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Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial
HC. Gerstein, HM. Colhoun, GR. Dagenais, R. Diaz, M. Lakshmanan, P. Pais, J. Probstfield, JS. Riesmeyer, MC. Riddle, L. Rydén, D. Xavier, CM. Atisso, L. Dyal, S. Hall, P. Rao-Melacini, G. Wong, A. Avezum, J. Basile, N. Chung, I. Conget, WC....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie
NLK
ProQuest Central
od 1992-01-04 do Před 3 měsíci
Nursing & Allied Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health & Medicine (ProQuest)
od 1992-01-04 do Před 3 měsíci
Family Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Psychology Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health Management Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Public Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
- MeSH
- cévní mozková příhoda prevence a kontrola MeSH
- diabetes mellitus 2. typu komplikace farmakoterapie MeSH
- dvojitá slepá metoda MeSH
- glukagonu podobné peptidy analogy a deriváty terapeutické užití MeSH
- hypoglykemika terapeutické užití MeSH
- imunoglobuliny - Fc fragmenty terapeutické užití MeSH
- infarkt myokardu prevence a kontrola MeSH
- kardiovaskulární nemoci mortalita prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- rekombinantní fúzní proteiny terapeutické užití MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
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.
Baker Heart and Diabetes Institute Melbourne VIC Australia
Department of Internal Medicine Dresden Technical University Dresden Germany
Department of Medicine K2 Karolinska Institutet Stockholm Sweden
Department of Medicine Oregon Health and Science University Portland OR USA
Department of Medicine University of Washington Seattle WA USA
ECLA Estudios Clínicos Latinoamérica Rosario Argentina
Eli Lilly and Company Indianapolis IN USA
Endocrinology and Nutrition Department Hospital Clínic i Universitari Barcelona Spain
Institut Universitaire de Cardiologie et Pneumologie Université Laval Québec City QC Canada
Instituto Dante Pazzanese de Cardiologia and University Santo Amaro São Paulo Brazil
Iuliu Hatieganu University of Medicine and Pharmacy Cluj Napoca Romania
Latvijas Universitate Riga Latvia
Li Ka Shing Knowledge Institute St Michael's Hospital University of Toronto Toronto ON Canada
Medical University of South Carolina Charleston SC USA
Memphis Veterans Affairs Medical Center Memphis TN USA
National Medical Research Center of Cardiology Moscow Russia
Research Institute FOSCAL and Medical School Universidad de Santander UDES Bucaramanga Colombia
Robert Koch Medical Centre Sofia Bulgaria
Semmelweis University Hungarian Institute of Cardiology Budapest Hungary
St John's Research Institute Bangalore India
Taichung Veterans General Hospital Taichung Taiwan
Universidad de Guadalajara Centro Universitario de Ciencias de la Salud Guadalajara Mexico
Universidad de La Frontera Temuco Chile
University Hospital Motol Prague Czech Republic
University of Cape Town Cape Town South Africa
University of Edinburgh Edinburgh UK
Citace poskytuje Crossref.org
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- $a Gerstein, Hertzel C $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.
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- $a 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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