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

on behalf of the REWIND Trial Investigators

Research output: Contribution to journalArticle

66 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)42-49
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

Incretins
Cardiovascular Diseases
Hospitalization
Heart Failure
Glucagon-Like Peptide 1
Unstable Angina
Glycosylated Hemoglobin A
Appetite
Subcutaneous Injections
General Practice
Type 2 Diabetes Mellitus
Blood Glucose
Stroke
Myocardial Infarction
Placebos
Body Weight
Blood Pressure
Kidney
Safety
Injections

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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title = "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",
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.",
author = "{on behalf of the REWIND Trial Investigators} and Gerstein, {Hertzel C.} and Colhoun, {Helen M.} and Dagenais, {Gilles R.} and Rafael Diaz and Mark Lakshmanan and Prem Pais and Jeffrey Probstfield and Riddle, {Matthew C.} and Lars Ryd{\'e}n and Denis Xavier and Atisso, {Charles M.} and Alvaro Avezum and Jan Basile and Namsik Chung and Ignacio Conget and Cushman, {William C.} and Edward Franek and Nicolae Hancu and Markolf Hanefeld and Shaun Holt and Petr Jansky and William Cushman and Fernando Lanas and Leiter, {Lawrence A.} and Patricio Lopez-Jaramillo and Cardona-Munoz, {Ernesto G.} and Valdis Pirags and Nana Pogosova and Raubenheimer, {Peter J.} and Jonathan Shaw and Sheu, {Wayne H.H.} and Theodora Temelkova-Kurktschiev",
year = "2018",
month = "1",
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doi = "10.1111/dom.13028",
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AU - on behalf of the REWIND Trial Investigators

AU - Gerstein, Hertzel C.

AU - Colhoun, Helen M.

AU - Dagenais, Gilles R.

AU - Diaz, Rafael

AU - Lakshmanan, Mark

AU - Pais, Prem

AU - Probstfield, Jeffrey

AU - Riddle, Matthew C.

AU - Rydén, Lars

AU - Xavier, Denis

AU - Atisso, Charles M.

AU - Avezum, Alvaro

AU - Basile, Jan

AU - Chung, Namsik

AU - Conget, Ignacio

AU - Cushman, William C.

AU - Franek, Edward

AU - Hancu, Nicolae

AU - Hanefeld, Markolf

AU - Holt, Shaun

AU - Jansky, Petr

AU - Cushman, William

AU - Lanas, Fernando

AU - Leiter, Lawrence A.

AU - Lopez-Jaramillo, Patricio

AU - Cardona-Munoz, Ernesto G.

AU - Pirags, Valdis

AU - Pogosova, Nana

AU - Raubenheimer, Peter J.

AU - Shaw, Jonathan

AU - Sheu, Wayne H.H.

AU - Temelkova-Kurktschiev, Theodora

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

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U2 - 10.1111/dom.13028

DO - 10.1111/dom.13028

M3 - Article

VL - 20

SP - 42

EP - 49

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 1

ER -