Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes
Primary resultResult — go to the resultHazard ratio 0.74 95% CI 0.58–0.95Authors' conclusion
In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide.
Study context
- Population
- Patients with T2DM on standard care at high CV risk (83.0% with established CVD, CKD or both)
- Participants
- 3,297 patients
- Comparison
- Once-weekly semaglutide vs placebo
- Semaglutiden = 1,648
- Placebon = 1,649reference
- Primary endpoint
- First occurrence of CV death, nonfatal MI or nonfatal stroke
- Follow-up
- 104 weeks
Methodological detailsplacebo-controlled, non-inferiority
- Placebo-controlled
- Non-inferiority
Primary result
As reported in the abstract
Hazard ratio
0.74
95% CI 0.58–0.95
P < 0.001 for noninferiority
Events by treatment group
Semaglutide vs Placebo
HR 0.74 (95% CI 0.58–0.95); P < 0.001 for noninferiority
Further findings
| Outcome | Semaglutide | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Nonfatal MI | 2.9% | 3.9% | 0.74 (0.51–1.08) | P = 0.12 | |
| Nonfatal stroke | 1.6% | 2.7% | 0.61 (0.38–0.99) | P = 0.04 | |
| 0.20.5125Hazard ratio (log scale) |
CV death
- Similar rates in the two groups
New or worsening nephropathy
- Lower rates with semaglutide
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Retinopathy complications (vitreous hemorrhage, blindness, or conditions requiring intravitreal agent or photocoagulation) | 1.76 (1.11–2.78) | P = 0.02 | |
| 0.20.5125Hazard ratio (log scale) |
Serious adverse events; discontinuation due to adverse events
- Fewer serious adverse events with semaglutide
- More discontinuations due to adverse events with semaglutide, mainly gastrointestinal
Original publication
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. Published 15 September 2016. doi:10.
Summarised from the published abstract; every number is checked against it