title: Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial.
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.
authors.affiliation: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Clinica di Cardiologia, Universita' Politecnica delle Marche, Ancona, Italy. Electronic address: michelabrambatti@gmail.com.
authors.forename: Michela
authors.initials: M
authors.lastname: Brambatti
authors.affiliation: Vivantes Klinikum Neukölln, Berlin, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Darius
authors.affiliation: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Oldgren
authors.affiliation: Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany; Center for Thrombosis and Hemostasis, University Medical Center, Mainz, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Herbert H
authors.initials: HH
authors.lastname: Noack
authors.affiliation: Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany; Faculty of Medicine Mannheim of the University of Heidelberg, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.affiliation: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.affiliation: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.affiliation: Lankenau Institute for Medical Research, Wynnewood, PA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.affiliation: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.affiliation: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D015897:Comorbidity; D000069604:Dabigatran / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D020521:Stroke / Q000517:prevention & control; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D014859:Warfarin; D000069604:Dabigatran
keywords: Atrial fibrillation; Dabigatran; Diabetes mellitus; Oral anticoagulation; Stroke; Warfarin