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Design and baseline characteristics of participants in the <scp>R</scp> esearching cardiovascular <scp>E</scp> vents with a <scp>W</scp> eekly <scp>IN</scp> cretin in <scp>D</scp> iabetes ( <scp>REWIND</scp> ) trial on the cardiovascular effects of dulaglutide

Authors :
Helen M. Colhoun
Theodora Temelkova-Kurktschiev
Fernando Lanas
Wayne Huey-Herng Sheu
Shaun Holt
Charles Atisso
Matthew C. Riddle
Hertzel C. Gerstein
Nicolae Hancu
Jeffrey L. Probstfield
Valdis Pirags
Petr Jansky
Lawrence A. Leiter
Peter J Raubenheimer
Gilles R. Dagenais
Namsik Chung
Matyas Keltai
Jan Basile
Rafael Diaz
William C. Cushman
Patricio Lopez-Jaramillo
Edward Franek
Lars Rydén
Jonathan E. Shaw
Nana Pogosova
Denis Xavier
Alvaro Avezum
Ignacio Conget
Markolf Hanefeld
Ernesto Germán Cardona-Muñoz
Mark Lakshmanan
Prem Pais
Source :
Diabetes, Obesity and Metabolism. 20:42-49
Publication Year :
2017
Publisher :
Wiley, 2017.

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&#39;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.

Details

ISSN :
14631326 and 14628902
Volume :
20
Database :
OpenAIRE
Journal :
Diabetes, Obesity and Metabolism
Accession number :
edsair.doi...........df9d1994a56a1058cb2e2759e49a1b26
Full Text :
https://doi.org/10.1111/dom.13028