Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis
Open accessAbstract
Background: The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years. These findings were based on a time-to-first-event analysis and preclude relevant information on the burden of total major events occurring during the trial. This analysis reports on the total cardiovascular or fatal events in the REWIND participants Methods: We compared the total incidence of MACE or non-cardiovascular deaths, and the total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization) or non-cardiovascular deaths between participants randomized to dulaglutide and those randomized to placebo. Incidences were expressed as number per 1000 person-years. Hazard ratios (HR) were calculated using the conditional time gap and proportional means models. Results: Participants had a mean age of 66.2 years, 46.3% were women and 31% had previous cardiovascular disease. During the trial there were 1972 MACE or non-cardiovascular deaths and 3673 expanded MACE or non-cardiovascular deaths. The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82–0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80–0.98) p = 0.022]. The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87–0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82–0.99) p = 0.028]. Conclusions: These findings suggest that weekly subcutaneous dulaglutide reduced total cardiovascular or fatal event burden in people with type 2 diabetes at moderate cardiovascular risk. Clinical Trial Registration:https://www.clinicaltrials.gouv. Unique Identifier NCT01394952).
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Studies have reported beneficial effects in cardiovascular outcomes in populations with type 2 diabetes.
“While studies have reported beneficial effects in cardiovascular outcomes in populations with T2D,19–23 data to understand the long-term health benefits, such as CVD risk reduction, in patients with obesity are limited.24,25”
From Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: <i>post-hoc</i> analysis of the SURMOUNT-5 trial (2025) · cites this paper as [19]
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- Authors
- Dagenais, G. R., Rydén, L., Leiter, L. A., Lakshmanan, M., Dyal, L., Probstfield, J. L., Atisso, C. M., Shaw, J. E., Conget, I., Cushman, W. C., Lopez-Jaramillo, P., Lanas, F., Munoz, E. G. C., Pirags, V., Pogosova, N., Basile, J., Sheu, W. H. H., Temelkova-Kurktschiev, T., Raubenheimer, P. J., Keltai, M., Hall, S., Pais, P., Colhoun, H. M., Riddle, M. C., & Gerstein, H. C.
- Affiliations
- Institut universitaire de cardiologie et de pneumologie de Québec (CA)
- Karolinska Institutet (SE)
- St. Michael's Hospital (CA)
- Eli Lilly (United States) (US)
- Population Health Research Institute (CA)
- University of Washington (US)
- Baker Heart and Diabetes Institute (AU)
- Hospital Clínic de Barcelona (ES)
- University of Tennessee Health Science Center (US)
- Universidad de La Frontera (CL)
- Universidad de Guadalajara (MX)
- Medical University of South Carolina (US)
- Taichung Veterans General Hospital (TW)
- Bulgarian National Bank (BG)
- University of Cape Town (ZA)
- St. John's Research Institute (IN)
- Institute of Genetics and Cancer (GB)
- Oregon Health & Science University (US)
- Corresponding author
- Dagenais, Gilles R.
- ORCID
- Dagenais, Gilles R.
- Rydén, Lars
- Leiter, Lawrence A.
- Lakshmanan, Mark
- Probstfield, Jeffrey L.
- Shaw, Jonathan E.
- Conget, Ignacio
- Cushman, William C.
- Lanas, Fernando
- Basile, Jan
- Sheu, Wayne H. H.
- Temelkova-Kurktschiev, Theodora
- Raubenheimer, Peter J.
- Pais, Prem
- Colhoun, Helen M.
- Riddle, Matthew C.
- Gerstein, Hertzel C.
- Venue
- Cardiovascular Diabetology
- Published
- 2020-11-25
- Volume
- 19
- Issue
- 1
- Pages
- 199-199
- ISSN
- 1475-2840 (ISSN-L)
- PMC
- PMC7690176
- OpenAlex
- W3108967412
- Cited by
- 35
- References
- 31
- Citations by year
- 2026: 8 · 2025: 5 · 2024: 7 · 2023: 8 · 2022: 4 · 2021: 3
- FWCI
- 3.02
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Cardiovascular Diabetology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-nd)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
- Omeka S (Universidad de La Frontera) (submittedVersion, cc-by-nc-nd)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- dulaglutide, type 2 diabetes, major adverse cardiovascular events, GLP-1 receptor agonists, cardiovascular risk factors, cardiovascular mortality, non-cardiovascular mortality, REWIND trial, heart failure, revascularization, unstable angina, myocardial infarction, stroke, placebo
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Heart Disease Risk Factors, Glucagon-Like Peptide-1 Receptor Agonists, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Glucagon-Like Peptides, Female, Humans, Hypoglycemic Agents, Immunoglobulin Fc Fragments, Male, Middle Aged, Recombinant Fusion Proteins, Time Factors, Treatment Outcome, Risk Assessment, Incretins
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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