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Title: Effect of nesiritide in patients with acute decompensated heart failure
Authors: C. M. O'Connor
R. C. Starling
A. F. Hernandez
P. W. Armstrong
K. Dickstein
V. Hasselblad
G. M. Heizer
M. Komajda
B. M. Massie
J. J.V. McMurray
M. S. Nieminen
C. J. Reist
J. L. Rouleau
K. Swedberg
K. F. Adams
S. D. Anker
D. Atar
A. Battler
R. Botero
N. R. Bohidar
J. Butler
N. Clausell
R. Corbalán
M. R. Costanzo
U. Dahlstrom
L. I. Deckelbaum
R. Diaz
M. E. Dunlap
J. A. Ezekowitz
D. Feldman
G. M. Felker
G. C. Fonarow
D. Gennevois
S. S. Gottlieb
J. A. Hill
J. E. Hollander
J. G. Howlett
M. P. Hudson
R. D. Kociol
H. Krum
A. Laucevicius
W. C. Levy
G. F. Méndez
M. Metra
S. Mittal
B. H. Oh
N. L. Pereira
P. Ponikowski
W. H. Wilson
S. Tanomsup
J. R. Teerlink
F. Triposkiadis
R. W. Troughton
A. A. Voors
D. J. Whellan
F. Zannad
R. M. Califf
Duke Clinical Research Institute
The University of North Carolina at Chapel Hill
Cleveland Clinic
MetroHealth Medical Center
University of Alberta
Institut de Cardiologie de Montreal
Dalhousie University
Stavanger University Hospital
Universite Pierre et Marie Curie
University of California, San Francisco
VA Medical Center
University of Glasgow
Meilahti Hospital
Goteborgs Universitet
Linkopings universitet
IRCCS San Raffaele Pisana
Charite - Universitatsmedizin Berlin
Aker University Hospital
Rabin Medical Center Israel
Clínica Medellín
Johnson & Johnson Pharmaceutical Research & Development, Raritan
Emory University
Hospital de Clinicas de Porto Alegre
Pontificia Universidad Catolica de Chile
Midwest Heart Specialists
Estudios Clínicos Latino America and Instituto Cardiovascular de Rosario
Minneapolis Heart Institute
Ronald Reagan UCLA Medical Center
Janssen Alzheimer Immunotherapy
University of Maryland Medical Center
University of Florida
University of Pennsylvania
Jefferson Medical College
Edith and Benson Ford Heart and Vascular Institute
Monash University
Vilniaus universitetas
University of Washington Medical Center
Instituto Mexicano del Seguro Social
Universita degli Studi di Brescia
Escorts Heart Institute and Research Centre India
Seoul National University Hospital
Mayo Clinic
Akademia Medyczna Wroclawiu
Mahidol University
University Hospital of Larissa
University of Otago
University of Groningen, University Medical Center Groningen
CHU de Nancy
Keywords: Medicine
Issue Date: 7-Jul-2011
Citation: New England Journal of Medicine. Vol.365, No.1 (2011), 32-43
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; number, NCT00475852.) Copyright © 2011 Massachusetts Medical Society.
ISSN: 15334406
Appears in Collections:Scopus 2011-2015

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