There are limited data evaluating the safety and efficacy of dabigatran 110 mg twice daily in patients with atrial fibrillation (AF). The Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial represents the largest available data set, in which dabigatran 110 mg was associated with rates of stroke and systemic embolism similar to warfarin, but with lower rates of major hemorrhage. Notably, findings from an age-stratified post hoc analysis of the RE-LY trial demonstrated that b...
According to the 2024 European Society of Cardiology (ESC) guidelines for the management of atrial fibrillation, dabigatran 110 mg twice daily is recommended for patients aged ≥80 years and for those receiving concomitant verapamil. Dose reduction to 110 mg twice daily should also be considered on an individual basis for patients aged 75-80 years, those with moderate renal impairment (creatinine clearance [CrCl] 30-50 mL/min), patients with gastritis, esophagitis, or gastroesophageal reflux disease, and those at increased risk of bleeding. In patients with acute coronary syndromes or those undergoing percutaneous coronary intervention, dabigatran 110 mg twice daily should be considered in preference to dabigatran 150 mg twice daily when used in combination with antiplatelet therapy if concerns about bleeding risk outweigh concerns regarding stent thrombosis or ischemic stroke. [1]
A 2017 systematic review and meta-analysis conducted analyzed bleeding events associated with two dif...
READ MORE→
A search of the published medical literature revealed
3 studies investigating the researchable question:
What is the evidence for the efficacy and safety of dabigatran 110 mg twice daily, compared with warfarin, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
Level of evidence
C - Multiple studies with limitations or conflicting results
READ MORE→
[1] Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176
[2] Bundhun PK, Chaudhary N, Yuan J. Bleeding events associated with a low dose (110 mg) versus a high dose (150 mg) of dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2017;17(1):83. Published 2017 Mar 15. doi:10.1186/s12872-017-0511-8
[3] Connolly SJ, Wallentin L, Ezekowitz MD, et al. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013;128(3):237-243. doi:10.1161/CIRCULATIONAHA.112.001139
[4] 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(21):2363-2372.
[5] Lauw MN, Eikelboom JW, Coppens M, et al. Effects of dabigatran according to age in atrial fibrillation. Heart. 2017;103(13):1015-1023. doi:10.1136/heartjnl-2016-310358
[6] Hori M, Connolly SJ, Ezekowitz MD, et al. Efficacy and safety of dabigatran vs. warfarin in patients with atrial fibrillation--sub-analysis in Japanese population in RE-LY trial. Circ J. 2011;75(4):800-805. doi:10.1253/circj.cj-11-0191