Cholesterol-reducer evolocumab associated with a nonsignificant increase in cardiovascular mortality (FOURIER)

Clinical Question

In patients at high risk of cardiovascular death, does the addition of evolocumab to statin therapy decrease cardiovascular-related mortality?

Bottom line

A little sleight of hand here, perhaps unintended (perhaps not): Published data on the effectiveness of evolocumab to prevent mortality may not have represented the actual data in the clinical study report. When causes of death were re-adjudicated by a masked panel, cardiovascular deaths were numerically higher in the evolocumab group, though not to a level that reached statistical significance. 1b-

Study design: Meta-analysis (randomized controlled trials)

Funding: Foundation

Setting: Various (meta-analysis)


Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA

Discuss this POEM


Arup Kumar Dhara

Impact assessment

Very good