VESALIUS-CV: Evolocumab Reduces Cardiovascular Events in Patients With High-Risk Diabetes

A new subgroup analysis of the VESALIUS-CV trial has revealed that evolocumab, on top of statins and other LDL-C-lowering therapies, reduces cardiovascular events in patients with high-risk diabetes mellitus.1

These data were presented at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, by Lawrence Leiter, MD, director of the Lipid Clinic, associate director of the Clinical Nutrition and Risk Factor Modification Centre, and associate scientist at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital in Toronto.

“People with diabetes face double the risk of heart attack or stroke compared to those without the condition,” Jay Bradner, MD, executive vice president of research and development in artificial intelligence and data at Amgen, said in a statement. “These VESALIUS-CV results show that early, intensive LDL-C reduction to 45 mg/dL with Repatha is critical to help prevent life-altering cardiovascular events in those with high-risk disease.”2

The VESALIUS-CV study was an international, double-blind, randomized, placebo-controlled trial conducted at 774 sites in 33 countries. It was initially intended to investigate the effects of evolocumab on the risk of major adverse cardiovascular events (MACEs) among patients without a previous myocardial infarction or stroke. The trial’s primary endpoints were a composite of death from coronary heart disease, myocardial infarction, or ischemic stroke (3-point MACE) and a composite of 3-point MACE and ischemia-driven arterial revascularization (4-point MACE).3

Patients were eligible for inclusion if they had LDL-C ≥90 mg/dL, non-HDL-C ≥120 mg/dL, or apoB ≥80 mg/dL. Additionally, patients were required to exhibit ≥1 of the following at screening:

• Significant coronary artery disease
• Significant atherosclerotic cerebrovascular disease
• Significant peripheral arterial disease
• Diabetes mellitus4

A total of 12,257 patients were enrolled in the trial and randomly assigned in a 1:1 ratio to either evolocumab (n = 6129) or placebo (n = 6128). Among these patients, 3-point MACE occurred in 336 in the evolocumab group and 443 in the placebo group. 4-point MACE occurred in 747 patients in the evolocumab group and 907 in the placebo group. The VESALIUS-CV team saw no evidence of between-group differences in safety events during the trial.3

The present analysis found that 6002 patients across both groups had high-risk diabetes mellitus. Of these, median age was 66, 66% were on a high-intensity statin, and 24% were on an SGLT2 inhibitor or a GLP-1 receptor agonist. Additionally, 67% of these patients had no qualifying atherosclerosis. After the 4.6 median years of follow-up in the original trial, evolocumab reduced 3-point MACE by 29% versus placebo in patients with high-risk diabetes and 21% in those without. Evolocumab decreased 4-point MACE by 21% among patients with diabetes and 18% in those without.1

Leiter and colleagues also observed nominally lower mortality in both subgroups. Risk of myocardial infarction was also reduced by 35-36% in both subgroups. These findings were consistent among patients with high-risk diabetes for both endpoints regardless of qualifying atherosclerosis, baseline LDL-C, statin intensity, and use of SGLT2 inhibitors or GLP-1 receptor agonists.1

The team ultimately concluded that evolocumab’s cardioprotective effects extend to patients whose risk stems from high-risk diabetes mellitus, including patients already on alternative cardioprotective agents.1

References

1. Leiter L, Marston N, Gaetano M, et al. Evolocumab Reduces CV Events in Patients with High-Risk Diabetes: Results from the VESALIUS-CV Trial. Abstract presented at the American Diabetes Association (ADA) Scientific Sessions, New Orleans, LA. June 5-8, 2026.

2. Amgen. Amgen Presents New Data Across its Cardiometabolic Portfolio at the American Diabetes Association 86th Scientific Sessions. June 7, 2026. Accessed June 7, 2026. https://www.amgen.com/newsroom/press-releases/2026/06/amgen-presents-new-data-across-its-cardiometabolic-portfolio-at-american-diabetes-association-86th-scientific-sessions

3. Bohula EA, Marston NA, Bhatia AK, et al. Evolocumab in patients without a previous myocardial infarction or stroke. New England Journal of Medicine. 2026;394(2):117-127. doi:10.1056/nejmoa2514428

4. Amgen. Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV). ClinicalTrials.gov Identifier: NCT03872401. Updated November 10, 2025. Accessed June 7, 2026. https://clinicaltrials.gov/study/NCT03872401