Digoxin increased risk of death in women, but not men, with heart failure
QUESTION: Does the effect of digoxin therapy differ in men and women with heart failure (HF) and depressed left ventricular systolic function?
Design
Randomised {allocation concealed}*, blinded ({participants, healthcare providers,}† and data collectors), placebo controlled trial with up to 48 months of follow up.
Setting
302 clinical centres in the US and Canada.
Patients
5281 men (median age 64 y, 87% white, 30% New York Heart Association [NYHA] class ≥III) and 1519 women (median age 66 y, 81% white, 40.6% NYHA class ≥III) who had clinically confirmed HF (ie, current or past clinical symptoms or signs or radiographic evidence of pulmonary congestion) and an ejection fraction ≤45%. {Follow up was 99%.}*
Intervention
2642 men and 755 women were allocated to digoxin, and 2639 men and 764 …
