Effect of carvedilol on survival in severe chronic heart failure

Milton Packer, Andrew J S Coats, Michael B. Fowler, Hugo A. Katus, Henry Krum, Paul Mohacsi, Jean L. Rouleau, Michal Tendera, Alain Castaigne, Ellen B. Roecker, Melissa K. Schultz, David L. DeMets

Research output: Contribution to journalArticle

2471 Citations (Scopus)

Abstract

Background: Beta-blocking agents reduce the risk of hospitalization and death in patients with mild-to-moderate heart failure, but little is known about their effects in severe heart failure. Methods: We evaluated 2289 patients who had symptoms of heart failure at rest or on minimal exertion, who were clinically euvolemic, and who had an ejection fraction of less than 25 percent. In a double-blind fashion, we randomly assigned 1133 patients to placebo and 1156 patients to treatment with carvedilol for a mean period of 10.4 months, during which standard therapy for heart failure was continued. Patients who required intensive care, had marked fluid retention, or were receiving intravenous vasodilators or positive inotropic drugs were excluded. Results: There were 190 deaths in the placebo group and 130 deaths in the carvedilol group. This difference reflected a 35 percent decrease in the risk of death with carvedilol (95 percent confidence interval, 19 to 48 percent; P=0.0014, adjusted for interim analyses). A total of 507 patients died or were hospitalized in the placebo group, as compared with 425 in the carvedilol group. This difference reflected a 24 percent decrease in the combined risk of death or hospitalization with carvedilol. The favorable effects on both end points were seen consistently in all the subgroups we examined. Fewer patients in the carvedilol group than in the placebo group withdrew because of adverse effects or for other reasons (P=0.02). Conclusions: The previously reported benefits of carvedilol with regard to morbidity and mortality in patients with mild-to-moderate heart failure were also found in the patients with severe heart failure who were evaluated in this trial.

Original languageEnglish (US)
Pages (from-to)1651-1658
Number of pages8
JournalNew England Journal of Medicine
Volume344
Issue number22
DOIs
StatePublished - May 31 2001

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Heart Failure
Survival
Placebos
Hospitalization
carvedilol
Critical Care
Vasodilator Agents
Confidence Intervals
Morbidity
Mortality
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Packer, M., Coats, A. J. S., Fowler, M. B., Katus, H. A., Krum, H., Mohacsi, P., ... DeMets, D. L. (2001). Effect of carvedilol on survival in severe chronic heart failure. New England Journal of Medicine, 344(22), 1651-1658. https://doi.org/10.1056/NEJM200105313442201

Effect of carvedilol on survival in severe chronic heart failure. / Packer, Milton; Coats, Andrew J S; Fowler, Michael B.; Katus, Hugo A.; Krum, Henry; Mohacsi, Paul; Rouleau, Jean L.; Tendera, Michal; Castaigne, Alain; Roecker, Ellen B.; Schultz, Melissa K.; DeMets, David L.

In: New England Journal of Medicine, Vol. 344, No. 22, 31.05.2001, p. 1651-1658.

Research output: Contribution to journalArticle

Packer, M, Coats, AJS, Fowler, MB, Katus, HA, Krum, H, Mohacsi, P, Rouleau, JL, Tendera, M, Castaigne, A, Roecker, EB, Schultz, MK & DeMets, DL 2001, 'Effect of carvedilol on survival in severe chronic heart failure', New England Journal of Medicine, vol. 344, no. 22, pp. 1651-1658. https://doi.org/10.1056/NEJM200105313442201
Packer M, Coats AJS, Fowler MB, Katus HA, Krum H, Mohacsi P et al. Effect of carvedilol on survival in severe chronic heart failure. New England Journal of Medicine. 2001 May 31;344(22):1651-1658. https://doi.org/10.1056/NEJM200105313442201
Packer, Milton ; Coats, Andrew J S ; Fowler, Michael B. ; Katus, Hugo A. ; Krum, Henry ; Mohacsi, Paul ; Rouleau, Jean L. ; Tendera, Michal ; Castaigne, Alain ; Roecker, Ellen B. ; Schultz, Melissa K. ; DeMets, David L. / Effect of carvedilol on survival in severe chronic heart failure. In: New England Journal of Medicine. 2001 ; Vol. 344, No. 22. pp. 1651-1658.
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AU - Coats, Andrew J S

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AU - Krum, Henry

AU - Mohacsi, Paul

AU - Rouleau, Jean L.

AU - Tendera, Michal

AU - Castaigne, Alain

AU - Roecker, Ellen B.

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AU - DeMets, David L.

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N2 - Background: Beta-blocking agents reduce the risk of hospitalization and death in patients with mild-to-moderate heart failure, but little is known about their effects in severe heart failure. Methods: We evaluated 2289 patients who had symptoms of heart failure at rest or on minimal exertion, who were clinically euvolemic, and who had an ejection fraction of less than 25 percent. In a double-blind fashion, we randomly assigned 1133 patients to placebo and 1156 patients to treatment with carvedilol for a mean period of 10.4 months, during which standard therapy for heart failure was continued. Patients who required intensive care, had marked fluid retention, or were receiving intravenous vasodilators or positive inotropic drugs were excluded. Results: There were 190 deaths in the placebo group and 130 deaths in the carvedilol group. This difference reflected a 35 percent decrease in the risk of death with carvedilol (95 percent confidence interval, 19 to 48 percent; P=0.0014, adjusted for interim analyses). A total of 507 patients died or were hospitalized in the placebo group, as compared with 425 in the carvedilol group. This difference reflected a 24 percent decrease in the combined risk of death or hospitalization with carvedilol. The favorable effects on both end points were seen consistently in all the subgroups we examined. Fewer patients in the carvedilol group than in the placebo group withdrew because of adverse effects or for other reasons (P=0.02). Conclusions: The previously reported benefits of carvedilol with regard to morbidity and mortality in patients with mild-to-moderate heart failure were also found in the patients with severe heart failure who were evaluated in this trial.

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