Safety profile of semaglutide versus placebo in the SELECT study: a randomized controlled trial
Authors' conclusion
The long-term safety profile observed in the Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity (SELECT) study is consistent with previously reported semaglutide studies. No new safety concerns were identified for once-weekly semaglutide 2.4 mg.
Study context
- Population
- Patients with established CVD and overweight or obesity
- Comparison
- Once-weekly subcutaneous semaglutide 2.4 mg vs placebo
- Primary endpoint
- Safety: SAEs, all adverse events (AEs) leading to permanent treatment discontinuation, and prespecified AEs of special interest
Primary result
As reported in the abstract
P < 0.001
Safety
SAEs: cardiac disorders
P < 0.001
AEs leading to discontinuation · higher with semaglutide
P < 0.001
AEs leading to discontinuation: gastrointestinal disorders
SAEs leading to discontinuation
Suicide/self-injury SAEs
Gallbladder-related disorders · more frequent with semaglutide
P = 0.04
Cholelithiasis
Cholecystitis
Serious adverse events (SAEs) leading to discontinuation
- Similar between groups
Suicide/self-injury SAEs
- Low and balanced between groups
Cholecystitis
- Similar between groups
Original publication
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