Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

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. Corbalan; 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. E. Hollander; J. G. Howlett; M. P. Hudson; R. D. Kociol; H. Krum; A. Laucevicius; W. C. Levy; G. F. Mendez; 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; Joseph A. Hill

Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

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. BohidarJ. Butler, N. Clausell, R. Corbalan, 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. E. Hollander, J. G. Howlett, M. P. Hudson, R. D. Kociol, H. Krum, A. Laucevicius, W. C. Levy, G. F. Mendez, 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, Joseph A. Hill

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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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 Pd

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.

Original language	English
Pages (from-to)	32-43
Number of pages	12
Journal	New England Journal of Medicine
Volume	365
Issue number	1
Publication status	Published - 7-Jul-2011

Keywords

RANDOMIZED CONTROLLED TRIAL
NATIONAL REGISTRY ADHERE
HOSPITALIZED-PATIENTS
OUTCOMES
POPULATION
DIURETICS
RISK

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O'Connor, C. M., Starling, R. C., Hernandez, A. F., Armstrong, P. W., Dickstein, K., Hasselblad, V., Heizer, G. M., Komajda, M., Massie, B. M., McMurray, J. J. V., Nieminen, M. S., Reist, C. J., Rouleau, J. L., Swedberg, K., Adams, K. F., Anker, S. D., Atar, D., Battler, A., Botero, R., ... Hill, J. A. (2011). Effect of Nesiritide in Patients with Acute Decompensated Heart Failure. New England Journal of Medicine, 365(1), 32-43.

@article{0559cf81f59f42c5af6cf1dce6b0549f,

title = "Effect of Nesiritide in Patients with Acute Decompensated Heart Failure",

abstract = "BackgroundNesiritide 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.MethodsWe 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.ResultsPatients 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 PdConclusionsNesiritide 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.",

keywords = "RANDOMIZED CONTROLLED TRIAL, NATIONAL REGISTRY ADHERE, HOSPITALIZED-PATIENTS, OUTCOMES, POPULATION, DIURETICS, RISK",

author = "O'Connor, {C. M.} and Starling, {R. C.} and Hernandez, {A. F.} and Armstrong, {P. W.} and K. Dickstein and V. Hasselblad and Heizer, {G. M.} and M. Komajda and Massie, {B. M.} and McMurray, {J. J. V.} and Nieminen, {M. S.} and Reist, {C. J.} and Rouleau, {J. L.} and K. Swedberg and Adams, {K. F.} and Anker, {S. D.} and D. Atar and A. Battler and R. Botero and Bohidar, {N. R.} and J. Butler and N. Clausell and R. Corbalan and Costanzo, {M. R.} and U. Dahlstrom and Deckelbaum, {L. I.} and R. Diaz and Dunlap, {M. E.} and Ezekowitz, {J. A.} and D. Feldman and Felker, {G. M.} and Fonarow, {G. C.} and D. Gennevois and Gottlieb, {S. S.} and Hollander, {J. E.} and Howlett, {J. G.} and Hudson, {M. P.} and Kociol, {R. D.} and H. Krum and A. Laucevicius and Levy, {W. C.} and Mendez, {G. F.} and M. Metra and S. Mittal and Oh, {B. -H.} and Pereira, {N. L.} and P. Ponikowski and Wilson, {W. H.} and S. Tanomsup and Teerlink, {J. R.} and F. Triposkiadis and Troughton, {R. W.} and Voors, {A. A.} and Whellan, {D. J.} and F. Zannad and Califf, {R. M.} and Hill, {Joseph A.}",

year = "2011",

month = jul,

day = "7",

language = "English",

volume = "365",

pages = "32--43",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOC",

number = "1",

}

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, Corbalan, R, Costanzo, MR, Dahlstrom, U, Deckelbaum, LI, Diaz, R, Dunlap, ME, Ezekowitz, JA, Feldman, D, Felker, GM, Fonarow, GC, Gennevois, D, Gottlieb, SS, Hollander, JE, Howlett, JG, Hudson, MP, Kociol, RD, Krum, H, Laucevicius, A, Levy, WC, Mendez, GF, Metra, M, Mittal, S, Oh, B-H, Pereira, NL, Ponikowski, P, Wilson, WH, Tanomsup, S, Teerlink, JR, Triposkiadis, F, Troughton, RW, Voors, AA, Whellan, DJ, Zannad, F, Califf, RM & Hill, JA 2011, 'Effect of Nesiritide in Patients with Acute Decompensated Heart Failure', New England Journal of Medicine, vol. 365, no. 1, pp. 32-43.

TY - JOUR

T1 - Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

AU - O'Connor, C. M.

AU - Starling, R. C.

AU - Hernandez, A. F.

AU - Armstrong, P. W.

AU - Dickstein, K.

AU - Hasselblad, V.

AU - Heizer, G. M.

AU - Komajda, M.

AU - Massie, B. M.

AU - McMurray, J. J. V.

AU - Nieminen, M. S.

AU - Reist, C. J.

AU - Rouleau, J. L.

AU - Swedberg, K.

AU - Adams, K. F.

AU - Anker, S. D.

AU - Atar, D.

AU - Battler, A.

AU - Botero, R.

AU - Bohidar, N. R.

AU - Butler, J.

AU - Clausell, N.

AU - Corbalan, R.

AU - Costanzo, M. R.

AU - Dahlstrom, U.

AU - Deckelbaum, L. I.

AU - Diaz, R.

AU - Dunlap, M. E.

AU - Ezekowitz, J. A.

AU - Feldman, D.

AU - Felker, G. M.

AU - Fonarow, G. C.

AU - Gennevois, D.

AU - Gottlieb, S. S.

AU - Hollander, J. E.

AU - Howlett, J. G.

AU - Hudson, M. P.

AU - Kociol, R. D.

AU - Krum, H.

AU - Laucevicius, A.

AU - Levy, W. C.

AU - Mendez, G. F.

AU - Metra, M.

AU - Mittal, S.

AU - Oh, B. -H.

AU - Pereira, N. L.

AU - Ponikowski, P.

AU - Wilson, W. H.

AU - Tanomsup, S.

AU - Teerlink, J. R.

AU - Triposkiadis, F.

AU - Troughton, R. W.

AU - Voors, A. A.

AU - Whellan, D. J.

AU - Zannad, F.

AU - Califf, R. M.

AU - Hill, Joseph A.

PY - 2011/7/7

Y1 - 2011/7/7

N2 - BackgroundNesiritide 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.MethodsWe 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.ResultsPatients 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 PdConclusionsNesiritide 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.

AB - BackgroundNesiritide 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.MethodsWe 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.ResultsPatients 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 PdConclusionsNesiritide 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.

KW - RANDOMIZED CONTROLLED TRIAL

KW - NATIONAL REGISTRY ADHERE

KW - HOSPITALIZED-PATIENTS

KW - OUTCOMES

KW - POPULATION

KW - DIURETICS

KW - RISK

M3 - Article

SN - 0028-4793

VL - 365

SP - 32

EP - 43

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 1

ER -

Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

Abstract

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