FOURIER: Evolocumab reduces risk for CV events in atherosclerotic CVD

Amgen announced that FOURIER, the CV outcomes trial of its PCSK9 inhibitor evolocumab, met its primary endpoint and key secondary endpoint.

Full results will be presented in March at the American College of Cardiology Scientific Session.

FOURIER was a phase 3, double blind, randomized controlled trial of about 27,500 patients with MI, ischemic stroke of symptomatic peripheral artery disease who had LDL 70 mg/dL or non-HDL 100 mg/dL despite optimal statin therapy.

Patients were assigned subcutaneous injections of placebo or evolocumab (Repatha, Amgen) 140 mg every 2 weeks or 420 mg every month. The study was powered for 1,630 major adverse cardiac events, defined as CV death, MI or stroke, according to a press release issued by Amgen.

Amgen stated in the release that the study met its primary endpoint of CV death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina or coronary revascularization; and its key secondary endpoint of CV death, nonfatal MI or nonfatal stroke.

Researchers did not observe any new safety issues during the study, according to the release.

Amgen also announced that in the EBBINGHAUS study of approximately 1,900 patients from FOURIER, also to be presented at the ACC Scientific Session, evolocumab was noninferior to placebo for effect on cognitive function.

“These FOURIER results show unequivocally the connection between lowering LDL with Repatha and [CV] risk reduction, even in a population already treated with optimized statin therapy,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release.

Evolocumab is approved by the FDA for lowering of LDL in patients with atherosclerotic CVD or familial hypercholesterolemia, but not for reduction of CV events.

Disclosure: Harper is an employee of Amgen.