- VESALIUS‑CV subgroup of 3,655 high‑risk diabetics without known significant atherosclerosis was followed for a median 4.8 years.
- Evolocumab (a PCSK9 inhibitor) added to statin/other LDL‑lowering therapy reduced first major adverse CV events (3‑P MACE) by 31% versus placebo.
- Median LDL‑C achieved was 44 mg/dL at 96 weeks with evolocumab versus 105 mg/dL with placebo; the subgroup lipid sub‑study included 548 patients.
- VESALIUS‑CV Phase 3 enrolled >12,000 patients overall and the full trial reported a 25% reduction in 3‑P MACE and a 36% reduction in heart attack risk.
Trial and population
VESALIUS‑CV is a phase 3, double‑blind randomized placebo‑controlled trial of evolocumab added to optimized lipid‑lowering therapy in adults at high cardiovascular risk without prior MI or stroke; a predefined subgroup of 3,655 patients with diabetes and no known significant atherosclerosis was followed for a median 4.8 years.
Efficacy results
In this subgroup, evolocumab reduced first major adverse cardiovascular events (3‑P MACE: CHD death, MI, ischemic stroke) by 31% versus placebo and reduced the 4‑P MACE (adding ischemia‑driven revascularization) by 31%; secondary analyses showed numerical reductions for MI (31%), ischemia‑driven revascularization (34%) and ischemic stroke (33%), with trends toward lower CV death (32% RRR), CHD death (27% RRR) and all‑cause death (24% RRR).
LDL‑C lowering
Median achieved LDL‑C at 96 weeks was 44 mg/dL with evolocumab versus 105 mg/dL with placebo; 548 patients in the subgroup were included in a lipid sub‑study.
Context and publications
VESALIUS‑CV enrolled more than 12,000 patients overall and previously reported a 25% reduction in 3‑P MACE and a 36% reduction in MI; these subgroup findings were presented at ACC and published in JAMA, and the FDA broadened Repatha's indication in August 2025 to include adults at increased CV risk due to uncontrolled LDL‑C.
