Michela Brambatti1, Harald Darius2, Jonas Oldgren3, Andreas Clemens4, Herbert H Noack5, Martina Brueckmann6, Salim Yusuf7, Lars Wallentin3, Michael D Ezekowitz8, Stuart J Connolly7, Jeff S Healey7. 1. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Clinica di Cardiologia, Universita' Politecnica delle Marche, Ancona, Italy. Electronic address: michelabrambatti@gmail.com. 2. Vivantes Klinikum Neukölln, Berlin, Germany. 3. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 4. Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany; Center for Thrombosis and Hemostasis, University Medical Center, Mainz, Germany. 5. Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany. 6. Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany; Faculty of Medicine Mannheim of the University of Heidelberg, Germany. 7. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 8. Lankenau Institute for Medical Research, Wynnewood, PA.
Abstract
OBJECTIVE: Diabetes mellitus (DM) is frequent among patients with atrial fibrillation (AF). The RE-LY trial permits evaluation of patient characteristics, outcomes and the effectiveness of dabigatran etexilate among diabetic individuals. METHODS: Patient characteristics and outcomes were compared between diabetic and non-diabetic patients and the relative efficacy of each dose of dabigatran (150 mg bid and 110 mg bid) versus warfarin was evaluated. RESULTS: Of 18,113 patients in RE-LY, 4221 patients (23.3%) had DM. Patients with DM were younger (70.9 vs. 71.7 years), more likely to have hypertension (86.6% vs. 76.5%), coronary artery disease (37.4% vs. 24.9%) and peripheral vascular disease (5.6% vs. 3.2%); (all p<0.01). Time in therapeutic range for warfarin-treated patients was 65% for diabetic versus 68% for non-diabetic patients (p<0.001). Regardless of assigned treatment, stroke or systemic embolism was more common among patients with DM (1.9% per year vs. 1.3% per year, p<0.001). DM was also associated with an increased risk of death (5.1% per year vs. 3.5% per year, p<0.001) and major bleeding (4.2% per year vs. 3.0% per year, p<0.001). The absolute reduction in stroke or systemic embolism with dabigatran compared to warfarin was greater among patients with DM than those without DM (dabigatran 110 mg: 0.59% per year vs. 0.05% per year; dabigatran 150 mg: 0.89% per year vs. 0.51% per year). CONCLUSIONS: Compared to non-DM patients, AF patients with DM derive a greater absolute risk reduction in embolic events when treated with dabigatran. ClinicalTrials.gov Identifier: NCT00262600.
RCT Entities:
OBJECTIVE:Diabetes mellitus (DM) is frequent among patients with atrial fibrillation (AF). The RE-LY trial permits evaluation of patient characteristics, outcomes and the effectiveness of dabigatran etexilate among diabetic individuals. METHODS:Patient characteristics and outcomes were compared between diabetic and non-diabeticpatients and the relative efficacy of each dose of dabigatran (150 mg bid and 110 mg bid) versus warfarin was evaluated. RESULTS: Of 18,113 patients in RE-LY, 4221 patients (23.3%) had DM. Patients with DM were younger (70.9 vs. 71.7 years), more likely to have hypertension (86.6% vs. 76.5%), coronary artery disease (37.4% vs. 24.9%) and peripheral vascular disease (5.6% vs. 3.2%); (all p<0.01). Time in therapeutic range for warfarin-treated patients was 65% for diabetic versus 68% for non-diabeticpatients (p<0.001). Regardless of assigned treatment, stroke or systemic embolism was more common among patients with DM (1.9% per year vs. 1.3% per year, p<0.001). DM was also associated with an increased risk of death (5.1% per year vs. 3.5% per year, p<0.001) and major bleeding (4.2% per year vs. 3.0% per year, p<0.001). The absolute reduction in stroke or systemic embolism with dabigatran compared to warfarin was greater among patients with DM than those without DM (dabigatran 110 mg: 0.59% per year vs. 0.05% per year; dabigatran 150 mg: 0.89% per year vs. 0.51% per year). CONCLUSIONS: Compared to non-DMpatients, AFpatients with DM derive a greater absolute risk reduction in embolic events when treated with dabigatran. ClinicalTrials.gov Identifier: NCT00262600.
Authors: Ramzi A Ajjan; Noppadol Kietsiriroje; Lina Badimon; Gemma Vilahur; Diana A Gorog; Dominick J Angiolillo; David A Russell; Bianca Rocca; Robert F Storey Journal: Eur Heart J Date: 2021-06-14 Impact factor: 29.983
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