Amgen announced on November 5, 2026, results from a large real-world study showing that evolocumab (Repatha) reduced the risk of fatal or nonfatal heart attacks by 20% compared with ezetimibe in people with atherosclerotic cardiovascular disease (ASCVD) and prior statin use.¹ The study followed more than 544,000 adults for up to 4 years and was published in the American Journal of Preventive Cardiology.¹,²
Key facts
- Drug: evolocumab (Repatha; Amgen)
- Class: PCSK9 inhibitor monoclonal antibody
- Study: real-world, active-comparator, new-user cohort (Komodo Healthcare Map)
- Population: 544,103 adults with ASCVD and prior statin use
- Groups: 64,421 evolocumab; 479,682 ezetimibe (2017-2024)
- Primary outcome: fatal or nonfatal MI over up to 4 years
- Result: 20% lower MI risk (HR, 0.80; 95% CI, 0.70-0.91)
- Publication: American Journal of Preventive Cardiology
"These findings provide important comparative data that can help clinicians distinguish between these treatment options and make more informed choices to reduce their patients' cardiovascular risk," said Nihar Desai, MD, MPH, associate professor of medicine and vice chief of the Section of Cardiovascular Medicine at Yale University School of Medicine, in a company press release.¹
What did the study find?
Treatment with evolocumab lowered the rate of fatal or nonfatal myocardial infarction (MI) compared with ezetimibe (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.70-0.91).¹,² Among the 225,048 patients with a baseline low-density lipoprotein cholesterol (LDL-C) measurement, the 4-year cumulative risk of heart attack was 5.88% with evolocumab vs 7.76% with ezetimibe.¹
How was the study designed?
The non-interventional, active-comparator, new-user cohort study applied a target trial framework intended to mirror a randomized clinical trial, comparing adults with ASCVD and prior statin use who initiated evolocumab or ezetimibe in routine US clinical care.² It drew on de-identified data from the Komodo Healthcare Map database, including 64,421 adults who initiated evolocumab and 479,682 who initiated ezetimibe between 2017 and 2024, with follow-up through June 2026.² The primary outcome was fatal or nonfatal MI over up to 4 years.²
To account for differences between the groups, the researchers used inverse probability weighting to balance measured baseline characteristics and a calibrated estimator to address incomplete baseline LDL-C data.² A prespecified sensitivity analysis that continued follow-up regardless of changes in background statin therapy produced consistent results.²