Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial
Authors' conclusion
Oral semaglutide reduced major adverse cardiovascular event outcomes independently of concomitant SGLT2i treatment, and this combination appeared to be safe.
Study context
- Population
- T2DM with atherosclerotic CVD and/or CKD, analysed by baseline SGLT2i use (yes n=2596; no n=7054) and any in-trial SGLT2i use (yes n=4718; no n=4932)
- Participants
- 9,650 participants
- Comparison
- Oral semaglutide vs placebo, by SGLT2i use
- Primary endpoint
- Time to first MACE:
- CV death
- Nonfatal MI
- Nonfatal stroke
- Follow-up
- Mean 47.5±10.9 months
Methodological detailsprespecified subgroup analysis, placebo-controlled
- Prespecified subgroup analysis
- Placebo-controlled
Primary result
As reported in the abstract
MACE by baseline SGLT2i use (subgroups)
Oral semaglutide
- SGLT2i at baseline
- 143 of 1296
- No SGLT2i at baseline
- 436 of 3529
Placebo
- SGLT2i at baseline
- 158 of 1300
- No SGLT2i at baseline
- 510 of 3525
SGLT2i at baseline
Oral semaglutide143 of 1296
Placebo158 of 1300
No SGLT2i at baseline
Oral semaglutide436 of 3529
Placebo510 of 3525
Oral semaglutide vs PlaceboHazard ratio (95% CI)
SGLT2i at baseline
0.89(0.71–1.11)
No SGLT2i at baseline
0.84(0.74–0.95)
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| MACE, overall trial population14% lower risk | 0.86 (0.77–0.96) | |
| 0.512Hazard ratio (log scale) |
Safety
Adverse event profile with or without concomitant SGLT2i
- Adverse event profiles of oral semaglutide with or without SGLT2i similar
Original publication
Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial. Circulation. Published 29 March 2025. doi:10.
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