PMID- 30851062
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  - Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia 
      on background statin: Pre-specified analysis of the Chinese population from the 
      BERSON clinical trial.
PG  - 1464-1473
LID - 10.1111/dom.13700 [doi]
AB  - AIM: The aim of this study was to evaluate the efficacy and safety of evolocumab 
      with background atorvastatin in Chinese patients with type 2 diabetes mellitus 
      (T2DM) and hyperlipidaemia or mixed dyslipidaemia. MATERIALS AND METHODS: This is 
      a pre-specified analysis of patients in the BERSON study (ClinicalTrials.gov, 
      NCT02662569) in China. Patients initiated background atorvastatin 20 mg/d, after 
      which they were randomized 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 
      420 mg monthly (QM) or to placebo Q2W or QM. Co-primary endpoints were percentage 
      change in LDL 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: Among 453 patients 
      randomized in China, 451 received at least one dose of study drug (evolocumab or 
      placebo). Evolocumab significantly reduced LDL-C compared with placebo at week 12 
      (Q2W, -85.0%; QM, -74.8%) and at the mean of weeks 10 and 12 (Q2W, -80.4%; QM, 
      -81.0%) (adjusted P < 0.0001 for all) when administered with background 
      atorvastatin. Non-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C 
      and VLDL-C significantly improved with evolocumab vs placebo. No new safety 
      findings were observed with evolocumab. The incidence of diabetes AEs was higher 
      with evolocumab compared with placebo. There were no differences over time 
      between evolocumab and placebo in measures of glycaemic control. CONCLUSIONS: In 
      patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving 
      background atorvastatin, 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 - Chen, Yundai
AU  - Chen Y
AD  - Department of Cardiology, Chinese People's Liberation Army General Hospital, 
      Beijing, China.
FAU - Yuan, Zuyi
AU  - Yuan Z
AD  - First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi, China.
FAU - Lu, Juming
AU  - Lu J
AD  - Department of Endocrinology, Chinese People's Liberation Army General Hospital, 
      Beijing, China.
FAU - Eliaschewitz, Freddy G
AU  - Eliaschewitz FG
AD  - CPCLIN/DASA - Centro de Pesquisas Clinicas, Sao Paulo, Brazil.
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 - Monsalvo, Maria Laura
AU  - Monsalvo ML
AD  - Clinical Development, Amgen Inc., Thousand Oaks, California.
FAU - Wang, Nan
AU  - Wang N
AD  - Clinical Development, Amgen Inc., Thousand Oaks, California.
FAU - Hamer, Andrew W
AU  - Hamer AW
AD  - Clinical Development, Amgen Inc., Thousand Oaks, California.
FAU - Ge, Junbo
AU  - Ge J
AD  - Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, 
      Zhongshan Hospital, Fudan University, Shanghai, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02662569
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190414
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - LKC0U3A8NJ (evolocumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - *Antibodies, Monoclonal, Humanized/adverse effects/therapeutic use
MH  - *Anticholesteremic Agents/adverse effects/therapeutic use
MH  - China
MH  - Diabetes Mellitus, Type 2/*complications
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - *Dyslipidemias/complications/drug therapy
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
MH  - Male
MH  - Middle Aged
PMC - PMC6594089
OTO - NOTNLM
OT  - dyslipidaemia
OT  - evolocumab
OT  - hyperlipidaemia
OT  - phase 3
OT  - type 2 diabetes
COIS- 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. 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. M. L. M., N. W. and A. 
      W. H. are employed by and own stock in Amgen Inc. Y. C., Z. Y., J. L. and J. G. 
      have no conflicts of interest to disclose.
EDAT- 2019/03/10 06:00
MHDA- 2020/05/30 06:00
PMCR- 2019/06/26
CRDT- 2019/03/10 06:00
PHST- 2018/12/04 00:00 [received]
PHST- 2019/02/28 00:00 [revised]
PHST- 2019/03/06 00:00 [accepted]
PHST- 2019/03/10 06:00 [pubmed]
PHST- 2020/05/30 06:00 [medline]
PHST- 2019/03/10 06:00 [entrez]
PHST- 2019/06/26 00:00 [pmc-release]
AID - DOM13700 [pii]
AID - 10.1111/dom.13700 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2019 Jun;21(6):1464-1473. doi: 10.1111/dom.13700. Epub 2019 
      Apr 14.