General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.
School of Medicine, National Yang-Ming University, Taipei, Taiwan.
J Formos Med Assoc. 2017 Aug;116(8):591-598. doi: 10.1016/j.jfma.2017.05.015. Epub 2017 Jun 20.
BACKGROUND/PURPOSE: Non-vitamin K antagonist oral anticoagulants (NOACs) have a half-life of around 12 h. We aimed to clarify if there was any effect modification by dosing (once- or twice-daily) regimens in Asian patients.
Phase III randomized controlled trials of NOACs compared with warfarin in Asian patients with atrial fibrillation (AF) were identified and extracted from PubMed, CENTRAL, and CINAHL databases through November 2016. Outcomes were pooled by dosing regimens with the Mantel-Haenszel fixed-effects model. The risk ratio (RR) and 95% confidence interval (CI) were calculated. Effect differences between once- and twice-daily NOACs were assessed with Bucher indirect comparisons using common estimates, once heterogeneity was low, and with the Bayesian method.
From 6 trials, there was no effect modification by dosing regimens in the risk of stroke or systemic embolism across ethnicities (all interaction P > 0.05). Both dosing regimens were associated with a greater reduction in the risk of major bleeding in Asian patients (RR, 0.63 (95% CI, 0.47-0.85) and 0.57 (95% CI, 0.43-0.75), for once- and twice-daily NOACs, respectively). In Asian patients, risks of hemorrhagic stroke and intracranial hemorrhage were lower with once- (RR, 0.41 (95% CI, 0.21-0.80) and 0.29 (95% CI, 0.16-0.53)) and twice-daily NOACs (RR, 0.25 (95% CI, 0.12-0.51) and 0.38 (95% CI, 0.23-0.65)), compared with warfarin. There was no effect difference favoring any of NOAC regimens evaluated by Bucher and Bayesian methods.
In Asian patients with AF, NOACs, regardless of dosing regimens, have a similar feature of preserved efficacy with improved safety compared with warfarin.
背景/目的：非维生素 K 拮抗剂口服抗凝剂（NOACs）的半衰期约为 12 小时。我们旨在阐明在亚洲患者中，给药方案（每日一次或每日两次）是否存在任何影响修饰作用。
通过 2016 年 11 月前从 PubMed、CENTRAL 和 CINAHL 数据库中确定并提取了比较亚洲房颤（AF）患者中 NOACs 与华法林的 III 期随机对照试验。通过 Mantel-Haenszel 固定效应模型按给药方案汇总结果。计算风险比（RR）和 95%置信区间（CI）。如果异质性低，使用 Bucher 间接比较和常用估计值评估每日一次和每日两次 NOAC 之间的效果差异，并使用贝叶斯方法。
从 6 项试验中，在种族间的中风或全身性栓塞风险方面，给药方案没有影响修饰作用（所有交互 P>0.05）。两种给药方案均与亚洲患者大出血风险降低相关（RR，0.63（95%CI，0.47-0.85）和 0.57（95%CI，0.43-0.75），分别用于每日一次和每日两次的 NOAC）。在亚洲患者中，与华法林相比，每日一次（RR，0.41（95%CI，0.21-0.80）和 0.29（95%CI，0.16-0.53））和每日两次的 NOAC（RR，0.25（95%CI，0.12-0.51）和 0.38（95%CI，0.23-0.65））出血性中风和颅内出血的风险较低。通过 Bucher 和贝叶斯方法评估，没有任何一种 NOAC 方案具有优势的效果差异。
在亚洲 AF 患者中，与华法林相比，无论给药方案如何，NOACs 都具有相似的疗效特征，且安全性得到改善。
