New Data on Novel Investigational Cholesterol Drug, CV Events
Amgen announced one-year results from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha (evolocumab) for the treatment of high cholesterol at a Late-Breaking Clinical Trial session at the American College of Cardiology's 64th Annual Scientific Session and in a new article published in the New England Journal of Medicine. A two-year analysis of Repatha safety and tolerability data from the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trial (OSLER-1) was also presented. Evolocumab is a human monoclonal antibody that works by blocking PCSK9.
The OSLER-1 and OSLER-2 trials are ongoing open-label extension studies designed to determine long-term effects of Repatha. The trials enrolled 4,465 patients who had completed 1 of 12 Phase 2 and 3 Repatha studies, 2,976 of whom were randomized to subcutaneous Repatha 140mg every two weeks or 420mg monthly plus standard of care (SOC) therapy (usually moderate or high-intensity statin therapy) and 1,489 were randomized to SOC alone over one year.
Compared to SOC alone, Repatha plus SOC reduced cardiovascular events (death, myocardial infarction, unstable angina requiring hospitalization, coronary revascularization, stroke and transient ischemic attack or heart failure requiring hospitalization) compared to SOC alone (0.95% Repatha plus SOC vs. 2.18% SOC over one year), with a consistent effect on death, coronary and cerebrovascular events as well as by subgroups (eg, age, sex, baseline LDL-C, statin use, National Cholesterol Education Program [NCEP] risk). Across each of the major cardiovascular events included in the composite endpoint (death, heart attack, stroke, hospitalization, angioplasty) and in patient subgroups, there was a 53% reduction in cardiovascular events in the evolocumab arm. No differences were observed based on age, baseline LDL levels, statin use, primary or secondary prevention, or history of valve disease. Repatha plus SOC treatment reduced LDL-C by 61% compared to SOC. Patients who received evolocumab were able to achieve an absolute reduction in LDL cholesterol of more than 70mg/dL reaching 48mg/dL on average.
Currently Amgen is investigating evolocumab's effect on cardiovascular outcomes in 27,500 patients. Results are expected to be announced in 2017.
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