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Diabetes Obes Metab. 2019 Mar 1. doi: 10.1111/dom.13680. [Epub ahead of print]

Randomised Study of Evolocumab in Patients With Type 2 Diabetes and Dyslipidaemia on Background Statin: Primary Results of the BERSON Clinical Trial.

Author information

1
Instituto Medico DAMIC / Fundación Rusculleda, Córdoba, Argentina.
2
CPCLIN - Centro de Pesquisas Clínicas, Rua Goias, São Paulo, Brazil.
3
Department of Cardiology, Chinese People Liberation Army General Hospital, Beijing, China.
4
Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.
5
Department of Medicine, Royal Victoria Hospital, Montreal, Québec, Canada.
6
Clinical Development, Amgen Inc, Thousand Oaks, California, USA.
7
Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.

Abstract

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/day and were randomised 2:2:1:1 to evolocumab 140mg every 2 weeks (Q2W) or 420mg monthly (QM) or placebo Q2W or QM. Co-primary endpoints were the percentage change in 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 cholesterol (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-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C, and VLDL-C 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 parameters (fasting serum glucose and haemoglobin A1c ) 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. This article is protected by copyright. All rights reserved.

KEYWORDS:

dyslipidaemia; evolocumab; hyperlipidaemia; phase 3; type 2 diabetes

PMID:
30821053
DOI:
10.1111/dom.13680

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