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Diabetes Obes Metab. 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. Epub 2017 Jul 14.

Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide.

Author information

1
Department of Medicine and Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
2
University of Edinburgh, Edinburgh, UK.
3
Universite Laval, Quebec City, Canada.
4
ECLA Academic Research Organization and ICR Instituto Cardiovascular de Rosario, Rosario, Argentina.
5
Eli Lilly and Company, Indianapolis, Indiana.
6
St. John's Research Institute, Bangalore, India.
7
Department of Medicine, University of Washington, Seattle, Washington.
8
Department of Medicine, Oregon Health & Science University Portland, Portland, Oregon.
9
Karolinska Institute, Stockholm, Sweden.
10
Instituto Dante Pazzanese de Cardiologia and University Santos Amaro, São Paulo, Brazil.
11
Medical University of South Carolina, Charleston, South Carolina.
12
Yonsei University Health System, Seoul, South Korea.
13
Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.
14
Memphis Veterans Affairs Medical Center, Memphis, Tennessee.
15
Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSW, Warsaw, Poland.
16
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.
17
Dresden Technical University, Dresden, Germany.
18
Victoria University of Wellington, Wellington, New Zealand.
19
University Hospital Motol, Prague, Czech Republic.
20
Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary.
21
Universidad de La Frontera, Temuco, Chile.
22
Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Canada.
23
Research Institute, FOSCAL and Medical School, Universidad d Santander UDES, Bucaramanga, Colombia.
24
Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.
25
Latvijas Universitate, Riga, Latvia.
26
National Research Center for Preventive Medicine, Moscow, Russia.
27
University of Cape Town, Cape Town, South Africa.
28
Baker Heart and Diabetes Institute, Melbourne, Australia.
29
Taichung Veterans General Hospital, Taichung, Taiwan.
30
Robert Koch Medical Center, Sofia, Bulgaria.

Abstract

The aim was to determine the effects of dulaglutide, a synthetic once-weekly, injectable human glucagon-like peptide 1 analogue that lowers blood glucose, body weight, appetite and blood pressure, on cardiovascular outcomes. People with type 2 diabetes, aged ≥50 years, with glycated haemoglobin (HbA1c) ≤9.5%, and either a previous cardiovascular event, evidence of cardiovascular disease or ≥2 cardiovascular risk factors were randomly allocated to a weekly subcutaneous injection of either dulaglutide (1.5 mg) or placebo and followed within the ongoing Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6 months. The primary cardiovascular outcome is the first occurrence of the composite of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke. Secondary outcomes include each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. Follow-up will continue until the accrual of 1200 confirmed primary outcomes. Recruitment of 9901 participants (mean age 66 years, 46% women) occurred in 370 sites located in 24 countries over a period of 2 years. The mean duration of diabetes was 10 years, mean baseline HbA1c was 7.3%, and 31% had prior cardiovascular disease. The REWIND trial's international scope, high proportion of women, high proportion of people without prior cardiovascular disease and inclusion of participants whose mean baseline HbA1c was 7.3% suggests that its cardiovascular and safety findings will be directly relevant to the typical middle-aged patient seen in general practice throughout the world.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01394952.

KEYWORDS:

GLP-1 receptor agonist; antidiabetic drug; cardiovascular disease; clinical trial; diabetes complications

PMID:
28573765
DOI:
10.1111/dom.13028
[Indexed for MEDLINE]

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