Evolocumab and PROFICIO Project: Initial Results

Czech version

Authors: Pavel Kraml
Authors‘ workplace: II. interní klinika 3. LF UK a FN Královské Vinohrady Praha, přednosta prof. MUDr. Michal Anděl, CSc.
Published in: Vnitř Lék 2015; 61(11): 953-957
Category: Reviews

Overview

The PROFICIO project includes 20 clinical studies evaluating the effect of evolocumab on the incidence of cardiovascular 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.

Key words:
evolocumab – PROFICIO project – LDL-cholesterol – cardiovascular risk

Sources

1. ESC/EAS Guidelines for the management of dyslipidemias. European Heart Journal 2011; 32(14): 1769–1818.

2. Stroes E, Robinson J, Raal F et al. Clinical equivalence of evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 Studies. European Society of Cardiology 29.8.-2.9. 2015. London. Abstract P1756, Poster Presentation.

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Labels

Diabetology Endocrinology Internal medicine

Atherosclerosis: from etiology to its possible influencing

Practical approach to statin intolerance

Early diagnosis of familial hypercholesterolemia in Czech Republic in pursuance of MedPed Project

PCSK9 inhibition as the new hope for patients with familial hypercholesterolemia, statin intolerance and eventually for those at the highest cardiovascular risk? Focused on alirocumab, Praluent®

Position of lipoprotein apheresis in present

The effect of a simvastatin and ezetimib combination on blood lipids and cardiovascular events in diabetic patients (comments on the subanalysis results within the IMPROVE-IT study)

What is the contribution of the review of the evidence on reducing macrovascular risk in patients with atherogenic dyslipidemia? Report on consensus of experts in the importance of the combined therapy by fenofibrate with statin

The TECOS, EXAMINE and SAVOR studies – how do they differ and what are their outcomes?

Clinical importance of basal insulin analogues and insulin Toujeo® 300 units/ml

Article was published in

Internal Medicine

2015 Issue 11