Repatha® (evolocumab), when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments, reduced the risk of first major adverse cardiovascular (CV) events (MACE) in high-risk primary prevention patients without known significant atherosclerosis (buildup of plaque in the arteries) and with diabetes.
The findings were presented in a late-breaking session at the American College of Cardiology (ACC) 75th Annual Scientific Session and simultaneously published in the Journal of the American Medical Association.
The results are from a new subgroup analysis of 3,655 patients at increased risk of CV events without known significant atherosclerosis (all of whom had diabetes) followed for a median of 4.8 years from the phase 3 Vesalius-CV clinical trial.
Results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease (CHD) death, myocardial infarction or ischemic stroke (3‑P MACE) by 31% compared with placebo.
Repatha also reduced the risk of a dual composite primary endpoint that included ischemia‑driven revascularization (4‑P MACE) by 31%.
The median achieved LDL-C was 44 mg/dL at 96 weeks in the Repatha added to optimised lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimised lipid-lowering therapy arm (548 patients in the subgroup were part of a lipid sub-study).
Across secondary endpoints, Repatha demonstrated consistent benefit, including the following composite endpoints: heart attack, ischemic stroke or any ischemia-driven revascularisation; CHD death, heart attack or revascularisation; CV death, heart attack or ischemic stroke. Among individual secondary endpoints, Repatha showed numerical reductions in the risk of heart attack by 31%, ischemia-driven revascularisation by 34% and ischemic stroke by 33%.
Repatha demonstrated numerical trends for reduced mortality rates, including CV death (32% relative risk reduction), CHD death (27% relative risk reduction) and all‑cause death (24% relative risk reduction).
Cardiovascular disease (CVD) is the leading cause of death worldwide, and most CV events occur in people without a prior history of heart attack or stroke. High LDL-C is one of the most modifiable risk factors for heart attack and stroke, and prolonged exposure to elevated LDL‑C increases CV risk over time, making earlier and more intensive LDL‑C lowering critical to reducing the risk of a first CV event.
Repatha was first approved in 2015 and has since been used by more than eight million patients globally. August 2025, the US Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C.
