Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglu
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ORIGINAL INVESTIGATION
Cardiovascular Diabetology Open Access
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 Gilles R. Dagenais1* , Lars Rydén2, Lawrence A. Leiter3, Mark Lakshmanan4, Leanne Dyal5, Jeffrey L. Probstfield6, Charles Messan Atisso4, Jonathan E. Shaw7, Ignacio Conget8, William C. Cushman9, Patricio Lopez‑Jaramillo10, Fernando Lanas11, Ernesto German Cordona Munoz12, Valdis Pirags13, Nana Pogosova14, Jan Basile15, Wayne H. H. Sheu16, Theodora Temelkova‑Kurktschiev17, Peter J. Raubenheimer18, Matyas Keltai19, Stephanie Hall5, Prem Pais20, Helen M. Colhoun21, Matthew C. Riddle22 and Hertzel C. Gerstein5
Abstract Background: The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind rand‑ omized 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].
*Correspondence: [email protected] 1 Clinical Research Center, Laval University, Quebec Heart and Lung Institute, 2725, chemin Ste‑Foy, Quebec City, Qc GIV 4G5, Canada Ful
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