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

Hertzel C Gerstein, Helen M. Colhoun, Gilles R Dagenais, Rafael Diaz, Mark Lakshmanan, Prem Pais, Jeffrey Probstfield, Matthew C. Riddle, Lars Rydén, Denis Xavier, Charles M. Atisso, Alvaro Avezum, Jan Basile, Namsik Chung, Ignacio Conget, William C. Cushman, Edward Franek, Nicolae Hancu, Markolf Hanefeld, Shaun Holt & 12 others Petr Jansky, Matyas Keltai, Fernando Lanas, Lawrence A Leiter, Patricio Lopez-Jaramillo, Ernesto G. Cardona-Munoz, Valdis Pirags, Nana Pogosova, Peter J. Raubenheimer, Jonathan Shaw, Wayne H.H. Sheu, Theodora Temelkova-Kurktschiev

Research output: Contribution to journalArticleOtherpeer-review

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 ≥50years, 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 (1.5mg) or placebo and followed within the ongoing Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6months. 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 66years, 46% women) occurred in 370 sites located in 24 countries over a period of 2years. The mean duration of diabetes was 10years, 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
Pages (from-to)42-49
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number1
DOIs
Publication statusPublished - Jan 2018
Externally publishedYes

Keywords

  • GLP-1 receptor agonist
  • Antidiabetic drug
  • Cardiovascular disease
  • Clinical trial
  • Diabetes complications

Cite this

Gerstein, Hertzel C ; Colhoun, Helen M. ; Dagenais, Gilles R ; Diaz, Rafael ; Lakshmanan, Mark ; Pais, Prem ; Probstfield, Jeffrey ; Riddle, Matthew C. ; Rydén, Lars ; Xavier, Denis ; Atisso, Charles M. ; Avezum, Alvaro ; Basile, Jan ; Chung, Namsik ; Conget, Ignacio ; Cushman, William C. ; Franek, Edward ; Hancu, Nicolae ; Hanefeld, Markolf ; Holt, Shaun ; Jansky, Petr ; Keltai, Matyas ; Lanas, Fernando ; Leiter, Lawrence A ; Lopez-Jaramillo, Patricio ; Cardona-Munoz, Ernesto G. ; Pirags, Valdis ; Pogosova, Nana ; Raubenheimer, Peter J. ; Shaw, Jonathan ; Sheu, Wayne H.H. ; Temelkova-Kurktschiev, Theodora. / 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. In: Diabetes, Obesity and Metabolism. 2018 ; Vol. 20, No. 1. pp. 42-49.
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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 ≥50years, 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 (1.5mg) or placebo and followed within the ongoing Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6months. 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 66years, 46{\%} women) occurred in 370 sites located in 24 countries over a period of 2years. The mean duration of diabetes was 10years, 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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Gerstein, HC, Colhoun, HM, Dagenais, GR, Diaz, R, Lakshmanan, M, Pais, P, Probstfield, J, Riddle, MC, Rydén, L, Xavier, D, Atisso, CM, Avezum, A, Basile, J, Chung, N, Conget, I, Cushman, WC, Franek, E, Hancu, N, Hanefeld, M, Holt, S, Jansky, P, Keltai, M, Lanas, F, Leiter, LA, Lopez-Jaramillo, P, Cardona-Munoz, EG, Pirags, V, Pogosova, N, Raubenheimer, PJ, Shaw, J, Sheu, WHH & Temelkova-Kurktschiev, T 2018, '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' Diabetes, Obesity and Metabolism, vol. 20, no. 1, pp. 42-49. https://doi.org/10.1111/dom.13028

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. / Gerstein, Hertzel C; Colhoun, Helen M.; Dagenais, Gilles R; Diaz, Rafael; Lakshmanan, Mark; Pais, Prem; Probstfield, Jeffrey; Riddle, Matthew C.; Rydén, Lars; Xavier, Denis; Atisso, Charles M.; Avezum, Alvaro; Basile, Jan; Chung, Namsik; Conget, Ignacio; Cushman, William C.; Franek, Edward; Hancu, Nicolae; Hanefeld, Markolf; Holt, Shaun; Jansky, Petr; Keltai, Matyas; Lanas, Fernando; Leiter, Lawrence A; Lopez-Jaramillo, Patricio; Cardona-Munoz, Ernesto G.; Pirags, Valdis; Pogosova, Nana; Raubenheimer, Peter J.; Shaw, Jonathan; Sheu, Wayne H.H.; Temelkova-Kurktschiev, Theodora.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 1, 01.2018, p. 42-49.

Research output: Contribution to journalArticleOtherpeer-review

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T1 - 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

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 - Keltai, Matyas

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

Y1 - 2018/1

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KW - Antidiabetic drug

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