Amgen: Repatha (evolocumab) cuts first major CV events 29% in high‑risk diabetes subgroup

VESALIUS‑CV subgroup findings

In an analysis of 6,002 patients with high‑risk diabetes (microvascular disease, insulin use or diabetes duration ≥10 years) and elevated LDL‑C but no prior heart attack or stroke, adding evolocumab (Repatha) to statin or other LDL‑lowering therapy reduced the three‑point MACE composite (CHD death, myocardial infarction or ischemic stroke) by 29% versus placebo and reduced a four‑point composite (including ischemia‑driven revascularization) by 21%.

The median achieved LDL‑C in the Repatha arm was 45 mg/dL versus 106 mg/dL with placebo; 898 subgroup patients contributed to a lipid sub‑study. Approximately one‑third and one‑fifth of patients used SGLT2 inhibitors or GLP‑1 receptor agonists, respectively, at some point, and the observed Repatha benefit was consistent regardless of those therapies.

Real‑world evidence on GLP‑1 therapies

Amgen presented multiple real‑world analyses showing GLP‑1 treatments yield meaningful HbA1c and weight improvements only with sustained use. Across studies, persistence and adherence in routine practice were low, with many patients discontinuing within the first year, which may restrict achievement of guideline‑recommended glycaemic and weight targets compared with clinical trials.

Trial context and publication

VESALIUS‑CV is a Phase 3, double‑blind, randomized, placebo‑controlled global trial of LDL‑C lowering in adults at high cardiovascular risk without prior myocardial infarction or stroke; it enrolled more than 12,000 patients, had a median baseline LDL‑C of 122 mg/dL and a median follow‑up of ~4.6 years. Primary VESALIUS‑CV results were published in the New England Journal of Medicine and subgroup data were published in Diabetes Care.