1. Home>
2. Specialties>
3. General Medicine>
4. Summary and Comment

Digoxin for Women: A Note of Caution

Among men, mortality was slightly lower with digoxin than with placebo; however, among women, mortality was slightly higher with digoxin.

In a large, placebo-controlled, randomized trial of digoxin therapy for patients with heart failure (mean ejection fraction, 28%), digoxin reduced the rate of hospitalization for worsening heart failure but did not reduce overall mortality (Journal Watch Feb 28 1997). Now, in a post hoc analysis of data from that trial, researchers have examined whether outcomes were similar in men and women.

During 3 years of follow-up, mortality was slightly lower with digoxin than with placebo among men (35% vs. 37%), but was slightly higher with digoxin than with placebo among women (33% vs. 29%). This interaction between sex and digoxin was statistically significant (P=0.03). Moreover, digoxin therapy was associated with a 9-percentage-point reduction in the rate of hospitalization for heart failure among men, but only a 4-percentage-point reduction among women. Here, the interaction between sex and digoxin was of borderline significance (P=0.05). In multivariable analyses that adjusted for other differences between male and female participants, a sex/digoxin interaction was significant both for mortality and for hospitalization for heart failure.

Comment: According to this analysis, digoxin was beneficial for men, but not for women, with heart failure. The reasons are unclear; nevertheless, the authors believe that their findings should be taken seriously, given known sex-related differences in clinical and physiologic aspects of heart failure. Despite the hazards of post hoc subgroup analyses, clinicians probably should be cautious when they prescribe digoxin for women, at least until experts weigh in on the implications of these new data.

— Allan S. Brett, MD

Published in Journal Watch General Medicine November 15, 2002

Citation(s):

Rathore SS et al. Sex-based differences in the effect of digoxin for the treatment of heart failure. N Engl J Med 2002 Oct 31; 347:1403-11.

• Original article (Subscription may be required)
• Medline abstract (Free)