University of Athens, School of Medicine, Iras 39, Gerakas Attikis, Athens, 15344, Greece.
Department of Neurology, St. Josef-Hospital, Ruhr University, Bochum, Germany.
Ther Adv Neurol Disord. 2014 May;7(3):155-61. doi: 10.1177/1756285614528064.
There are growing concerns for the side effects of dabigatran etexilate (dabigatran), including higher incidence of dyspepsia and gastrointestinal bleeding. We conducted a multicenter early implementation study to prospectively evaluate the safety, efficacy and adherence to dabigatran for secondary stroke prevention.
Consecutive atrial fibrillation (AF) patients with ischemic stroke (IS) or transient ischemic attack (TIA) received dabigatran for secondary stroke prevention during their hospital stay according to American Heart Association recommendations at five tertiary care stroke centers. The study population was prospectively followed and outcomes were documented. The primary and secondary safety outcomes were major hemorrhage and all other bleeding events respectively defined according to RE-LY trial methodology.
A total of 78 AF patients (mean age 71 ± 9years; 54% men; 81% IS, 19% TIA; median CHADS2 (Congestive heart failure, Hypertension, diabetes mellitus, age >75 years, prior stroke or TIA); range 2-5) score 4 were treated with dabigatran [(110mg bid (74%); 150mg bid (26%)]. During a mean follow-up period of 7 ± 5 months (range 1-18) we documented no cases of IS, TIA, intracranial hemorrhage, systemic embolism or myocardial infarction in AF patients treated with dabigatran. There were two (2.6%) major bleeding events (lower gastrointestinal bleeding) and two (2.6%) minor bleedings [hematuria (n = 1) and rectal bleeding (n = 1)]. Dabigatran was discontinued in 26% of the study population with high cost being the most common reason for discontinuation (50%).
Our pilot data indicate that dabigatran appears to be safe for secondary stroke prevention during the first year of implementation of this therapy. However, high cost may limit the long-term treatment of AF patients with dabigatran, leading to early discontinuation.
达比加群酯（dabigatran）的副作用问题引起了越来越多的关注，包括消化不良和胃肠道出血发生率升高。我们开展了一项多中心早期应用研究，旨在前瞻性评估达比加群用于二级预防卒中的安全性、疗效和患者服药依从性。
在 5 家三级卒中中心，根据美国心脏协会的建议，连续入组因缺血性卒中（IS）或短暂性脑缺血发作（TIA）住院的房颤（AF）患者，接受达比加群进行二级预防卒中。前瞻性随访研究人群并记录结局。主要和次要安全性结局分别为大出血和所有其他出血事件，定义方法依据 RE-LY 试验。
共纳入 78 例 AF 患者（平均年龄 71 ± 9 岁；54%为男性；81%为 IS，19%为 TIA；中位数 CHADS2 评分[充血性心力衰竭、高血压、糖尿病、年龄>75 岁、既往卒中或 TIA；范围 2-5]为 4），接受达比加群治疗[110mg，每日 2 次（74%）；150mg，每日 2 次（26%）]。平均随访 7 ± 5 个月（范围 1-18）期间，AF 患者未发生 IS、TIA、颅内出血、全身性栓塞或心肌梗死。有 2 例（2.6%）大出血事件（下消化道出血）和 2 例（2.6%）小出血事件[血尿（n=1）和直肠出血（n=1）]。有 26%的研究人群中断了达比加群治疗，费用高是最常见的停药原因（50%）。
我们的初步数据表明，在该治疗方案实施的第一年，达比加群似乎是安全的，可用于二级预防卒中。然而，高费用可能会限制长期使用达比加群治疗 AF 患者，导致早期停药。
