Heart failure & cardiomyopathiesSecondary analysis
Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction
- Secondary analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials
- prespecified
- pooled
- placebo-controlled
- sex subgroup analysis
Authors' conclusion
In patients with obesity-related HFpEF, semaglutide 2.4 mg reduced body weight to a greater extent in women, and produced similar improvements in HF-related symptoms, physical limitations, and exercise function, regardless of sex.
Study context
- Population
- Patients with heart failure (HF), LVEF ≥45%, BMI ≥30 kg/m² and KCCQ-CSS <90 points (obesity-related heart failure with preserved ejection fraction (HFpEF))570 (49.7%) women
- Participants
- 1,145 patients
- Comparison
- Semaglutide 2.4 mg once weekly vs placebo, by sex
- Primary endpoint
- Dual primary: KCCQ-CSS change and percentage change in body weight, compared between sexes
- Follow-up
- 52 weeks
Primary result
As reported in the abstract
KCCQ-CSS change and % change in body weight, by sex
Semaglutide vs PlaceboMean difference, % (95% CI)
body weight, women
−9.6(−10.9% to −8.4%)
body weight, men
−7.2(−8.4% to −6.0%)
Mean difference, points
- KCCQ-CSS, women
- +7.6 (95% CI 4.5–10.7)
- KCCQ-CSS, men
- +7.5 (95% CI 4.3–10.6)
Secondary outcomes
6MWD change, by sex
- Semaglutide improved 6MWD in both sexes
- P interaction = 0.21
Hierarchical composite endpoint (all-cause death, HF events, KCCQ-CSS, 6MWD), by sex
- Semaglutide improved the hierarchical composite endpoint in both sexes
- P interaction = 0.66
Original publication
Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. Published 23 June 2024. doi:10.1016/j.jacc.2024.06.001
Summarised from the published abstract; every number is checked against it