Cardiovascular Medicine, Chonnam National University Hospital, 42 Jaebong-ro, Dong-gu, Gwangju 61469, South Korea.
Europace. 2017 Dec 1;19(suppl_4):iv1-iv9. doi: 10.1093/europace/eux247.
We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF).
We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar.
Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF.
我们旨在确定韩国房颤（AF）患者达比加群的最佳剂量。
我们分析了 1834 名非瓣膜性房颤患者，分为华法林组（n=990）、达比加群 150mg 组（D150，n=294）和 110mg 组（D110，n=550）。D110 组进一步分为与剂量减少指南一致的患者（co-D110，n=367）和不一致的患者（di-D110，n=183）。然后比较了倾向性匹配的 1 年临床结局。疗效结果定义为新发卒中和全身性栓塞组成的血栓栓塞。安全性结果为大出血。D150 和 D110 的疗效与华法林相当。然而，只有 D110 显著降低了大出血的风险[风险比（HR）0.19，95%置信区间（CI）0.07-0.55，P=0.002]。根据剂量减少指南一致的适应证进行亚组分析，co-D110 和 di-D110 的疗效与华法林相当。co-D110（HR 0.22，95%CI 0.06-0.76，P=0.017）和 di-D110（HR 0.11，95%CI 0.02-0.81，P=0.030）均显著降低了大出血的发生率。di-D110 和 D150 之间的疗效和安全性无差异，净临床结局相似。
尽管 D150 和 D110 的疗效相当，但与华法林相比，只有 D110 降低了韩国 AF 患者大出血的风险。即使达比加群 110mg 与指南不符，与 D150 相比，其疗效和安全性也相似。然而，为了全面评估达比加群 150 或 110mg 对亚洲 AF 患者是否为最佳剂量，还需要进一步的前瞻性随机试验。
