To the Editor: In 2009, the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial compared dabigatran etexilate with warfarin for prevention of stroke and systemic embolism in 18 113 patients with non-valvular atrial fibrillation (AF) and at least one additional risk factor for stroke.1 In April 2011, it became accessible in Australia (Pradaxa; Boehringer Ingelheim) under a product familiarisation program funded by the manufacturer; however, the Pharmaceutical Benefits Advisory Committee expressed concern that without informed and appropriate prescription, clinical trial outcomes may not be reproducible.2 Case reports from Europe3 and New Zealand4 identified the need for caution when treating older patients, those with low body weight or patients with renal impairment because of the risk of serious bleeding.
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- 1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151.
- 2. Department of Health and Ageing. Important new medicines listed on the PBS. http://www.health. gov.au/internet/ministers/publishing.nsf/Content/mr-yr11-nr-nr196.htm (accessed Sep 2011).
- 3. Legrand M, Mateo J, Aribaud A, et al. The use of dabigatran in elderly patients. Arch Intern Med 2011; 171: 1285-1286.
- 4. Harper P, Young L, Merriman E. Bleeding risk with dabigatran in the frail elderly. N Engl J Med 2012; 366: 864-866.
- 5. Wallentin L, Yusuf S, Ezekowitz MD, et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010; 376: 975-983.
We would like to thank Duncan Carradice for proofreading the original paper and providing constructive advice, and Shaun Fleming for his help with data collection.
No relevant disclosures.