Heart failure & cardiomyopathies

Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial

JAMA CardiolPublished Secondary analysis of the FINEARTS-HF randomised trial

Authors' conclusion

In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men.

Study context

Population
Adults aged ≥40 years with symptomatic heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40%, women and men2,732 women (45.5%)
Participants
6,001 adults
Comparison
Finerenone vs placebo, by sex
Primary endpoint
CV death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits)
Methodological detailsprespecified analysis, phase 3, 653 sites in 37 countries
  • Prespecified analysis
  • Phase 3
  • 653 sites in 37 countries

Primary result

As reported in the abstract

Primary outcome by sex
Finerenone vs PlaceboRate ratio (95% CI)
Women
0.78(0.65–0.95)
Men
0.88(0.74–1.04)

Further findings

Primary outcome incidence rate by sex (per 100 person-years)
per 100 person-years
Women
15.7 (95% CI 14.3–17.3) per 100 person-years
Men
16.8 (95% CI 15.4–18.3) per 100 person-years

Components of primary outcome and all-cause mortality

Consistent effects by sex

Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) change · baseline to 12 months

Greater improvement with finerenone regardless of sex
  • Interaction P = .73

Safety

Similar tolerability in women and men

Original publication

Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol. Published 1 January 2025. doi:10.1001/jamacardio.2024.4613

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