Heart failure & cardiomyopathiesMeta-analysis
Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials
- Pooled participant-level analysis of randomised trials
- post-hoc
- placebo-controlled
- 4 RCTs (SELECT, FLOW, STEP-HFpEF, STEP-HFpEF DM)
Authors' conclusion
In patients with HFpEF, semaglutide reduced the risk of the combined endpoint of cardiovascular death or worsening heart failure events, and worsening heart failure events alone, whereas its effect on cardiovascular death alone was not significant.
Study context
- Population
- Patients with HFpEF (mildly reduced or preserved EF): all STEP-HFpEF trial participants and those with investigator-reported HFpEF history from SELECT and FLOWof 22,282 in 4 RCTs
- Participants
- 3,743 patients
- Comparison
- Semaglutide vs placebo
- Semaglutiden = 1,914
- Placebon = 1,829reference
- Outcome
- CV death or first worsening HF event (hospitalisation or urgent visit for HF); also first worsening HF event and CV death
Pooled result
CV death or worsening HF events
Hazard ratio
0.69
95% CI 0.53–0.89
P = 0.0045
Events by group
Semaglutide vs Placebo
HR 0.69 (95% CI 0.53–0.89); P = 0.0045
As reported in the abstract
Further pooled results
Worsening HF events (hospitalisation or urgent visit for HF)
- Semaglutide reduced worsening HF events: 54 [2.8%] vs 86 [4.7%]
- HR 0.59 [0.41-0.82]; p=0.0019
- main outcome; post-hoc pooled analysis; full analysis set (ITT)
CV death
- No significant effect on CV death alone: 59 [3.1%] vs 67 [3.7%]
- HR 0.82 [0.57-1.16]; p=0.25
- main outcome; post-hoc pooled analysis; full analysis set (ITT)
Safety
Serious adverse events
Original publication
Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. Published 30 August 2024. doi:10.1016/s0140-6736(24)01643-x
Summarised from the published abstract; every number is checked against it