Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
Primary resultResult — go to the resultHazard ratio 0.86 95% CI 0.77–0.96Authors' conclusion
Among persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, the use of oral semaglutide was associated with a significantly lower risk of major adverse cardiovascular events than placebo, without an increase in the incidence of serious adverse events.
Study context
- Population
- Persons ≥50 years with T2DM (glycated hemoglobin 6.5 to 10.0%) and atherosclerotic CVD, CKD, or bothmedian follow-up 49.5 months
- Participants
- 9,650 persons
- Comparison
- Oral semaglutide vs placebo, in addition to standard care
- Oral semaglutiden = 4,825
- Placebon = 4,825reference
- Primary endpoint
- MACE:
- CV death
- Nonfatal MI
- Nonfatal stroke
Methodological detailsdouble-blind, placebo-controlled, event-driven, superiority
- Double-blind
- Placebo-controlled
- Event-driven
- Superiority
Primary result
As reported in the abstract
Hazard ratio
0.86
95% CI 0.77–0.96
P = 0.006
Events by treatment group
Oral semaglutidevs Placebo
HR 0.86 (95% CI 0.77–0.96); P = 0.006
Secondary outcomes
Confirmatory secondary outcomes (incl. major kidney disease events)
- Did not differ significantly between the two groups
Safety
Serious adverse events
Gastrointestinal disorders
Original publication
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. Published 29 March 2025. doi:10.
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