A new drug with great promise, but be very aware of the risks
Dabigatran is the first new oral anticoagulant for the prevention of embolism in patients with non-valvular atrial fibrillation (AF) that has been recently approved in Australia (Therapeutic Goods Administration, 1 April 2011) and New Zealand (PHARMAC, 1 July 2011), based on the results of the RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study.1 It is an attractive alternative to warfarin because it has a rapid onset of action (2–3 hours), a wide therapeutic range, predictable pharmacokinetics (half-life of 12–17 hours), limited drug interactions and no food interactions. Unlike warfarin, these features allow fixed doses and no requirement for routine laboratory monitoring.1
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- 1. Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151.
- 2. Eikelboom JW, Wallentin L, Connelly 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.
- 3. Baker RI, Coughlin PB, Gallus AS, et al; Warfarin Reversal Consensus Group. Warfarin reversal: consensus guidelines, on behalf of the Australasian Society of Thrombosis and Haemostasis. Med J Aust 2004; 181: 492-497. <MJA full text>
- 4. Levi M, Eerenberg E, Kamphuisen PW. Bleeding risk and reversal strategies for old and new anticoagulants and antiplatelet agents. J Thromb Haemost 2011; 9: 1705-1712. doi: 10.1111/j.1538-7836.2011.04432.x.
- 5. Liesenfeld KH, Lehr T, Dansirikul C, et al. Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial. J Thromb Haemost 2011; 9: 2168-2175. doi: 10.1111/j.1538-7836.2011.04498.x.
- 6. Miyasaka Y, Barnes ME, Gersh BJ, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projection for future prevalence. Circulation 2006; 114: 119-125.
- 7. Legrand M, Mateo J, Aribaud A, et al. The use of dabigatran in elderly patients. Arch Intern Med 2011; 171: 1285-1286.
- 8. Harper P, Young L, Merriman E. Bleeding risk with dabigatran in the frail elderly. N Eng J Med 2012; 366: 864-865.
- 9. Melloni C, Peterson ED, Chen AY, et al. Cockcroft-Gault versus modification of diet in renal disease: importance of glomerular filtration rate formula for classification of chronic kidney disease in patients with non-ST-segment elevation acute coronary syndromes. J Am Coll Cardiol 2008; 51: 991-996.
- 10. Alberts MJ, Bernstein RA, Naccarelli GV, Garcia DA. Using dabigatran in patients with stroke: a practical guide for clinicians. Stroke 2012; 43: 271-279.
Ross Baker has undertaken clinical trials with the new anticoagulants for Boehringer Ingelheim, Bayer, Pfizer, Daiichi Sankyo, Astellas and CSL, and has served on advisory boards for Boehringer Ingelheim, Bayer and Pfizer. Paul Harper has received honoraria for educational lectures from Bayer.