PMID- 30821053 OWN - NLM STAT- MEDLINE DCOM- 20200529 LR - 20210109 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 21 IP - 6 DP - 2019 Jun TI - Randomised study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Primary results of the BERSON clinical trial. PG - 1455-1463 LID - 10.1111/dom.13680 [doi] AB - 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 /=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. CI - (c) 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - Lorenzatti, Alberto J AU - Lorenzatti AJ AUID- ORCID: 0000-0003-4180-2010 AD - Clinical Research and Cardiology, Instituto Medico DAMIC / Fundacion Rusculleda, Cordoba, Argentina. FAU - Eliaschewitz, Freddy G AU - Eliaschewitz FG AD - CPCLIN - Centro de Pesquisas Clinicas, Rua Goias, Sao Paulo, Brazil. FAU - Chen, Yundai AU - Chen Y AD - Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing, China. FAU - Lu, Juming AU - Lu J AD - Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China. FAU - Baass, Alexis AU - Baass A AD - Department of Medicine, Royal Victoria Hospital, Montreal, Quebec, Canada. FAU - Monsalvo, Maria Laura AU - Monsalvo ML AD - Clinical Development, Amgen Inc., Thousand Oaks, California, USA. FAU - Wang, Nan AU - Wang N AD - Clinical Development, Amgen Inc., Thousand Oaks, California, USA. FAU - Hamer, Andrew W AU - Hamer AW AD - Clinical Development, Amgen Inc., Thousand Oaks, California, USA. FAU - Ge, Junbo AU - Ge J AD - Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190402 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Anticholesteremic Agents) RN - 0 (Blood Glucose) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 97C5T2UQ7J (Cholesterol) RN - LKC0U3A8NJ (evolocumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/adverse effects/pharmacology/*therapeutic use MH - Anticholesteremic Agents/adverse effects/pharmacology/*therapeutic use MH - Blood Glucose/drug effects MH - Cholesterol/blood MH - Diabetes Mellitus, Type 2/*complications MH - *Dyslipidemias/complications/drug therapy MH - Female MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use MH - Male MH - Middle Aged PMC - PMC6594020 OTO - NOTNLM OT - dyslipidaemia OT - evolocumab OT - hyperlipidaemia OT - phase 3 OT - type 2 diabetes COIS- A.J.L. has served as an advisory board and steering committee member for and has received research grants and speaker fees from Amgen Inc. F.G.E. has served as a speaker for and has received grants for research from Amgen Inc., Sanofi, Boehringer, Eli Lilly, Novo Nordisk, and AstraZeneca. M.L.M., N.W., and A.W.H. are employees of and own stock in Amgen Inc. Y.C., J.L., A.B., and J.G. have no conflicts of interest to disclose. AUTHOR CONTRIBUTIONS: A.J.L. acquired and interpreted the data. F.G.E. acquired the data. Y.C. acquired the data. J.L. acquired the data. A.B. acquired the data. M.L.M. acquired and interpreted the data. N.W. acquired and interpreted the data. A.W.H. acquired and interpreted the data. J.G. acquired the data. All authors are responsible for the work described in this paper. All authors either drafted the manuscript or critically reviewed the manuscript for important intellectual content. All authors gave final approval of the version to be published and agree to be accountable for all aspects of the work insuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. EDAT- 2019/03/02 06:00 MHDA- 2020/05/30 06:00 PMCR- 2019/06/26 CRDT- 2019/03/02 06:00 PHST- 2018/12/04 00:00 [received] PHST- 2019/02/18 00:00 [revised] PHST- 2019/02/28 00:00 [accepted] PHST- 2019/03/02 06:00 [pubmed] PHST- 2020/05/30 06:00 [medline] PHST- 2019/03/02 06:00 [entrez] PHST- 2019/06/26 00:00 [pmc-release] AID - DOM13680 [pii] AID - 10.1111/dom.13680 [doi] PST - ppublish SO - Diabetes Obes Metab. 2019 Jun;21(6):1455-1463. doi: 10.1111/dom.13680. Epub 2019 Apr 2.