Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials
Authors' conclusion
In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction.
Study context
- Population
- Adults with HF with LVEF ≥45%, BMI ≥30 kg/m², NYHA II–IV and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points, with or without T2DM
- Participants
- 1,145 adults
- Comparison
- Semaglutide 2.4 mg once weekly vs placebo for 52 weeks
- Semaglutiden = 573
- Placebon = 572reference
- Outcome
- Dual: change in KCCQ-CSS and change in bodyweight
- Follow-up
- Baseline to week 52
Methodological detailsindividual patient data, double-blind, placebo-controlled, 129 sites in 18 countries
- Individual patient data
- Double-blind
- Placebo-controlled
- 129 sites in 18 countries
Pooled result
As reported in the abstract
week 52
Semaglutide vs PlaceboMean between-group difference, points (95% CI)P value
KCCQ-CSS change
7.5(5.3–9.8)
P < 0.0001Semaglutide vs PlaceboMean between-group difference, % (95% CI)P value
Bodyweight
−8.4(−9.2 to −7.5)
P < 0.0001Further pooled results
| Outcome | Mean between-group difference (metres) (CI) | P value | |
|---|---|---|---|
| 6-min walk distance · week 52 | 17.1 (9.2–25.0) | P < 0.0001 | |
| −100102030Difference, metres (linear scale) |
| Outcome | Win ratio (CI) | P value | |
|---|---|---|---|
| Hierarchical composite (all-cause death, HF events, KCCQ-CSS and 6-min walk distance changes) | 1.65 (1.42–1.91) | P < 0.0001 | |
| 0.512Win ratio (log scale) |
| Outcome | Treatment ratio (CI) | P value | |
|---|---|---|---|
| CRP concentrations | 0.64 (0.56–0.72) | P < 0.0001 | |
| 0.512Treatment ratio (log scale) |
Dual primary endpoints across subgroups (age, race, sex, BMI, SBP, baseline C-reactive protein (CRP), LVEF)
- Efficacy largely consistent across subgroups
Safety
Events
| Outcome | Semaglutide | Placebo |
|---|---|---|
| Serious adverse events | 161 | 301 |
- Serious adverse events: safety in all who received ≥1 dose
Original publication
Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials. Lancet. Published 7 April 2024. doi:10.
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