Spironolactone therapy was associated with reduced all-cause mortality in women (hazard ratio: 0.66 p = 0.01) but not in men (p interaction = 0.02). There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components. Women were older with fewer comorbidities but worse patient-reported outcomes. Sex differences in outcomes and treatment effects were determined using time-to-event analysis. Secondary outcomes included all-cause mortality, CV, and non-CV mortality and CV, HF, and non-CV hospitalization. The primary outcome was a composite of cardiovascular (CV) death, cardiac arrest, or HF hospitalization. Subjects enrolled from the Americas were analyzed. Subjects with symptomatic HF and a left ventricular ejection fraction ≥45% were randomized to spironolactone or placebo therapy. This was an exploratory, post hoc, non-pre-specified analysis of the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial. Sex differences in responses to effects of mineralocorticoid antagonists have not been reported. HFpEF affects women more frequently than men. This study sought to investigate sex differences in outcomes and responses to spironolactone in patients with heart failure with preserved ejection fraction (HFpEF).
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