{"id":4608,"date":"2010-11-14T10:32:09","date_gmt":"2010-11-14T15:32:09","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=4608"},"modified":"2011-07-19T17:44:43","modified_gmt":"2011-07-19T21:44:43","slug":"ascend-hf-nesiritide-is-safe-but-not-effective","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/11\/14\/ascend-hf-nesiritide-is-safe-but-not-effective\/","title":{"rendered":"ASCEND-HF: Nesiritide Is Safe But Not Effective"},"content":{"rendered":"
\n

ASCEND-HF (Acute\u00a0Study of\u00a0Clinical\u00a0Effectiveness of\u00a0Nesiritide in\u00a0Decompensated\u00a0Heart\u00a0Failure Trial) was started in response to the enormous controversy over the safety and efficacy of nesiritide, which was being used in growing numbers of heart failure patients.\u00a0\u00a0The trial randomized 7141 patients with\u00a0acute, decompensated HF to receive standard therapy and either continuous intravenous nesiritide or placebo.<\/p>\n

Results of ASCEND-HF, presented as a late-breaking clinical trial at the AHA meeting, showed that there were no significant differences in the pre-specified endpoint of dyspnea. Shortness of breath improved in 15.0% of nesiritide patients and 13.4% of placebo patients. At 24 hours, the pattern was similar: 30.4% of nesiritide patients and 27.5% of placebo patients had improved \u00a0breathing function. At 1 month, the rate of all-cause mortality and hospital readmission for HF did not differ statistically between the groups (9.4% with nesiritide and 10.1% with placebo).<\/p>\n

Although the early controversy over nesiritide was fueled by concerns that the drug might cause an increase in mortality or renal damage, the ASCEND-HF investigators found no evidence to support these concerns.<\/p>\n

In an AHA press release<\/a>, study chair Robert Califf said:<\/p>\n

\u201cNesiritide was marketed and widely used in the U.S.\u00a0because of a perception that it had a major effect on dyspnea and then largely\u00a0abandoned\u00a0in clinical use because of concerns that it might increase rates of\u00a0death and renal failure. Now that we finally have a proper clinical\u00a0trial we know that both\u00a0perceptions were incorrect; nesiritide is safe but has\u00a0only a modest effect on dyspnea. This is a major signal that we must do a\u00a0better job defining\u00a0the biological effects of drugs early in development and\u00a0conduct adequately powered outcomes trials much earlier to give doctors and\u00a0patients the\u00a0necessary information to enable appropriate use of the treatment\u00a0in practice.\u201d<\/p>\n

Said trial investigator Adrian Hernandez:\u00a0\u201cI think the main message is that we need to do adequately\u00a0powered studies to really understand the balance of safety and effectiveness. Now\u00a0that we\u2019ve\u00a0done an adequate trial, we know that nesiritide can be used safely,\u00a0but there is no mandate to use it because of its modest effects.\u201d<\/p>\n

One investigator, Randall Starling, did not rule out the use of nesiritide in some patients: \u201cGiven the\u00a0complexities of heart failure, there is a significant need for better\u00a0medications for use in treatment. With the safety questions related to nesiritide having now been addressed, it\u00a0could be an option for physicians\u00a0depending on their interpretation of clinical\u00a0benefit.<\/p>\n

Note: The AHA 2010 presentation slides for ASCEND-HF<\/a> can be found on the Duke Clinical Research Institute website.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

ASCEND-HF (Acute\u00a0Study of\u00a0Clinical\u00a0Effectiveness of\u00a0Nesiritide in\u00a0Decompensated\u00a0Heart\u00a0Failure Trial) was started in response to the enormous controversy over the safety and efficacy of nesiritide, which was being used in growing numbers of heart failure patients.\u00a0\u00a0The trial randomized 7141 patients with\u00a0acute, decompensated HF to receive standard therapy and either continuous intravenous nesiritide or placebo. Results of ASCEND-HF, presented as […]<\/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":[549,550,287,305,548],"class_list":["post-4608","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-acute-heart-failure","tag-decompensated-heart-failure","tag-heart-failure-2","tag-hf","tag-nesiritide"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/4608","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=4608"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/4608\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=4608"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=4608"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=4608"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}