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The effect of digoxin on mortality and morbidity in patients with heart failure.
N Engl J Med 1997; 336(8):525-33NEJM

Abstract

BACKGROUND

The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial. We studied the effect of digoxin on mortality and hospitalization in a randomized, double-blind clinical trial.

METHODS

In the main trial, patients with a left ventricular ejection fraction of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and angiotensin-converting-enzyme inhibitors (median dose of digoxin, 0.25 mg per day; average follow-up, 37 months). In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo.

RESULTS

In the main trial, mortality was unaffected. There were 1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1 percent) with placebo (risk ratio when digoxin was compared with placebo, 0.99; 95 percent confidence interval, 0.91 to 1.07; P=0.80). In the digoxin group, there was a trend toward a decrease in the risk of death attributed to worsening heart failure (risk ratio, 0.88; 95 percent confidence interval, 0.77 to 1.01; P=0.06). There were 6 percent fewer hospitalizations overall in that group than in the placebo group, and fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval, 0.66 to 0.79; P<0.001). In the ancillary trial, the findings regarding the primary combined outcome of death or hospitalization due to worsening heart failure were consistent with the results of the main trial.

CONCLUSIONS

Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure. These findings define more precisely the role of digoxin in the management of chronic heart failure.

Authors+Show Affiliations

Mount Sinai Medical Center, New York, NY 10029-6574, USA.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9036306

Citation

Digitalis Investigation Group. "The Effect of Digoxin On Mortality and Morbidity in Patients With Heart Failure." The New England Journal of Medicine, vol. 336, no. 8, 1997, pp. 525-33.
Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997;336(8):525-33.
Digitalis Investigation Group. (1997). The effect of digoxin on mortality and morbidity in patients with heart failure. The New England Journal of Medicine, 336(8), pp. 525-33.
Digitalis Investigation Group. The Effect of Digoxin On Mortality and Morbidity in Patients With Heart Failure. N Engl J Med. 1997 Feb 20;336(8):525-33. PubMed PMID: 9036306.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of digoxin on mortality and morbidity in patients with heart failure. A1 - ,, PY - 1997/2/20/pubmed PY - 1997/2/20/medline PY - 1997/2/20/entrez SP - 525 EP - 33 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 336 IS - 8 N2 - BACKGROUND: The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial. We studied the effect of digoxin on mortality and hospitalization in a randomized, double-blind clinical trial. METHODS: In the main trial, patients with a left ventricular ejection fraction of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and angiotensin-converting-enzyme inhibitors (median dose of digoxin, 0.25 mg per day; average follow-up, 37 months). In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. RESULTS: In the main trial, mortality was unaffected. There were 1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1 percent) with placebo (risk ratio when digoxin was compared with placebo, 0.99; 95 percent confidence interval, 0.91 to 1.07; P=0.80). In the digoxin group, there was a trend toward a decrease in the risk of death attributed to worsening heart failure (risk ratio, 0.88; 95 percent confidence interval, 0.77 to 1.01; P=0.06). There were 6 percent fewer hospitalizations overall in that group than in the placebo group, and fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval, 0.66 to 0.79; P<0.001). In the ancillary trial, the findings regarding the primary combined outcome of death or hospitalization due to worsening heart failure were consistent with the results of the main trial. CONCLUSIONS: Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure. These findings define more precisely the role of digoxin in the management of chronic heart failure. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/9036306/The_effect_of_digoxin_on_mortality_and_morbidity_in_patients_with_heart_failure_ L2 - http://www.nejm.org/doi/full/10.1056/NEJM199702203360801?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -