Research Shows Evolocumab Helps Reduce CV Events in High Risk Patients

March 28, 2026 — Amgen announced today that 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 ACC.26 in New Orleans. 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 optimized lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimized lipid-lowering therapy arm (548 patients in the subgroup were part of a lipid sub-study).

"The evidence is unequivocal: Intensive LDL-C lowering with Repatha significantly reduces the risk of major CV events for high-risk patients," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "The new ACC/AHA Multisociety Guideline on the Management of Dyslipidemia reinforces the importance of earlier, more intensive lowering of LDL-C to prevent CV events. VESALIUS-CV builds on this, showing that in high-risk patients without prior heart attack or stroke, lowering LDL-C beyond what is typically achieved today can meaningfully reduce risk before ASCVD takes hold. These data also show the benefit of lowering LDL-C below 45 mg/dL with Repatha, a level that may not be achieved with statins or ezetimibe alone. Now is the time to treat earlier and help all appropriate patients reach lower LDL-C goals."

Across secondary endpoints, Repatha demonstrated consistent benefit, including the following composite endpoints: heart attack, ischemic stroke or any ischemia-driven revascularization; CHD death, heart attack or revascularization; 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 revascularization 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).

"This analysis clearly demonstrates that the CV benefit of evolocumab in the VESALIUS-CV study includes those who had no known ASCVD, or significant plaque buildup in the arteries," said Nicholas Marston, M.D., M.P.H., assistant professor of medicine, member of the TIMI Study Group and cardiologist at Brigham and Women's Hospital and Harvard Medical School. "Lowering LDL-C earlier with more intensive therapy in high-risk primary prevention patients, before plaque becomes advanced, can prevent the clinical onset of heart disease. These findings confirm the substantial risk reduction that can be achieved by treating more proactively with evolocumab rather than waiting for the development of significant atherosclerosis or a CV event to then intensify lipid-lowering therapy."

For more information please visit www.Repatha.com and Amgen.com

Repatha was first approved in 2015. In August 2025, the U.S. 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.