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Effect of nesiritide in patients with acute decompensated heart failure.

Publication ,  Journal Article
O'Connor, CM; Starling, RC; Hernandez, AF; Armstrong, PW; Dickstein, K; Hasselblad, V; Heizer, GM; Komajda, M; Massie, BM; McMurray, JJV ...
Published in: N Engl J Med
July 7, 2011

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 7, 2011

Volume

365

Issue

1

Start / End Page

32 / 43

Location

United States

Related Subject Headings

  • Recurrence
  • Patient Readmission
  • Natriuretic Peptide, Brain
  • Natriuretic Agents
  • Middle Aged
  • Male
  • Kidney Diseases
  • Intention to Treat Analysis
  • Hypotension
  • Humans
 

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O’Connor, C. M., Starling, R. C., Hernandez, A. F., Armstrong, P. W., Dickstein, K., Hasselblad, V., … Califf, R. M. (2011). Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med, 365(1), 32–43. https://doi.org/10.1056/NEJMoa1100171
O’Connor, C. M., R. C. Starling, A. F. Hernandez, P. W. Armstrong, K. Dickstein, V. Hasselblad, G. M. Heizer, et al. “Effect of nesiritide in patients with acute decompensated heart failure.N Engl J Med 365, no. 1 (July 7, 2011): 32–43. https://doi.org/10.1056/NEJMoa1100171.
O’Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, et al. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32–43.
O’Connor, C. M., et al. “Effect of nesiritide in patients with acute decompensated heart failure.N Engl J Med, vol. 365, no. 1, July 2011, pp. 32–43. Pubmed, doi:10.1056/NEJMoa1100171.
O’Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJV, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh B-H, Pereira NL, Ponikowski P, Tang WHW, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32–43.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 7, 2011

Volume

365

Issue

1

Start / End Page

32 / 43

Location

United States

Related Subject Headings

  • Recurrence
  • Patient Readmission
  • Natriuretic Peptide, Brain
  • Natriuretic Agents
  • Middle Aged
  • Male
  • Kidney Diseases
  • Intention to Treat Analysis
  • Hypotension
  • Humans