Overview
- The VESALIUS‑CV subgroup, presented Saturday at the ACC meeting and published in JAMA, found evolocumab reduced the first major cardiovascular event to 5.0% vs 7.1% over about five years.
- The PCSK9 inhibitor drove LDL cholesterol down to a median 52 mg/dL at 48 weeks and about 44 mg/dL at 96 weeks vs roughly 111 and 105 mg/dL on placebo, with low levels maintained to five years.
- Investigators reported similar rates of serious adverse events between groups, and editorialists noted that long‑term safety for sustained PCSK9 inhibition remains uncertain.
- The analysis covered 3,655 patients with diabetes and no known significant atherosclerosis, though not all had coronary imaging and the cohort was older and predominantly White, which limits broad generalization.
- Experts said the results support lowering LDL targets earlier in high‑risk diabetes and could influence guidelines and coverage decisions, with cost and insurer approval now key hurdles for wider use.