Heart failure & cardiomyopathies

Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials

J Am Coll CardiolPublished Secondary analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials

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
Methodological detailsprespecified, pooled, placebo-controlled, sex subgroup analysis
  • Prespecified
  • Pooled
  • Placebo-controlled
  • Sex subgroup analysis

Primary result

As reported in the abstract

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: STEP-HFpEF Trials. J Am Coll Cardiol. Published 23 June 2024. doi:10.1016/j.jacc.2024.06.001

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