Phase II (OSLER-1) and Phase III (OSLER-2) studies confirm reduction of CV events with Rapatha (evolocumab)-Amgen

Amgen announced one-year data from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase II (OSLER-1) and Phase III (OSLER-2) open-label extension studies of Repatha (evolocumab), a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication. These data were presented at a Late-Breaking Clinical Trial session at the American College of Cardiology's 64th Annual Scientific Session (ACC.15) and published in the New England Journal of Medicine . A two-year analysis of Repatha safety and tolerability data from the longest proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trial to date (OSLER-1) was also presented. Data from prespecified exploratory endpoints in the ongoing open-label OSLER-1 and OSLER-2 studies showed Repatha plus standard of care (SOC) treatment reduced adjudicated cardiovascular events (0.95 percent Repatha plus SOC; 2.18 percent SOC) over a one-year analysis period. Adverse events (AEs) (=1 percent in the Repatha plus SOC group and more frequent in the Repatha plus SOC group by at least 1 percent) included arthralgia, headache, pain in extremity and fatigue. The cardiovascular events analysis comprises exploratory findings from the ongoing open-label OSLER studies. Repatha plus SOC treatment reduced LDL-C by 61 percent compared to SOC.The OSLER-1 and OSLER-2 trials are ongoing open-label extension studies designed to characterize long-term effects of Repatha.

See-"Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events"-Marc S. Sabatine,et al. and the Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators March 15, 2015DOI: 10.1056/NEJMoa1500858.

Comment:During approximately 1 year of therapy, the use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis.