Background The role of cardiac glycosides in treating patientswith chronic heart failure and normal sinus rhythm remains controversial.We studied the effect of digoxin on mortality and hospitalizationin a randomized, double-blind clinical trial.
Methods In the main trial, patients with left ventricular ejectionfractions of 0.45 or less were randomly assigned to digoxin(3397 patients) or placebo (3403 patients) in addition to diureticsand angiotensin-converting–enzyme inhibitors (median doseof digoxin, 0.25 mg per day; average follow-up, 37 months).In an ancillary trial of patients with ejection fractions greaterthan 0.45, 492 patients were randomly assigned to digoxin and496 to placebo.
Results In the main trial, mortality was unaffected. There were1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1percent) with placebo (risk ratio when digoxin was comparedwith placebo, 0.99; 95 percent confidence interval, 0.91 to1.07; P = 0.80). In the digoxin group, there was a trend towarda decrease in the risk of death attributed to worsening heartfailure (risk ratio, 0.88; 95 percent confidence interval, 0.77to 1.01; P = 0.06). There were 6 percent fewer hospitalizationsoverall in that group than in the placebo group, and fewer patientswere hospitalized for worsening heart failure (26.8 percentvs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval,0.66 to 0.79; P<0.001). In the ancillary trial, the findingsregarding the primary combined outcome of death or hospitalizationdue to worsening heart failure were consistent with the resultsof the main trial.
Conclusions Digoxin did not reduce overall mortality, but itreduced the rate of hospitalization both overall and for worseningheart failure. These findings define more precisely the roleof digoxin in the management of chronic heart failure.
Source Information
Rekha Garg, M.D., Richard Gorlin, M.D., Thomas Smith, M.D., and Salim Yusuf, M.D., assume responsibility for the contents of this article on behalf of the Digitalis Investigation Group.
Address reprint requests to Dr. Gorlin at Mount Sinai Medical Center, Box 1018, 1 Gustave L. Levy Pl., New York, NY 10029-6574.
Digoxin in Patients with Heart Failure
Umans V. A., Cornel J. H., Hic C., Soto J., Avendaño C., Vilchez F. G., Böhm M., Zoneraich S., Yusuf S., Gorlin R., Garg R., Packer M.
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N Engl J Med 1997;
337:129-131, Jul 10, 1997.
Correspondence
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