Amgen has reported new Phase 3 findings showing that Repatha (evolocumab) reduced the risk of death among adults at high cardiovascular risk who had not previously experienced a heart attack or stroke.
The findings come from a pre-specified analysis of the VESALIUS-CV trial involving more than 12,000 patients. According to the company, adding Repatha to statins or other LDL-C-lowering treatments was associated with a 20% reduction in the risk of death compared with placebo.
“For people at high risk of a heart attack or stroke, lowering LDL-C or ‘bad’ cholesterol with Repatha may do more than help prevent these events; it may also reduce the risk of dying from heart disease and its serious consequences,” said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. “This is especially significant given cardiovascular disease remains the leading cause of death worldwide. The totality of these data is practice-changing and reinforces the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha.”
The mortality benefit became apparent after about 1.5 years of treatment and continued during the study’s median follow-up of 4.6 years. Researchers reported reductions in both overall and cardiovascular deaths.
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“These analyses reinforce that a patient’s first major cardiovascular event is not merely an isolated occurrence, but often a transition to a higher risk state,” said Marc S. Sabatine, M.D., M.P.H., Chair of the TIMI Study Group and the Lewis Dexter, MD, Endowed Chair in Cardiovascular Medicine at Mass General Brigham Heart & Vascular Institute. “Evolocumab reduced not only first cardiovascular events, but also subsequent events during the course of the study, the latter of which almost doubled the number of events prevented. By preventing these events, evolocumab can alter the patient’s trajectory, with lower rates of all-cause mortality and consistent effects for both cardiovascular and non-cardiovascular mortality. Together, these data support the large clinical benefit of intensive LDL-C lowering with evolocumab down to ~40 mg/dL to help prevent cardiovascular morbidity and mortality.”
Additional analyses found that Repatha reduced first, subsequent and total cardiovascular events, while another analysis indicated that the reduction in heart attack risk could be observed as early as six months after treatment began. The results were presented at the 2026 European Society of Cardiology Congress in Munich and published in Circulation.
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Separate real-world analyses also highlighted gaps in cholesterol management, with many high-risk patients failing to receive intensive treatment or reach recommended LDL-C targets.
