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.

Autor: Dagenais GR; Clinical Research Center, Laval University, Quebec Heart and Lung Institute, 2725, chemin Ste-Foy, Quebec City, Qc, GIV 4G5, Canada. gilles.dagenais@criucpq.ulaval.ca., Rydén L; Department of Medicine Solna, Karolinska Institute, Stockholm, Sweden., Leiter LA; Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada., Lakshmanan M; Eli Lilly and Company, Indianapolis, In, USA., Dyal L; Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada., Probstfield JL; Department of Medicine (Cardiology), University of Washington Medical Centre, Seattle, WA, USA., Atisso CM; Eli Lilly and Company, Indianapolis, In, USA., Shaw JE; Baker Heart and Diabetes Institute, Melbourne, VIC, Australia., Conget I; Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain., Cushman WC; Department of Medicine, University of Tennessee Health Science, Memphis, TN, USA., Lopez-Jaramillo P; Masira Research Institute, Medical School, Universidad de Santander UDES, Bucaramanga, Colombia., Lanas F; Universidad de la Frontera, Temuco, Chile., Munoz EGC; Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico., Pirags V; Latvijas Universitate, Riga, Latvia., Pogosova N; National Medical Research Centre of Cardiology, Moscow, Russia., Basile J; Medical University of South Carolina, Charleston and Ralph H Johnson VA Medical Center, Charleston, SC, USA., Sheu WHH; Endocrinology and Metabolism, Taichung Veterans General Hospital, Taichung, Taiwan., Temelkova-Kurktschiev T; Robert Koch Medical Centre, Sofia, Bulgaria., Raubenheimer PJ; Department of Medicine, University of Cape Town, Cape Town, South Africa., Keltai M; Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary., Hall S; Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada., Pais P; St John's Research Institute, Bangalore, India., Colhoun HM; MRC Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK., Riddle MC; Department of Medicine, Oregon and Health Science University, Portland, OR, USA., Gerstein HC; Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada.
Jazyk: angličtina
Zdroj: Cardiovascular diabetology [Cardiovasc Diabetol] 2020 Nov 25; Vol. 19 (1), pp. 199. Date of Electronic Publication: 2020 Nov 25.
DOI: 10.1186/s12933-020-01179-1
Abstrakt: 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).
Databáze: MEDLINE
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