Abstract
The PROFICIO project includes 20 clinical studies evaluating the effect of evolocumab on the incidence of cardio-vascular disease including its safety profile and tolerance. Most of the included studies follow the average proportional decrease of LDL-cholesterol concentrations over 10 and 12 weeks of administering evolocumab as compared to the input values.
The first results were announced at the congress of the European Society of Cardiology (ESC) in London at the end of August and beginning of September 2015. This subanalysis comprised 3146 patients, who underwent one of the selected studies of phase 3 clinical testing and who were administered a dose of 140 mg s.c. evolocumab once in 2 weeks, or 420 mg s.c. once in 4 weeks.
LDL-cholesterol levels decreased after evolocumab by 56.5 - 74.9% in the individual studies as compared to placebo and by 36.9 - 44.9% compared to ezetimib. The incidence of adverse effects did not differ from the group which used placebo.