KEY POINTS:
- Historically women have been underrepresented in cardiovascular clinical trials, however, rates of Heart Failure with Preserved Ejection Fraction are rising more rapidly in women
- FINEARTS-HF trial enrolled 46% of female participants and demonstrated a reduction in heart failure exacerbations in both sexes with the use of finerenone, compared to placebo
At the American Heart Association Scientific Sessions 2024, Dr Misato Chimura from the University of Glasgow presented a secondary analysis of the FINEARTS-HF Trial featuring a sex-specific analysis, with simultaneous publication in JAMA Cardiology.
Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). Since there was no specific data on the treatment effect of finerenone according to sex, the authors thought to estimate the efficacy and safety of finerenone compared with placebo in both women and men.
The FINEARTS-HF trial demonstrated that finerenone significantly reduced the risk of hospitalization or urgent outpatient visits in patients with HFpEF and HFmrEF. In this multi-center, randomized, double-blind, placebo-controlled trial 6,001 patients were randomized in a 1:1 fashion to receive finerenone, a non-steroidal mineralocorticoid, or placebo. The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).
A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]).
The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P = .41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction). Finerenone had similar tolerability in women and men. This pre specified secondary analysis showed that finererone reduced the risk of primary endpoint similarly in women and men with HFmrEF or HFpEF.