Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial

Int J Cardiol. 2015 Oct 1;196:127-31. doi: 10.1016/j.ijcard.2015.05.141. Epub 2015 May 28.


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. Identifier: NCT00262600.

Keywords: Atrial fibrillation; Dabigatran; Diabetes mellitus; Oral anticoagulation; Stroke; Warfarin.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / therapeutic use*
  • Antithrombins / therapeutic use*
  • Atrial Fibrillation / drug therapy*
  • Comorbidity
  • Dabigatran / therapeutic use*
  • Diabetes Mellitus / drug therapy*
  • Drug Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Risk Factors
  • Stroke / prevention & control
  • Warfarin / therapeutic use*


  • Anticoagulants
  • Antithrombins
  • Warfarin
  • Dabigatran

Associated data