Heart failure & cardiomyopathiesRandomised controlled trial
Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity
- Randomised controlled trial
- placebo-controlled
Authors' conclusion
In patients with heart failure with preserved ejection fraction and obesity, treatment with semaglutide (2.4 mg) led to larger reductions in symptoms and physical limitations, greater improvements in exercise function, and greater weight loss than placebo.
Study context
- Population
- Patients with HFpEF and BMI ≥30
- Participants
- 529 patients
- Comparison
- Semaglutide 2.4 mg once weekly vs placebo
- Primary endpoint
- Dual: change from baseline in KCCQ-CSS (0–100, higher = fewer symptoms and physical limitations) and change in body weight
- Follow-up
- 52 weeks
Primary result
As reported in the abstract
Semaglutide
16.6 points
Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) mean change · Body weight mean % change −13.3%
Placebo
8.7 points
KCCQ-CSS mean change · Body weight mean % change −2.6%
Semaglutide vs PlaceboEstimated difference, points (95% CI)P value
KCCQ-CSS
7.8(4.8–10.9)
P < 0.001Semaglutide vs PlaceboEstimated difference, percentage points (95% CI)P value
body weight
−10.7(−11.9 to −9.4)
P < 0.001Secondary outcomes
Mean change, m
| Outcome | Semaglutide | Placebo | estimated difference (m) (95% CI) | P value | |
|---|---|---|---|---|---|
| 6-minute walk distance (confirmatory secondary) | 21.5 | 1.2 | 20.3 (8.6–32.1) | P < 0.001 | |
| −2002040Difference, m (linear scale) |
| Outcome | win ratio (95% CI) | P value | |
|---|---|---|---|
| Hierarchical composite (death, HF events, KCCQ-CSS and 6-minute walk distance change) | 1.72 (1.37–2.15) | P < 0.001 | |
| 0.512Win ratio (log scale) |
Mean percentage change
| Outcome | Semaglutide | Placebo | estimated treatment ratio (95% CI) | P value |
|---|---|---|---|---|
| CRP level | −43.5% | −7.3% | 0.61 (0.51–0.72) | P < 0.001 |
Safety
Serious adverse events
Original publication
Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. Published 25 August 2023. doi:10.1056/nejmoa2306963
Summarised from the published abstract; every number is checked against it