Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

被引：920

作者：

O'Connor, C. M. ^{[1
]}

Starling, R. C. ^{[3
]}

Hernandez, A. F. ^{[1
]}

Armstrong, P. W. ^{[6
]}

Dickstein, K. ^{[8
]}

Hasselblad, V. ^{[1
]}

Heizer, G. M. ^{[1
]}

Komajda, M. ^{[9
,10
]}

Massie, B. M. ^{[11
,12
]}

McMurray, J. J. V. ^{[13
]}

Nieminen, M. S. ^{[14
]}

Reist, C. J. ^{[1
]}

Rouleau, J. L. ^{[5
]}

Swedberg, K. ^{[15
]}

Adams, K. F., Jr. ^{[2
]}

Anker, S. D. ^{[17
,18
]}

Atar, D. ^{[19
]}

Battler, A. ^{[20
]}

Botero, R. ^{[21
]}

Bohidar, N. R. ^{[22
]}

Butler, J. ^{[23
]}

Clausell, N. ^{[24
]}

Corbalan, R. ^{[25
]}

Costanzo, M. R. ^{[26
]}

Dahlstrom, U. ^{[16
]}

Deckelbaum, L. I. ^{[22
]}

Diaz, R. ^{[27
]}

Dunlap, M. E. ^{[4
]}

Ezekowitz, J. A. ^{[6
]}

Feldman, D. ^{[29
]}

Felker, G. M. ^{[1
]}

Fonarow, G. C. ^{[28
]}

Gennevois, D. ^{[30
]}

Gottlieb, S. S. ^{[31
]}

Hill, J. A. ^{[32
]}

Hollander, J. E. ^{[33
]}

Howlett, J. G. ^{[7
]}

Hudson, M. P. ^{[35
]}

Kociol, R. D. ^{[1
]}

Krum, H. ^{[36
,37
]}

Laucevicius, A. ^{[38
]}

Levy, W. C. ^{[39
]}

Mendez, G. F. ^{[40
]}

Metra, M. ^{[41
]}

Mittal, S. ^{[42
]}

Oh, B. -H. ^{[43
]}

Pereira, N. L. ^{[44
]}

Ponikowski, P. ^{[45
]}

Wilson, W. H. ^{[3
]}

Tanomsup, S. ^{[46
]}

机构：

[1] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA

[2] Univ N Carolina, Heart Failure Program, Chapel Hill, NC USA

[3] Cleveland Clin, Cleveland, OH USA

[4] MetroHlth Med Ctr, Heart & Vasc Ctr, Cleveland, OH USA

[5] Univ Montreal, Montreal Heart Inst, Montreal, PQ, Canada

[6] Univ Alberta, Edmonton, AB, Canada

[7] Dalhousie Univ, Halifax, NS, Canada

[8] Univ Bergen, Stavenger Univ Hosp, Bergen, Norway

[9] Univ Paris 06, Paris, France

[10] Hop La Pitie Salpetriere, Paris, France

[11] Univ Calif San Francisco, San Francisco Vet Affairs VA Hosp, San Francisco, CA 94143 USA

[12] San Francisco VA Med Ctr, San Francisco, CA USA

[13] Univ Glasgow, Western Infirm, Glasgow G11 6NT, Lanark, Scotland

[14] Meilahti Hosp, Helsinki, Finland

[15] Univ Gothenburg, Dept Emergency & Cardiovasc Med, Gothenburg, Sweden

[16] Linkoping Univ, Div Cardiovasc Med, Dept Med & Hlth Sci, Linkoping, Sweden

[17] IRCCS, Ctr Clin & Basic Res, Rome, Italy

[18] Charite, Dept Cardiol, D-13353 Berlin, Germany

[19] Aker Univ Hosp, Oslo, Norway

[20] Rabin Med Ctr, Dept Cardiol, Petah Tiqwa, Israel

[21] Clin Medellin, Medellin, Colombia

[22] Johnson & Johnson Pharmaceut Res & Dev, Raritan, NJ USA

[23] Emory Univ, Div Cardiol, Atlanta, GA 30322 USA

[24] Hosp Clin Porto Alegre, Serv Cardiol, Porto Alegre, RS, Brazil

[25] Pontificia Univ Catolica Chile, Div Cardiovasc, Santiago, Chile

[26] Edward Heart Hosp, Naperville, IL USA

[27] Estudios Cardiol Latino Amer, Rosario, Santa Fe, Argentina

[28] Ronald Reagan UCLA Med Ctr, Ahmanson UCLA Cardiomyopathy Ctr, Los Angeles, CA USA

[29] Minneapolis Heart Inst, Minneapolis, MN USA

[30] Janssen Alzheimer Immunotherapy, San Francisco, CA USA

[31] Univ Maryland Hosp, Div Cardiol, Baltimore, MD 21201 USA

[32] Univ Florida, Gainesville, FL USA

[33] Univ Penn, Dept Emergency Med, Philadelphia, PA 19104 USA

[34] Thomas Jefferson Univ, Jefferson Med Coll, Div Cardiol, Philadelphia, PA 19107 USA

[35] Edith & Benson Ford Heart & Vasc Inst, Detroit, MI USA

[36] Monash Univ, Prahran, Vic, Australia

[37] Alfred Hosp, Dept Epidemiol & Prevent Med, Prahran, Vic, Australia

[38] Vilnius Univ Hosp, Santariskiu Klin, Dept Cardiol & Angiol, Vilnius, Lithuania

[39] Univ Washington, Med Ctr, Seattle, WA 98195 USA

[40] Alta Especialidad Hosp Especialidades, Inst Mexicano Seguro Social 14, Unidades Med, Cordoba, Veracruz, Mexico

[41] Univ Brescia, Dept Cardiol, Brescia, Italy

[42] Escorts Heart Inst & Res Ctr, Dept Cardiol, New Delhi, India

[43] Seoul Natl Univ, Coll Med, Dept Internal Med, Seoul Natl Univ Hosp, Seoul 151, South Korea

[44] Mayo Clin, Rochester, MN USA

[45] Med Univ, Dept Heart Dis, Wroclaw, Poland

[46] Mahidol Univ, Ramathibodi Hosp, Fac Med, Div Cardiol, Bangkok 10400, Thailand

[47] Univ Hosp Larissa, Dept Cardiol, Larisa, Greece

[48] Univ Otago, Christchurch, New Zealand

[49] Univ Groningen, Univ Med Ctr Groningen, NL-9713 AV Groningen, Netherlands

[50] Ctr Hosp Univ, INSERM, Ctr Invest Clin 9501, Nancy, France

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2011年 / 365卷 / 01期

关键词：

HOSPITALIZED-PATIENTS; OUTCOMES; DIURETICS; RISK;

D O I：

10.1056/NEJMoa1100171

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 <= 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.

引用

页码：32 / 43

页数：12

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