THOUSAND OAKS – November 06, 2026 -- Amgen reported that Repatha (evolocumab) lowered the risk of fatal or nonfatal heart attack by 20% compared with ezetimibe in adults with atherosclerotic cardiovascular disease (ASCVD) and prior statin use. The real-world study followed 544,103 patients for up to four years and was published in The American Journal of Preventive Cardiology.
Four-year heart attack risk falls to 5.88% with Repatha versus 7.76% with ezetimibe
Among 225,048 patients with a baseline LDL-C measurement, the four-year cumulative risk of heart attack was 5.88% on Repatha and 7.76% on ezetimibe. Among patients without a baseline LDL-C measurement, the corresponding risks were 5.65% and 7.06%.
The primary outcome was fatal or nonfatal myocardial infarction. The hazard ratio was 0.80 (95% CI, 0.70-0.91).
Study compares 64,421 Repatha starters with 479,682 ezetimibe starters
The non-interventional, active-comparator, new-user cohort study drew on de-identified data from the Komodo Healthcare Map. Patients initiated treatment between 2017 and 2024 in routine U.S. clinical care, with follow-up through June 2026.
The analysis applied a target trial framework, which mirrors the design of a randomized clinical trial. Researchers used inverse probability weighting to balance measured baseline characteristics between the two groups. A calibrated estimator accounted for incomplete baseline LDL-C data. A prespecified sensitivity analysis that continued follow-up regardless of changes in background statin therapy produced consistent results.
Data targets a gap in non-statin treatment choices under ACC/AHA guidance
Amgen Chief Medical Officer Paul Burton said the study offers "clear evidence" to help physicians choose between adding Repatha or ezetimibe.
Nihar Desai, associate professor of medicine at Yale University School of Medicine, noted that the recent ACC/AHA Multisociety Guideline update recognizes both ezetimibe and PCSK9 inhibitors as non-statin options for ASCVD patients. He said clinicians had lacked direct cardiovascular outcomes evidence to guide that choice toward the recommended LDL-C goals of <70 mg/dL and <55 mg/dL.
Repatha is approved in 75 countries and used by about 9 million patients
Repatha, a PCSK9-inhibiting monoclonal antibody, was first approved in 2015. The U.S. Food and Drug Administration broadened its approved use in August 2025 to adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL-C. In August 2026, the European Commission approved an expanded indication for adults with established or high risk for ASCVD, based on the Phase 3 VESALIUS-CV trial.
Amgen states that Repatha has been studied in 51 clinical trials involving more than 57,000 patients over 15 years. It is approved in the U.S., Japan, Canada and all 28 countries it counts as European Union members, with applications pending elsewhere.
On access, Amgen reports that about 96% of U.S. patients are covered for Repatha across insurance types, with most paying less than $50 per month. Through its direct-to-patient program AmgenNow, Repatha is available at nearly 60% below the monthly list price.