Effects of Evolocumab on Cardiovascular Events.

BACKGROUND:

Evolocumab is a potent lipid-lowering drug that decreases plasma levels of lowdensity lipoprotein cholesterol (LDL-C) by 50-60%. FOURIER is a landmark randomized trial involving 27,564 patients with established cardiovascular disease already on statins and plasma LDLC levels > 70 mg/dl.

OBJECTIVE:

The main objective of FOURIER was to examine the effects of evolocumab on cardiovascular events.

RESULTS:

After a mean follow-up of 2.2 years, evolocumab significantly decreased the primary endpoint (composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) by 15% compared to placebo [hazard ratio 0.85 (95% CI, 0.79-0.92)], but no significant effect was found on mortality. The most common adverse effect of evolocumab was mild injection site reaction occurring in 2.1% of patients versus 1.6% of patients receiving placebo.

CONCLUSION:

These results support the use of evolocumab as add-on therapy to statins for high cardiac- risk patients not achieving optimal goals of LDL-C. Longer-term studies are needed to further clarify the efficacy and safety of evolocumab.