The FINANCIAL -- THOUSAND OAKS, Calif. -- Amgen announced the upcoming presentation of new Repatha (evolocumab) analyses, including a late-breaking study evaluating the efficacy of Repatha in patients with metabolic syndrome and established cardiovascular disease at the ESC Congress 2018, organized by the European Society of Cardiology, in Munich, Aug. 25-29.
Six abstracts, including two analyses from the Repatha cardiovascular outcomes study (FOURIER), will be presented, providing further insight into the efficacy and safety of Repatha among a variety of patient groups. Data on the residual risk and financial burden for patients with atherosclerotic cardiovascular disease (ASCVD) across Europe will also be presented.
A full list of Amgen-sponsored abstracts at ESC Congress 2018 can be found online and below:
Late-Breaking Science Session
FOURIER - Efficacy of PCSK9 inhibition with evolocumab in patients with Metabolic Syndrome
Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. 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. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.