1. OSLER
Trial design: Patients from five phase 2 trials and seven phase 3 trials with evolocumab were invited to participate in the OSLER extension program, and randomized in a 2:1 fashion to either evolocumab or standard of care. They were followed for 6 months.
Results
(p = 0.003)
Primary composite outcome for evolocumab vs. placebo: 0.95% vs. 2.18%, p = 0.003
Absolute reduction in LDL-C over 48 weeks in evolocumab vs. placebo: 73 mg/dl, p < 0.001
1-year all-cause mortality: 0.14% vs. 0.41%, p = 0.33; coronary events: 0.75% vs. 1.3%, p > 0.05 %
Conclusions
Evolocumab significantly reduces LDL-C compared with standard of care, with a significant reduction in composite CV events at 1 year in a mixed group of patients with hyperlipidemia
Dedicated outcomes trials with PCSK9 inhibitors are ongoing
Primary endpoint
Evolocumab
(n = 2,976)
Placebo
(n = 1,489)
Sabatine MS, et al. N Engl J Med 2015;Mar 15:[Epub]