The aim of this study was to evaluate the safety and efficacy of long-term Evolocumab, an inhibitor of PCSK9 added to standard therapy versus standard therapy alone. Patients of five works in phase two and seven works in phase three were invited to participate in the extended program. These patients were randomized 2:1 to Evolocumab (n = 2976) versus standard therapy (n = 1489). The Evolocumab was openly administered by subcutaneous injection of 140 mg every 2 weeks or 420 mg once a month. 70% of the population was receiving a statin and 27% receiving high doses.
The primary end point of death, myocardial infarction, unstable angina, coronary revascularization, stroke, transient ischemic attack and re-hospitalization for heart failure was reduced a year with Evolocumab (0.95% versus 2.18%; p = 0.003). The secondary end points such as decreased LDL cholesterol and increased HDL were also better with Evolocumab.
Conclusion
The Evolocumab reduces LDL compared with standard therapy with a significant reduction in cardiovascular events combined to one year. Other jobs with other inhibitors of PCSK9 are under randomization.
Marc Steven Sabatine
2015-03-17
Original title: Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events. The Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators.
