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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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.