Amgen announced new detailed findings from its Phase 3 VESALIUS-CV clinical trial, revealing that Repatha (evolocumab) achieved statistically significant and clinically meaningful reductions in major adverse cardiovascular events (MACE) among high-risk adults with no previous history of heart attack or stroke. When used alongside statins or other low-density lipoprotein cholesterol (LDL-C)–lowering treatments, Repatha became the first and only PCSK9 inhibitor to show a measurable reduction in cardiovascular events in both high-risk primary and secondary prevention.
The large-scale study involved over 12,000 individuals with atherosclerosis or diabetes but without a prior heart attack or stroke. Findings showed that Repatha achieved a 25% relative reduction in the combined risk of coronary heart disease (CHD) death, heart attack, or ischemic stroke (3-P MACE). It also demonstrated a 19% reduction in a broader composite including ischemia-driven arterial revascularization (4-P MACE), and a 36% reduction in heart attack risk. In a lipid sub-study group, patients receiving Repatha achieved a median LDL-C level of 45 mg/dL, compared with 109 mg/dL for those on placebo.
Repatha significantly reduced most secondary endpoints, including composite measures of heart attack, ischemic stroke, or any ischemia-driven revascularization; CHD death, heart attack, or revascularization; and cardiovascular death, heart attack, or ischemic stroke. Numerical trends indicated lower mortality in the Repatha group, including 21% relative risk reduction in cardiovascular death, 11% in CHD death, 20% in all-cause death, and 21% in ischemic stroke.
The study also found meaningful reductions in cardiovascular risk among nearly 60% of participants who had diabetes, underscoring the critical importance of LDL-C management for this group.
No new safety signals emerged during the VESALIUS-CV clinical trial, and Repatha’s tolerability remained consistent with existing U.S. prescribing information. Only treatment-emergent adverse events that were serious or led to discontinuation were recorded.
Cardiovascular disease continues to be the leading cause of death worldwide, with a heart attack or stroke occurring every 40 seconds in the U.S. and three-quarters of these being first-time events. High LDL-C remains one of the most modifiable contributors to such incidents. Approved in 2015, Repatha has been used by more than 6.7 million patients globally.
