLX030 for up to 48 hours.\u00a0 By\u00a0<a href=\"http:\/\/www.ahjonline.com\/article\/S0002-8703(11)00724-1\/abstract\">design<\/a>, the trial had two primary efficacy endpoints measuring dyspnea, but only one of them reached statistical significance, according to the company.<\/p>\n<p>The full results of RELAX-AHF are scheduled to be presented as a late-breaking clinical trial at the American Heart Association meeting in Los Angeles in November.<\/p>\n<p>RLX030 is a recombinant form of the naturally occurring human hormone relaxin-2. The drug was originally developed by Corthera, Inc, which was acquired by Novartis in February 2010.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis has announced\u00a0preliminary results from the\u00a0RELAX-AHF\u00a0trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all-cause mortality at 6 months. However, it should be noted that [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[549,322,1473,1476,1474,1475],"class_list":["post-31993","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-acute-heart-failure","tag-dyspnea","tag-relax-ahf","tag-relaxin-2","tag-rlx030","tag-serelaxin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31993","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=31993"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31993\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31993"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31993"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31993"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}