{"id":9178,"date":"2011-07-07T14:17:56","date_gmt":"2011-07-07T18:17:56","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=9178"},"modified":"2011-07-19T17:44:21","modified_gmt":"2011-07-19T21:44:21","slug":"ascend-hf-no-harm-or-benefit-with-nesiritide","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/07\/07\/ascend-hf-no-harm-or-benefit-with-nesiritide\/","title":{"rendered":"ASCEND-HF: No Harm or Benefit with Nesiritide"},"content":{"rendered":"<p>With the publication of <a href=\"http:\/\/www.nejm.org\/doi\/pdf\/10.1056\/NEJMoa1100171\">the final results of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial in the<\/a><a href=\"http:\/\/www.nejm.org\/doi\/pdf\/10.1056\/NEJMoa1100171\"><em> New England Journal of Medicine<\/em><\/a>, the once intense controversy over the use &#8212; or misuse &#8212; of the drug nesiritide in patients with acute decompensated heart failure has finally been resolved. The results, which were <a title=\"ASCEND-HF: Nesiritide Is Safe But Not Effective\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/ascend-hf-nesiritide-is-safe-but-not-effective\/\">first presented last November at the AHA<\/a>, demonstrate unequivocally that the drug was neither harmful nor beneficial.<\/p>\n<p>CM O&#8217;Connor and colleagues randomized 7,141 patients with acute HF to either nesiritide or placebo. The primary endpoin t&#8211; the rate of rehospitalization or death within 30 days &#8212; occurred in 9.4% of patients in the nesiritide group versus  10.1% of patients in the placebo group (CI \u22122.1 to 0.7, p=0.31).<\/p>\n<p>The investigators concluded that &#8220;on the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure.&#8221; Noting the early widespread use of the drug despite the lack of evidence, the authors wrote that &#8220;the results of this trial highlight the urgent need for rigorously designed trials with adequate power to provide reliable estimates that can replace incomplete or inadequate evidence as a basis for therapeutic decisions.&#8221;<\/p>\n<p>In <a href=\"http:\/\/www.nejm.org\/doi\/pdf\/10.1056\/NEJMe1103116\">an accompanying editorial<\/a>, Eric Topol writes about the &#8220;lost decade&#8221; from the time of FDA approval of nesiritide to the publication of the trial, in which &#8220;well more than $1 billion was wasted on purchasing the drug.&#8221;<\/p>\n<p>After the presentation last November of the initial trial results, <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/ascending-into-the-depths-of-the-nesiritide-controversy\/?utm_source=pfw&amp;utm_medium=email&amp;utm_campaign=pfwpromo-07072011\">Eugene Braunwald told CardioExchange<\/a>: &#8220;I don&#8217;t see much of a future for nesiritide.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the publication of the final results of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial in the New England Journal of Medicine, the once intense controversy over the use &#8212; or misuse &#8212; of the drug nesiritide in patients with acute decompensated heart failure has finally been resolved. [&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":[899,900,548],"class_list":["post-9178","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-acute-decompensated-heart-failure","tag-adhf","tag-nesiritide"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/9178","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=9178"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/9178\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=9178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=9178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=9178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}