Amgen: Repatha reduces all‑cause mortality in high‑risk primary prevention (VESALIUS‑CV)
- Pre‑specified VESALIUS‑CV analysis of >12,000 high‑risk patients found Repatha reduced risk of death by 20%.
- Mortality benefit appeared after ~1.5 years and persisted through a median follow‑up of 4.6 years.
- Prior VESALIUS‑CV reports showed 25% reduction in 3‑point MACE and 36% reduction in heart attack; median on‑treatment LDL‑C was ~45 mg/dL with Repatha versus 109 mg/dL with placebo.
- Two global real‑world studies found many high‑risk patients undertreated and women less likely than men to receive intensive lipid‑lowering or meet LDL‑C goals.
Primary mortality findings
In a pre‑specified secondary analysis of the Phase 3 VESALIUS‑CV trial (>12,000 adults at high cardiovascular risk without prior myocardial infarction or stroke), evolocumab (Repatha) added to statins and/or other LDL‑lowering therapy reduced the risk of death by 20%. The analysis reports meaningful reductions in both overall and cardiovascular deaths; the mortality separation began at approximately 1.5 years and continued through a median follow‑up of 4.6 years.
Additional event analyses
VESALIUS‑CV analyses showed Repatha reduced first, subsequent and total cardiovascular events, and a reduction in heart attack risk was evident as early as six months after treatment initiation. The heart attack benefit was primarily driven by type‑1 (plaque‑rupture) events and larger infarctions, with consistent effects across key subgroups. Investigators emphasised the value of earlier, intensive LDL‑C lowering to alter patient trajectories.
Trial context and prior results
VESALIUS‑CV randomized patients with LDL‑C ≥90 mg/dL (or equivalent non‑HDL‑C or apoB thresholds) on the highest tolerated statin/ezetimibe dose; median baseline LDL‑C was 122 mg/dL and median on‑treatment LDL‑C in a lipid sub‑study was 45 mg/dL with Repatha versus 109 mg/dL with placebo. Earlier VESALIUS‑CV publication reported a 25% relative reduction in 3‑point MACE, a 19% reduction in a broader 4‑point composite, and a 36% reduction in heart attack.
Real‑world evidence and regulatory notes
Two global real‑world studies presented alongside the trial data identified gaps in lipid management: low initiation, intensification and monitoring rates, and sex disparities with women less likely to receive intensive therapy or meet goals. Regulatory updates cited include a U.S. label expansion in August 2025 and a European Commission expanded indication in August 2026 based on VESALIUS‑CV results.
Source: Amgen
