Clinical Data
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 two 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 occured first.