Repatha Cuts Cardiovascular Events by 29% in High-Risk Diabetes Subgroup

Amgen has reported new Phase 3 VESALIUS-CV subgroup data showing that Repatha® (evolocumab) reduced the risk of major cardiovascular events by 29% in people with long-standing or high-risk diabetes and elevated LDL cholesterol, without a prior history of myocardial infarction or stroke. The findings were presented at the American Diabetes Association (ADA) 86th Scientific Sessions.

The analysis included 6,002 patients with diabetes characterized by microvascular complications, insulin use, or disease duration of at least 10 years. When added to statins or other LDL-lowering therapies, Repatha reduced the composite endpoint of coronary heart disease death, myocardial infarction, or ischemic stroke (3-point MACE) by 29% compared with placebo.

A broader composite endpoint that included ischemia-driven revascularization (4-point MACE) was reduced by 21%.

LDL-C Lowering and Consistency Across Therapies

Repatha is a PCSK9 inhibitor that lowers LDL cholesterol by increasing the liver’s ability to remove circulating LDL particles from the bloodstream.

In a lipid substudy, median LDL-C fell to 45 mg/dL with Repatha compared with 106 mg/dL in the placebo arm. Cardiovascular benefits remained consistent regardless of concurrent treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists, supporting intensive LDL-C reduction as an important component of cardiovascular risk management in diabetes.

Trial Context and Broader Outcomes

These findings build on the broader VESALIUS-CV study (NCT03872401), which enrolled more than 12,000 adults with established atherosclerotic cardiovascular disease or high-risk diabetes, elevated LDL-C, and no prior history of myocardial infarction or stroke.

Previously reported results showed that Repatha reduced 3-point MACE by 25%, 4-point MACE by 19%, and myocardial infarction risk by 36% during a median follow-up of approximately 4.6 years.

Strategic Clinical Perspective

Jay Bradner, M.D., Executive Vice President of Research and Development at Amgen, said the findings reinforce the importance of aggressive LDL-C lowering in people with diabetes, a population that faces substantially higher cardiovascular risk despite contemporary preventive therapies. He noted that achieving deeper LDL-C reductions may help prevent life-altering cardiovascular events before they occur.

Real-World Treatment Challenges

Separately, Amgen presented real-world analyses evaluating GLP-1 therapies in diabetes and obesity. While these agents delivered meaningful improvements in glycemic control and body weight, many patients discontinued treatment within the first year, potentially limiting long-term benefits.

The findings highlight persistent challenges in chronic cardiometabolic disease management and underscore the need for strategies that improve treatment adherence and long-term outcomes.

Global Regulatory Path

Repatha received an expanded U.S. indication in 2025 for adults at increased risk of major cardiovascular events due to uncontrolled LDL-C. The therapy is currently approved in 74 countries worldwide, reflecting its growing role in cardiovascular prevention and long-term lipid management.

Reference

AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS | Amgen Inc.