Effect of nesiritide in patients with acute decompensated heart failure
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/189579 |
Resumo: | 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. |
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O'Connor, Christopher M.Starling, Randall C.Hernandez, Adrian F.Armstrong, Paul W.Dickstein, K.Hasselblad, V.Heizer, Gretchen M.Komajda, MichelMassie, Barry M.McMurray, John J. V.Nieminen, Markku S.Reist, C.J.Rouleau, J.L.Swedberg, KarlAdams Junior, K.F.Anker, S.D.Atar, D.Battler, A.Botero, R.Bohidar, N.R.Butler, J.Clausell, Nadine OliveiraCorbalan, RamonCostanzo, Maria RosaDahlstrom, U.Deckelbaum, L.I.Diaz, R.Dunlap, Mark E.Ezekowitz, Justin A.Feldman, D.Felker, G.M.Fonarow, G.C.Gennevois, D.Gottlieb, S.S.Hill, J.A.Hollander, J.E.Howlett, Jonathan G.Hudson, M.P.Kociol, R.D.Krum, HenryLaucevicius, A.Levy, W.C.Méndez, G.F.Metra, MarcoMittal, S.Oh, B.H.Pereira, N.L.Ponikowski, P.Tang, W.H.W.Tanomsup, S.Teerlink, John R.Triposkiadis, F.Troughton, R.W.Voors, Adriaan A.Whellan, D.J.Zannad, F.Califf, Robert M.2019-03-27T04:06:04Z20110028-4793http://hdl.handle.net/10183/189579000821314Background 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.application/pdfengThe New England journal of medicine. Boston. Vol. 365, no. 1 (July 2011), p. 32-43.Peptídeo natriurético encefálicoInsuficiência cardíacaEffect of nesiritide in patients with acute decompensated heart failureEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT000821314.pdf.txt000821314.pdf.txtExtracted Texttext/plain49753http://www.lume.ufrgs.br/bitstream/10183/189579/2/000821314.pdf.txt9b4bd1dd101f2055becc7e89aa397cefMD52ORIGINAL000821314.pdfTexto completo (inglês)application/pdf449639http://www.lume.ufrgs.br/bitstream/10183/189579/1/000821314.pdfff4b1d54a65bad5de51a6aff1ef78439MD5110183/1895792024-08-10 06:32:38.476274oai:www.lume.ufrgs.br:10183/189579Repositório InstitucionalPUBhttps://lume.ufrgs.br/oai/requestlume@ufrgs.bropendoar:2024-08-10T09:32:38Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Effect of nesiritide in patients with acute decompensated heart failure |
title |
Effect of nesiritide in patients with acute decompensated heart failure |
spellingShingle |
Effect of nesiritide in patients with acute decompensated heart failure O'Connor, Christopher M. Peptídeo natriurético encefálico Insuficiência cardíaca |
title_short |
Effect of nesiritide in patients with acute decompensated heart failure |
title_full |
Effect of nesiritide in patients with acute decompensated heart failure |
title_fullStr |
Effect of nesiritide in patients with acute decompensated heart failure |
title_full_unstemmed |
Effect of nesiritide in patients with acute decompensated heart failure |
title_sort |
Effect of nesiritide in patients with acute decompensated heart failure |
author |
O'Connor, Christopher M. |
author_facet |
O'Connor, Christopher M. Starling, Randall C. Hernandez, Adrian F. Armstrong, Paul W. Dickstein, K. Hasselblad, V. Heizer, Gretchen M. Komajda, Michel Massie, Barry M. McMurray, John J. V. Nieminen, Markku S. Reist, C.J. Rouleau, J.L. Swedberg, Karl Adams Junior, K.F. Anker, S.D. Atar, D. Battler, A. Botero, R. Bohidar, N.R. Butler, J. Clausell, Nadine Oliveira Corbalan, Ramon Costanzo, Maria Rosa Dahlstrom, U. Deckelbaum, L.I. Diaz, R. Dunlap, Mark E. Ezekowitz, Justin A. Feldman, D. Felker, G.M. Fonarow, G.C. Gennevois, D. Gottlieb, S.S. Hill, J.A. Hollander, J.E. Howlett, Jonathan G. Hudson, M.P. Kociol, R.D. Krum, Henry Laucevicius, A. Levy, W.C. Méndez, G.F. Metra, Marco Mittal, S. Oh, B.H. Pereira, N.L. Ponikowski, P. Tang, W.H.W. Tanomsup, S. Teerlink, John R. Triposkiadis, F. Troughton, R.W. Voors, Adriaan A. Whellan, D.J. Zannad, F. Califf, Robert M. |
author_role |
author |
author2 |
Starling, Randall C. Hernandez, Adrian F. Armstrong, Paul W. Dickstein, K. Hasselblad, V. Heizer, Gretchen M. Komajda, Michel Massie, Barry M. McMurray, John J. V. Nieminen, Markku S. Reist, C.J. Rouleau, J.L. Swedberg, Karl Adams Junior, K.F. Anker, S.D. Atar, D. Battler, A. Botero, R. Bohidar, N.R. Butler, J. Clausell, Nadine Oliveira Corbalan, Ramon Costanzo, Maria Rosa Dahlstrom, U. Deckelbaum, L.I. Diaz, R. Dunlap, Mark E. Ezekowitz, Justin A. Feldman, D. Felker, G.M. Fonarow, G.C. Gennevois, D. Gottlieb, S.S. Hill, J.A. Hollander, J.E. Howlett, Jonathan G. Hudson, M.P. Kociol, R.D. Krum, Henry Laucevicius, A. Levy, W.C. Méndez, G.F. Metra, Marco Mittal, S. Oh, B.H. Pereira, N.L. Ponikowski, P. Tang, W.H.W. Tanomsup, S. Teerlink, John R. Triposkiadis, F. Troughton, R.W. Voors, Adriaan A. Whellan, D.J. Zannad, F. Califf, Robert M. |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
O'Connor, Christopher M. Starling, Randall C. Hernandez, Adrian F. Armstrong, Paul W. Dickstein, K. Hasselblad, V. Heizer, Gretchen M. Komajda, Michel Massie, Barry M. McMurray, John J. V. Nieminen, Markku S. Reist, C.J. Rouleau, J.L. Swedberg, Karl Adams Junior, K.F. Anker, S.D. Atar, D. Battler, A. Botero, R. Bohidar, N.R. Butler, J. Clausell, Nadine Oliveira Corbalan, Ramon Costanzo, Maria Rosa Dahlstrom, U. Deckelbaum, L.I. Diaz, R. Dunlap, Mark E. Ezekowitz, Justin A. Feldman, D. Felker, G.M. Fonarow, G.C. Gennevois, D. Gottlieb, S.S. Hill, J.A. Hollander, J.E. Howlett, Jonathan G. Hudson, M.P. Kociol, R.D. Krum, Henry Laucevicius, A. Levy, W.C. Méndez, G.F. Metra, Marco Mittal, S. Oh, B.H. Pereira, N.L. Ponikowski, P. Tang, W.H.W. Tanomsup, S. Teerlink, John R. Triposkiadis, F. Troughton, R.W. Voors, Adriaan A. Whellan, D.J. Zannad, F. Califf, Robert M. |
dc.subject.por.fl_str_mv |
Peptídeo natriurético encefálico Insuficiência cardíaca |
topic |
Peptídeo natriurético encefálico Insuficiência cardíaca |
description |
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. |
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2011 |
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2011 |
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The New England journal of medicine. Boston. Vol. 365, no. 1 (July 2011), p. 32-43. |
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