Evolocumab in Patients With High-Risk Diabetes: Results From the VESALIUS-CV Trial
Authors' conclusion
Evolocumab reduced the rate of cardiovascular events in patients with high-risk diabetes, regardless of the presence or absence of qualifying atherosclerosis and background use of other cardioprotective agents.
Study context
- Population
- Patients with high-risk diabetes (microvascular disease, insulin use, or duration ≥10 years) or qualifying atherosclerosis, no prior myocardial infarction (MI) or stroke, LDL-C ≥90 mg/dL; 67% on high-intensity statin, 24% on SGLT2i or GLP-1 RA at baseline
- Participants
- 6,002 high-risk diabetes
- Comparison
- Evolocumab 140 mg vs placebo every 2 weeks
- Primary endpoint
- Dual primary end points: 3P-MACE (coronary heart disease death, MI or ischemic stroke) and 4P-MACE (3P-MACE plus ischemia-driven arterial revascularization)
- Follow-up
- Median 4.6 years
Methodological detailsplacebo-controlled
- Placebo-controlled
Primary result
As reported in the abstract
Evolocumab vs PlaceboEstimate (95% CI)P value
Relative rate decreased by 29%
HR (3P-MACE) 0.71(0.59–0.86)
P = 0.0004Relative rate decreased by 21%
HR (4P-MACE) 0.79(0.69–0.91)
P = 0.0013Further findings
LDL-C · 48 weeks
P < 0.0001
| Outcome | Evolocumab | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| All-cause death | 8.8% | 11.0% | 0.79 (0.67–0.93) | |
| 0.512Hazard ratio (log scale) |
Subgroups: qualifying atherosclerosis, baseline LDL-C, statin intensity, SGLT2i or GLP-1 RA use
- Findings consistent across subgroups
- Pint > 0.05 for each
Original publication
Evolocumab in Patients With High-Risk Diabetes: Results From the VESALIUS-CV Trial. Diabetes Care. Published 7 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →