Randomised study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Primary results of the BERSON clinical trial.

Autor: Lorenzatti AJ; Clinical Research and Cardiology, Instituto Medico DAMIC / Fundación Rusculleda, Córdoba, Argentina., Eliaschewitz FG; CPCLIN - Centro de Pesquisas Clínicas, Rua Goias, São Paulo, Brazil., Chen Y; Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing, China., Lu J; Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China., Baass A; Department of Medicine, Royal Victoria Hospital, Montreal, Québec, Canada., Monsalvo ML; Clinical Development, Amgen Inc., Thousand Oaks, California, USA., Wang N; Clinical Development, Amgen Inc., Thousand Oaks, California, USA., Hamer AW; Clinical Development, Amgen Inc., Thousand Oaks, California, USA., Ge J; Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2019 Jun; Vol. 21 (6), pp. 1455-1463. Date of Electronic Publication: 2019 Apr 02.
DOI: 10.1111/dom.13680
Abstrakt: Aim: To evaluate the lipid-lowering efficacy and safety of evolocumab combined with background atorvastatin in patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia.
Materials and Methods: BERSON was a double-blind, 12-week, phase 3 study (NCT02662569) conducted in 10 countries. Patients ≥18 to ≤80 years with type T2DM received atorvastatin 20 mg/d and were randomised 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or placebo Q2W or QM. Co-primary endpoints were the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures, and adverse events (AEs).
Results: Overall, 981 patients were randomised and received ≥1 dose of study drug. Evolocumab significantly reduced LDL-C versus placebo at week 12 (Q2W, -71.8%; QM, -74.9%) and at the mean of weeks 10 and 12 (Q2W, -70.3%; QM, -70.0%; adjusted P < 0.0001 for all) when administered with atorvastatin. Non-high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol improved significantly with evolocumab versus placebo. The overall incidence of AEs was similar between evolocumab and placebo-treated patients, and there were no clinically meaningful differences in changes over time in glycaemic variables (fasting serum glucose and HbA1c) between the two groups.
Conclusions: In patients with T2DM and hyperlipidaemia or mixed dyslipidaemia on statin, evolocumab significantly reduced LDL-C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures.
(© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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