title: Dabigatran or warfarin for the prevention of stroke in atrial fibrillation? A closer look at the RE-LY trial.
abstract: BACKGROUND
  In the Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) trial, dabigatran 150 mg was shown to be superior to warfarin for the prevention of stroke or systemic embolism. However, there are some concerns with the RE-LY trial, such as its open-label design, potential unblinding of "blinded" adjudicators, the use of concomitant warfarin-aspirin (ASA), the disparity between baseline use of nonselective NSAIDs; the high unequal rate of drop-outs; unaccounted drop-ins; high rates of major bleeds in warfarin-treated patients, despite being a low risk population; and rates of major bleeds that do not match historic warfarin trials. Furthermore, although dabigatran offers potential advantages versus warfarin, there are disadvantages that must be taken into consideration before a patient is switched from the latter to the former. This review will summarize the flaws of the RE-LY trial as well as the clinically important advantages and disadvantages of dabigatran and warfarin.
  
  
  METHODS
  This review examines the differences between dabigatran and warfarin in terms of side effects, drug-drug interactions, drug-food interactions, and potential reasons for using one anticoagulant rather than the other. The main focus of this review is a discussion of the design, procedures and results of the RE-LY trial.
  
  
  CONCLUSIONS
  There seem to be major flaws with the RE-LY trial. A double-blinded trial should be performed testing dabigatran against warfarin to verify the results of the RE-LY trial.
authors.affiliation: Wegmans Pharmacy, 500 South Meadow Street Ithaca, Ithaca, NY 14850, USA. jjdinicol@gmail.com
authors.forename: James J
authors.initials: JJ
authors.lastname: DiNicolantonio
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D001562:Benzimidazoles / Q000627:therapeutic use*; D000069604:Dabigatran; D004347:Drug Interactions; D006801:Humans; D020521:Stroke / Q000517:prevention & control*; D014859:Warfarin / Q000627:therapeutic use*; D015091:beta-Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran