Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

Cathal O’Connor(University of Namur), Randall C. Starling(University of Namur), Adrian F. Hernandez(University of Namur), Paul W. Armstrong(University of Namur), Kenneth Dickstein(University of Namur), Vic Hasselblad(University of Namur), Gretchen Heizer(University of Namur), Michel Komajda(University of Namur), Barry M. Massie(University of Namur), John J.V. McMurray(University of Namur), Markku S. Nieminen(University of Namur), Craig J. Reist(University of Namur), Jean L. Rouleau(University of Namur), Karl Swedberg(University of Namur), Kirkwood F. Adams(University of Namur), Stefan D. Anker(University of Namur), Dan Atar(University of Namur), A Battler(University of Namur), Rodrigo Botero(University of Namur), N. R. Bohidar(University of Namur), Javed Butler(University of Namur), Nadine Clausell(University of Namur), Ramón Corbalán(University of Namur), Maria Rosa Costanzo(University of Namur), Ulf Dahlström(University of Namur), Lawrence I. Deckelbaum(University of Namur), Rafael Díaz(University of Namur), Mark E. Dunlap(University of Namur), Justin A. Ezekowitz(University of Namur), DO Bruce Feldman(University of Namur), G. Michael Felker(University of Namur), Gregg C. Fonarow(University of Namur), Daniel Gennevois(University of Namur), Stephen S. Gottlieb(University of Namur), James A. Hill(University of Namur), Judd E. Hollander(University of Namur), Jonathan G. Howlett(University of Namur), Michael Hudson(University of Namur), Robb D. Kociol(University of Namur), Henry Krum(University of Namur), Aleksandras Laucevičius(University of Namur), Wayne C. Levy(University of Namur), Gustavo Méndez(University of Namur), Marco Metra(University of Namur), Sanjay Mittal(University of Namur), Byung‐Hee Oh(University of Namur), Naveen L. Pereira(University of Namur), Piotr Ponikowski(University of Namur), W.H. Wilson Tang(University of Namur), Supachai Tanomsup(University of Namur), John R. Teerlink(University of Namur), F. Triposkiadis(University of Namur), Richard W. Troughton(University of Namur), Adriaan A. Voors(University of Namur), David J. Whellan(University of Namur), Faı̈ez Zannad(University of Namur), Robert M. Califf(University of Namur)
New England Journal of Medicine
July 6, 2011
10.1056/nejmoa1100171
Cited by 1,233Open Access
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Abstract

BACKGROUND: Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. METHODS: We randomly assigned 7141 patients who were hospitalized with acute heart failure to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care. Coprimary end points were the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, and the composite end point of rehospitalization for heart failure or death within 30 days. RESULTS: Patients randomly assigned to nesiritide, as compared with those assigned to placebo, more frequently reported markedly or moderately improved dyspnea at 6 hours (44.5% vs. 42.1%, P=0.03) and 24 hours (68.2% vs. 66.1%, P=0.007), but the prespecified level for significance (P≤0.005 for both assessments or P≤0.0025 for either) was not met. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.1 to 0.7; P=0.31). There were no significant differences in rates of death from any cause at 30 days (3.6% with nesiritide vs. 4.0% with placebo; absolute difference, -0.4 percentage points; 95% CI, -1.3 to 0.5) or rates of worsening renal function, defined by more than a 25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds ratio, 1.09; 95% CI, 0.98 to 1.21; P=0.11). CONCLUSIONS: Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.).

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