Repatha reduces major cardiovascular events in diabetes subgroup, Amgen reports

A subgroup analysis from the Phase 3 VESALIUS-CV trial reported that adding Repatha to optimized LDL‑lowering therapy reduced first major adverse cardiovascular events by 31% in high-risk primary prevention patients with diabetes; median follow-up was 4.8 years.

Amgen announced new subgroup results from the Phase 3 VESALIUS-CV trial. The findings were presented in a late‑breaking session at the American College of Cardiology and published in the Journal of the American Medical Association. The analysis examined patients at increased risk of cardiovascular events who had diabetes but no known significant atherosclerosis. Patients were followed for a median of 4.8 years and compared Repatha added to statins or other LDL‑lowering therapy against placebo plus optimized therapy. Key findings: - Population: 3,655 high‑risk primary prevention patients with diabetes and no known significant atherosclerosis. - Follow-up: median 4.8 years in the subgroup analysis. - Primary composite endpoint: Repatha added to optimized LDL‑lowering therapy reduced the risk of coronary heart disease death, myocardial infarction or ischemic stroke by 31% versus placebo. - Dual composite endpoint (including ischemia‑driven revascularization): also reduced by 31% versus placebo. - LDL‑C: median achieved 44 mg/dL at 96 weeks with Repatha versus 105 mg/dL with placebo. Summary: The reported results indicate a lower rate of first major adverse cardiovascular events and substantially lower LDL‑C levels in this diabetes subgroup. The findings were presented at a major cardiology meeting and published in a peer‑reviewed journal. How these data will influence clinical practice or regulatory decisions is undetermined at this time.