Abstract
The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess ‘real world’ efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013. Data was available for 510 patients: median age 68 years (range 20–91), median CHA2DS2-VASc score was 2 and median HAS-BLED score was 2. The average follow-up duration of 315 days (range: 1–1,096). The overall discontinuation rate was 16 % after a median 252 days of treatment with dabigatran. There were 17 (3.3 %) patients with minor bleeding, 2 (0.4 %) had major bleeding episodes. 20 patients (3.9 %) developed dyspepsia which was the most common side effect. The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial. None of the patients had an ischaemic stroke, 1 (0.2 %) patient had a haemorrhagic stroke. Out of 510 patients, 158 patients (31 %) were switched to dabigatran from warfarin. This showed that patients frequently preferred the dabigatran due to convenience when given a choice to switch from warfarin. We report one of the largest registry of Asian patients. Reassuringly, we found that our cohort had a low rate of rate of ischaemic stroke, low rates of side effects and bleeding with the drug.
Similar content being viewed by others
References
Boehringer Ingelheim. Pradaxa 110 mg: summary of product characteristics. http://www.medicines.org.uk/emc/medicine/20760 Accessed 22 Oct 2013
Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation (RE-LY). N Engl J Med 361:1139–1151
Connolly SJ, Wallentin L, Ezekowitz MD et al (2013) The long term multi-center observational study of dabigatran treatment in patients with atrial fibrillation: (RELY-ABLE) study. Circulation 128(3):237–243
Patel MR, Mahaffey KW, Garg J et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (with supplementary appendix). N Engl J Med 365:883–891
Granger CB, Alexander JH, McMurray JJV et al (2011) Apixaban versus warfarin in patients with atrial fibrillation (including supplementary appendix and study protocol). N Engl J Med 365:981–992
Camm AJ, Lip GYH, De Caterina R et al (2012) 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Europace 14:1385–1413
Camm J, Kirchhof P, Lip G et al (2010) Guidelines for the management of atrial fibrillation. The task force for the management of atrial fibrillation of the European Society of Cardiology (ESC). Eur Heart J 31:2369–2429
Shen AY, Yao JF, Brar SS et al (2007) Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 50(4):309–315
Guo Y, Pisters R, Apostolakis S et al (2013) Stroke risk and suboptimal thromboprophylaxis in Chinese patients with atrial fibrillation: Would the novel oral anticoagulants have an impact? Int J Cardiol 168(1):515–522
Truumees E, Gaudu T, Dieterichs C et al (2012) Epidural hematoma and intraoperative hemorrhage in a spine trauma patient on Pradaxa (dabigatran). Spine 37:E863–E865
Wychowski MK, Kouides PA (2012) Dabigatran-induced gastrointestinal bleeding in an elderly patient with moderate renal impairment. Ann Pharmacother 46:e10
Flaker G, Ezekowitz M, Yusuf S et al (2012) Efficacy and safety of dabigatran compared to warfarin in patients with paroxysmal, persistent, and permanent atrial fibrillation: results from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study. J Am Coll Cardiol 59(9):854–855
Lakkireddy D, Reddy YM, Di Biase L et al (2012) Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 59(13):1168–1174
Nagarakanti R, Ezekowitz MD, Oldgren J et al (2011) Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation 123(2):131–136
Hori M, Connolly SJ, Zhu J, The RE-LY Investigators et al (2013) Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and Non-Asians with atrial fibrillation. Stroke 44(7):1891–1896
Wallentin L, Yusuf S, Ezekowitz MD, RE-LY investigators et al (2010) 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 376(9745):975–983
Ho JC, Chang AM, Yan BP, Yu CM, Lam YY, Lee VW (2012) Dabigatran compared with warfarin for stroke prevention with atrial fibrillation: experience in Hong Kong. Clin Cardiol 35(12):E40–E45
Larsen TB, Rasmussen LH, Skjøth F et al (2013) Efficacy and safety of dabigatran etexilate and warfarin in ‘real world’ patients with atrial fibrillation: A prospective nationwide cohort study. J Am Coll Cardiol 61(22):2264–2273
Michel J, Mundell D, Boga T et al (2013) Dabigatran for anticoagulation in atrial fibrillation—early clinical experience in a hospital population and comparison to trial data. Heart Lung Circ 22:50–55
Conflict of interest
The authors declare that they have no conflict of interest.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Yap, L.B., Rusani, B.I., Umadevan, D. et al. A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation. J Thromb Thrombolysis 38, 39–44 (2014). https://doi.org/10.1007/s11239-013-1020-y
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11239-013-1020-y