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Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial

 Hertzel C Gerstein  ;  Helen M Colhoun  ;  Gilles R Dagenais  ;  Rafael Diaz  ;  Mark Lakshmanan  ;  Prem Pais  ;  Jeffrey Probstfield  ;  Jeffrey S Riesmeyer  ;  Matthew C Riddle  ;  Lars Rydén  ;  Denis Xavier  ;  Charles Messan Atisso  ;  Leanne Dyal  ;  tephanie Hall  ;  Purnima Rao-Melacini  ;  Gloria Wong  ;  Alvaro Avezum  ;  Jan Basile  ;  Namsik Chung  ;  Ignacio Conget  ;  William C Cushman  ;  Edward Franek  ;  Nicolae Hancu  ;  Markolf Hanefeld  ;  Shaun Holt  ;  Petr Jansky  ;  Matyas Keltai  ;  Fernando Lanas  ;  Lawrence A Leiter  ;  Patricio Lopez-Jaramillo  ;  Ernesto German Cardona Munoz  ;  Valdis Pirags  ;  Nana Pogosova  ;  Peter J Raubenheimer  ;  Jonathan E Shaw  ;  Wayne H-H Sheu  ;  Theodora Temelkova-Kurktschiev  ;  for the REWIND Investigators 
 LANCET, Vol.394(10193) : 121-130, 2019 
Journal Title
Issue Date
Aged ; Cardiovascular Diseases/mortality ; Cardiovascular Diseases/prevention & control* ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy* ; Double-Blind Method ; Female ; Glucagon-Like Peptides/analogs & derivatives* ; Glucagon-Like Peptides/therapeutic use ; Humans ; Hypoglycemic Agents/therapeutic use* ; Immunoglobulin Fc Fragments/therapeutic use* ; Male ; Middle Aged ; Myocardial Infarction/prevention & control ; Recombinant Fusion Proteins/therapeutic use* ; Stroke/prevention & control
BACKGROUND: Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. METHODS: This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001). INTERPRETATION: Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors. FUNDING: Eli Lilly and Company.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
Chung, Nam Sik(정남식)
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