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The effect of gender on outcome in digitalis-treated heart failure patients

M Domanski1, J Fleg, M Bristow

  • 1Clinical Trials Group, National Heart, Lung, and Blood Institute, Bethesda, MD 20892, USA.

Journal of Cardiac Failure
|February 26, 2005
PubMed

Insights

Digitalis treatment for heart failure showed no survival difference between men and women in the SOLVD trials. Further research is needed to explore gender-specific effects in other heart failure populations.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Pharmacology

Background:

  • Digitalis is a recommended treatment for heart failure to reduce hospitalizations.
  • Previous data suggested potential adverse survival effects of digitalis in women, but not men.
  • The Studies of Left Ventricular Dysfunction (SOLVD) investigated gender-based survival differences in digitalis-treated patients.

Purpose of the Study:

  • To determine if there is a gender-based difference in survival among patients with left ventricular dysfunction treated with digitalis.
  • To analyze the association of digitalis with mortality outcomes in women compared to men.

Main Methods:

  • Analysis of symptomatic (n=2569) and asymptomatic (n=4228) patients with ejection fraction <= 0.35 from the SOLVD trials.
  • Assessment of digitalis use at baseline and comparison of demographic variables.
  • Multivariate analysis incorporating risk covariates to examine digitalis's association with all-cause mortality, cardiovascular death, heart failure death, and arrhythmic death, with or without worsening heart failure, comparing women and men.
  • Analysis for interaction between digitalis and gender on mortality.

Main Results:

  • No significant interaction between gender and digitalis treatment on survival was found.
  • Hazard ratios for all-cause mortality, cardiovascular mortality, heart failure mortality, or arrhythmic death with worsening heart failure did not differ significantly between men and women on digitalis.
  • Propensity analysis revealed women fared better than men regarding arrhythmic death without worsening heart failure when adjusted for digitalis treatment probability.

Conclusions:

  • Digitalis treatment for heart failure does not appear to cause a difference in survival between men and women based on SOLVD trial data.
  • A definitive randomized trial is unlikely, necessitating examination of other heart failure populations for a gender-digitalis interaction.
  • Further research into gender-specific responses to digitalis in heart failure is indicated.
Abstract

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