Amgen’s Repatha Cuts First Major CV Events by 31% in High-Risk Diabetics

AMGNAMGN

Amgen’s Repatha cut first major adverse cardiovascular events by 31% in 3,655 high-risk diabetic patients without known atherosclerosis over a median 4.8-year follow-up in the Phase 3 VESALIUS-CV trial. The subgroup achieved a median LDL-C of 44 mg/dL at 96 weeks versus 105 mg/dL with placebo on optimized lipid-lowering therapy.

1. VESALIUS-CV Subgroup Analysis

In a new subgroup analysis of Phase 3 VESALIUS-CV, 3,655 high-risk primary prevention patients with diabetes and no known significant atherosclerosis were followed for a median 4.8 years. Adding Repatha to optimized lipid-lowering therapy reduced the risk of first major adverse cardiovascular events by 31% for both 3-P MACE and 4-P MACE composites.

2. LDL-C Reduction Achieved

Patients receiving Repatha achieved a median LDL-C of 44 mg/dL at 96 weeks compared with 105 mg/dL in the placebo arm. Secondary composite endpoints also showed consistent risk reductions, including 31% fewer heart attacks, 34% fewer ischemia-driven revascularizations and a 33% reduction in ischemic strokes.

3. Expanded Clinical Implications

These findings support earlier, more intensive LDL-C lowering in high-risk primary prevention populations before atherosclerosis advances. Guideline updates may recommend initiating PCSK9 inhibition sooner to help eligible patients reach LDL-C targets below 45 mg/dL and reduce first-event risk.

Sources

F