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Is there really misuse and abuse of dabigatran?

John W Eikelboom and Graeme J Hankey
Med J Aust 2013; 198 (7): 358-359. || doi: 10.5694/mja12.11642
Published online: 15 April 2013

A brief commentary on the RE-LY study

Patient selection in the RE-LY trial

The RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial of dabigatran versus warfarin included patients with all degrees of risk of stroke and systemic embolism.9 If the trial had excluded participants with a low risk, ie, a CHADS2 score of 1 (congestive heart failure, hypertension, age ≥ 75 years, diabetes, 1 point each; prior stroke or transient ischaemic attack, 2 points), clinicians would not now know that these patients derive benefit from dabigatran compared with warfarin.


Provenance: Commissioned; externally peer reviewed.

  • John W Eikelboom1
  • Graeme J Hankey2

  • 1 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • 2 School of Medicine and Pharmacology, University of Western Australia, Perth, WA.


Correspondence: eikelbj@mcmaster.ca

Competing interests:

John Eikelboom was a member of the RE-LY Steering Committee and has received honoraria and grant support from the manufacturers of new oral anticoagulants including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Janssen and Pfizer. Graeme Hankey has received honoraria for serving on the executive steering committees of the ROCKET-AF trial (Johnson and Johnson), the AMADEUS and BOREALIS trials (Sanofi), and the stroke outcome adjudication committees of the RE-LY trial and AVERROES trial, and has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Pfizer for speaking at sponsored scientific symposia and consulting on advisory boards.

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  • 2. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-891.
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  • 10. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2011; 123: 2363-2372.
  • 11. Healey JS, Eikelboom J, Douketis J, et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation 2012; 126: 343-348.
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  • 15. Food and Drug Administration. FDA drug safety communication: update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran). http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm (accessed Feb 2013).

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