Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

Amgen has announced that the FOURIER trial evaluating whether Repatha (evolocumab) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). No new safety issues were observed.

The EBBINGHAUS cognitive function trial conducted in FOURIER patients also achieved its primary endpoint, demonstrating that Repatha was non-inferior to placebo for the effect on cognitive function.

"In the GLAGOV study, we demonstrated that Repatha has an effect on atherosclerosis, the underlying cause of cardiovascular disease. These FOURIER results show unequivocally the connection between lowering LDL cholesterol with Repatha and cardiovascular risk reduction, even in a population already treated with optimized statin therapy," said Sean E. Harper, executive vice president of R&D at Amgen. "Cardiovascular disease remains the number one health burden in the world, and we look forward to sharing these outcomes data with the scientific community at the ACC 66th Annual Scientific Session."

FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) is a multinational Phase 3 double-blind, randomized, placebo-controlled trial in approximately 27,500 patients who had either an MI, an ischemic stroke or symptomatic peripheral artery disease and an LDL =70 mg/dL or a non-HDL-C =100 mg/dL on optimized statin therapy. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. Patients were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly or placebo subcutaneous every 2 weeks or monthly. The study continued until at least 1,630 patients experienced a key secondary MACE (major adverse cardiac event) endpoint of cardiovascular death, MI or stroke, whichever occurred first.

EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects) is a double-blind, placebo-controlled randomized non-inferiority trial involving approximately 1,900 patients enrolled in the FOURIER outcomes study. Executive function (Spatial Working Memory strategy index - primary endpoint) and secondary endpoints of working memory, memory function, and psychomotor speed were assessed using a tablet-based tool (CANTAB) at baseline and select time points.