PMID- 29962050
OWN - NLM
STAT- MEDLINE
DCOM- 20181108
LR  - 20210109
IS  - 1932-8737 (Electronic)
IS  - 0160-9289 (Print)
IS  - 0160-9289 (Linking)
VI  - 41
IP  - 9
DP  - 2018 Sep
TI  - Rationale and design of a randomized study to assess the efficacy and safety of 
      evolocumab in patients with diabetes and dyslipidemia: The BERSON clinical trial.
PG  - 1117-1122
LID - 10.1002/clc.23018 [doi]
AB  - Type 2 diabetes mellitus (T2DM) is a major independent risk factor for 
      cardiovascular disease, and diabetic dyslipidemia is a major contributor to 
      cardiovascular risk in these patients. Here we report the rationale and design of 
      a phase 3, double-blind study specifically designed to evaluate the 
      lipid-lowering efficacy of the proprotein convertase subtilisin/kexin type 9 
      (PCSK9) inhibitor evolocumab in patients with T2DM and hyperlipidemia or mixed 
      dyslipidemia who are on background statin therapy. In the BERSON (evolocumaB 
      Efficacy for LDL-C Reduction in subjectS with T2DM On background statiN) trial, 
      patients with T2DM, a screening low-density lipoprotein cholesterol (LDL-C) level 
      of >/= 2.6 mmol/L (>/=100 mg/dL) or >/= 3.4 mmol/L (>/=130 mg/dL), and with or without 
      statin treatment at screening, respectively, were enrolled and started on 
      atorvastatin 20 mg/day for a lipid stabilization period of at least 4 weeks. 
      Then, patients were randomly assigned in a 2:2:1:1 ratio to receive atorvastatin 
      20 mg once daily plus either evolocumab 140 mg every 2 weeks (Q2W), evolocumab 
      420 mg every month (QM), placebo Q2W, or placebo QM. The co-primary outcome 
      measures were the percentage change from baseline in LDL-C at week 12 and the 
      percentage change from baseline in LDL-C at the mean of weeks 10 and 12. The 
      BERSON trial has completed enrollment. The study completed in the first half of 
      2018, and will provide information on the efficacy and safety of evolocumab in 
      patients with T2DM and dyslipidemia.
CI  - (c) 2018 Wiley Periodicals, Inc.
FAU - Lorenzatti, Alberto J
AU  - Lorenzatti AJ
AUID- ORCID: 0000-0003-4180-2010
AD  - Instituto Medico DAMIC/Fundacion Rusculleda, Cordoba, Argentina.
FAU - Eliaschewitz, Freddy G
AU  - Eliaschewitz FG
AD  - Centro de Pesquisas Clinicas, Sao Paulo, Brazil.
FAU - Chen, Yundai
AU  - Chen Y
AUID- ORCID: 0000-0003-4409-9375
AD  - Department of Cardiology, Chinese People Liberation Army General Hospital, 
      Beijing, China.
FAU - Fialkow, Jonathan
AU  - Fialkow J
AD  - Cardiovascular Center of South Florida, Miami, Florida, USA.
FAU - Lu, Juming
AU  - Lu J
AD  - Department of Endocrinology, Chinese People Liberation Army General Hospital, 
      Beijing, China.
FAU - Baass, Alexis
AU  - Baass A
AD  - Department of Medicine, Royal Victoria Hospital, Quebec, Canada.
FAU - Monsalvo, Maria Laura
AU  - Monsalvo ML
AD  - Clinical Development, Amgen Inc., Thousand Oaks, California, USA.
FAU - Hsu, Hui-Chun
AU  - Hsu HC
AD  - Clinical Development, Amgen Inc., Thousand Oaks, California, USA.
FAU - Somaratne, Ransi
AU  - Somaratne R
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
GR  - Amgen Inc./
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180921
PL  - United States
TA  - Clin Cardiol
JT  - Clinical cardiology
JID - 7903272
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Lipids)
RN  - LKC0U3A8NJ (evolocumab)
SB  - IM
MH  - Antibodies, Monoclonal/*administration & dosage
MH  - Antibodies, Monoclonal, Humanized
MH  - Anticholesteremic Agents/administration & dosage
MH  - Diabetes Mellitus, Type 2/blood/complications/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Dyslipidemias/blood/complications/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lipids/*blood
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC6489947
OTO - NOTNLM
OT  - PCSK9
OT  - PCSK9 inhibitor
OT  - diabetes
OT  - diabetic dyslipidemia
OT  - dyslipidemia
OT  - hypercholesterolemia
OT  - monoclonal antibody
COIS- The authors take responsibility for all aspects of the reliability and freedom 
      from bias of the data presented here and their discussed interpretation. Maria 
      Laura Monsalvo, Ransi Somaratne, and Hui-Chun Hsu report that they are employees 
      of Amgen Inc. (or were at the time of the study) and own Amgen stock/stock 
      options. Ransi Somaratne is also an inventor on at least one pending patent 
      application owned by Amgen Inc. relating to evolocumab. Alberto J. Lorenzatti has 
      received research funding and personal fees from Amgen during the study. Freddy 
      G. Eliaschewitz has served as a speaker and has received grants for research from 
      Amgen, Sanofi, Boehringer, Eli Lilly, Novo Nordisk, and AstraZeneca. Yundai Chen, 
      Juming Lu, and Jun-bo Ge have no conflicts of interest to report. Jonathan 
      Fialkow has served on speakers' bureau for Amgen Inc. and Amarin. Alexis Baass is 
      a consultant or scientific advisor for Amgen and Regeneron, receives research 
      grants from Amgen, Regeneron, Merck, and AstraZeneca and participates in clinical 
      trials for Amgen, Pfizer, Ionis, Regeneron, and Sanofi.
EDAT- 2018/07/03 06:00
MHDA- 2018/11/09 06:00
PMCR- 2018/09/21
CRDT- 2018/07/03 06:00
PHST- 2018/03/21 00:00 [received]
PHST- 2018/06/25 00:00 [revised]
PHST- 2018/06/27 00:00 [accepted]
PHST- 2018/07/03 06:00 [pubmed]
PHST- 2018/11/09 06:00 [medline]
PHST- 2018/07/03 06:00 [entrez]
PHST- 2018/09/21 00:00 [pmc-release]
AID - CLC23018 [pii]
AID - 10.1002/clc.23018 [doi]
PST - ppublish
SO  - Clin Cardiol. 2018 Sep;41(9):1117-1122. doi: 10.1002/clc.23018. Epub 2018 Sep 21.