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.

Baker Heart and Diabetes Institute Melbourne Australia

Department of Medicine and Population Health Research Institute McMaster University and Hamilton Health Sciences Hamilton Canada

Department of Medicine Oregon Health and Science University Portland Portland Oregon

Department of Medicine University of Washington Seattle Washington

Dresden Technical University Dresden Germany

ECLA Academic Research Organization and ICR Instituto Cardiovascular de Rosario Rosario Argentina

Eli Lilly and Company Indianapolis Indiana

Endocrinology and Nutrition Department Hospital Clínic i Universitari Barcelona Spain

Hungarian Institute of Cardiology Semmelweis University Budapest Hungary

Instituto Dante Pazzanese de Cardiologia and University Santos Amaro São Paulo Brazil

Iuliu Hatieganu University of Medicine and Pharmacy Cluj Napoca Romania

Karolinska Institute Stockholm Sweden

Keenan Research Centre in the Li Ka Shing Knowledge Institute of St Michael's Hospital University of Toronto Toronto Canada

Latvijas Universitate Riga Latvia

Medical University of South Carolina Charleston South Carolina

Memphis Veterans Affairs Medical Center Memphis Tennessee

Mossakowski Medical Research Centre Polish Academy of Sciences and Central Clinical Hospital MSW Warsaw Poland

National Research Center for Preventive Medicine Moscow Russia

Research Institute FOSCAL and Medical School Universidad d Santander UDES Bucaramanga Colombia

Robert Koch Medical Center Sofia Bulgaria

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

Universite Laval Quebec City Canada

University Hospital Motol Prague Czech Republic

University of Cape Town Cape Town South Africa

University of Edinburgh Edinburgh UK

Victoria University of Wellington Wellington New Zealand

Yonsei University Health System Seoul South Korea

Ann Transl Med. 2017 Dec;5(23):476. doi: 10.21037/atm.2017.10.24. PubMed

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ClinicalTrials.gov
NCT01394952