FOURIER outcomes phase III study of Repatha shows effectiveness in myocardial infarction.- Amgen

Amgen announced a new analysis from the Repatha (evolocumab) cardiovascular outcomes (FOURIER) phase III study that evaluates the effectiveness of Repatha in patients who have suffered a recent myocardial infarction (MI). The analysis showed that patients who experienced a recent MI (less than one year) were at higher risk of subsequent cardiovascular (CV) events compared to patients who had an MI over a year ago. In the analysis, the risk reduction for experiencing a heart attack, stroke or CV death, in Repatha-treated patients treated within one year post MI was 25% compared to 15% in those patients with a more distant MI. In this analysis of the landmark FOURIER outcomes study, 5,711 patients who experienced an MI within one to 12 months of randomization were compared to 16,609 patients with a more distant event (>12 months prior to randomization) to assess the efficacy of Repatha on the primary endpoint (CV death, MI, stroke, unstable angina or coronary revascularization) and the key secondary endpoint (CV death, MI or stroke).

An additional analysis from the FOURIER study presented at AHA reinforces the safety and efficacy of intensive LDL-C lowering with Repatha in high-risk cardiovascular disease (CVD) patients. The analysis evaluated the impact of lowering LDL-C with Repatha on cognition as reported by patients with stable CVD and found that the addition of Repatha to statin therapy had no impact on reported everyday cognition function, including in those with very low LDL-C levels. The results will be presented at the American Heart Association Annual Scientific Sessions in Philadelphia on Monday, Nov. 18.

Comment: FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase III randomized, double-blind, placebo-controlled trial, was designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint was the time to cardiovascular death, myocardial infarction or stroke.