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Volume 344:1651-1658 May 31, 2001 Number 22 Next

	Full Text PDF Editorial by Braunwald, E. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

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.

Source Information

From the College of Physicians and Surgeons, Columbia University, New York (M.P.); Royal Brompton Hospital, London (A.J.S.C.); Stanford University Medical Center, Stanford, Calif. (M.B.F.); Universitäts Klinikum Lübeck, Lübeck, Germany (H.A.K.); Monash University, Prahran, Victoria, Australia (H.K.); University Hospital, Bern, Switzerland (P.M.); University Health Network and Mount Sinai Hospital, Toronto (J.L.R.); Silesian School of Medicine, Katowice, Poland (M.T.); Hôpital Henri Mondor, Paris (A.C.); and the University of Wisconsin, Madison (E.B.R., M.K.S., D.L.D.).

Other authors were Christoph Staiger, M.D., of Roche Pharmaceuticals, Basel, Switzerland; and Ellen L. Curtin, M.D., of GlaxoSmithKline, Philadelphia.

Address reprint requests to Dr. Packer at the Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, 630 W. 168th St., New York, NY 10032, or at mp65{at}columbia.edu.

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