Real‐world safety profile of once‐weekly semaglutide in people with type 2 diabetes: Analysis of pooled data from the SemaglUtide Real‐world Evidence (SURE) programme
Authors' conclusion
Safety data reported in the real-world SURE studies were generally consistent with observations in phase 3 OW semaglutide RCTs. No new safety concerns were identified, highlighting that OW semaglutide is well tolerated by adults with T2D and in subpopulations in routine clinical practice.
Study context
- Population
- Adults with diagnosed T2D treated with once-weekly (OW) semaglutide in routine clinical practice; studies of ≈30 weeks
- Participants
- 3,505 adults9 studies
- Outcome
- Safety, including AEs and hypoglycaemic events
- Follow-up
- ≈30 weeks
Methodological detailsSURE programme, pooled data
- SURE programme
- Pooled data
Pooled result
As reported in the abstract
Safety of OW semaglutide
- Reported adverse events (AEs)
- 24.3%
- Non-serious AEs
- 22.3%
- Mild AEs
- 17.1%
- Gastrointestinal disorders AEs
- 16.3%
- AEs leading to treatment discontinuation
- 5.1%
- Serious adverse drug reactions
- 0.5%
- AE with fatal outcome, reported as unrelated to treatment
- 0.2%
- Level 2 hypoglycaemic events
- 1.1%
- Level 3 hypoglycaemic events
- 0.1%
Further pooled results
- Higher rate of level 2 hypoglycaemia with baseline microvascular complications on insulin vs insulin without these complications
Safety
- AEs leading to treatment discontinuation
- 5.1%
- Serious adverse drug reactions
- 0.5%
- Fatal AE (unrelated to treatment)
- 0.2%
- Level 2 hypoglycaemia
- 1.1%
- Level 3 hypoglycaemia
- 0.1%
Original publication
Real‐world safety profile of once‐weekly semaglutide in people with type 2 diabetes: Analysis of pooled data from the SemaglUtide Real‐world Evidence (SURE) programme. Diabetes Obes Metab. Published 8 August 2024. doi:10.
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