Special considerations for therapeutic choice of non-vitamin K antagonist oral anticoagulants for Japanese patients with nonvalvular atrial fibrillation.
Special considerations for therapeutic choice of non-vitamin K antagonist oral anticoagulants for Japanese patients with nonvalvular atrial fibrillation.
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DOI：
10.1002/clc.22596
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发表时间：
2017-02
影响因子：
2.7
通讯作者：
John Camm A
中科院分区：
文献类型：
--
作者：
Okumura K;Hori M;Tanahashi N;John Camm A
非瓣膜性房颤(AF)是老年患者卒中的危险因素。尽管华法林用于预防房颤相关卒中已有50多年的历史，但最近已开发出非维生素K拮抗剂(NOAC)，包括达比卡特兰、利伐沙班、阿皮沙班和依多沙班，以克服华法林的缺点。根据NOAC临床试验的结果，Savelieva和Camm就非瓣膜性房颤患者NOAC的选择提出了建议。最近积累的证据表明，NOAC在亚洲人和非亚洲人中的作用不同。在这篇综述中，我们讨论了关于NOAC的大型、随机、国际3期临床试验的结果，亚洲人的亚分析，以及日本利伐沙班的3期临床试验，以区分日本患者对NOAC的反应特点，并提出建议。我们的分析表明，与华法林相比，利伐沙班降低了日本患者胃肠道(GI)出血的发生率。疗效结果显示，与华法林相比，利伐沙班显著降低了缺血性卒中的发生率(危险比：0.40，95%可信区间：0.17~0.96)。消化道出血和缺血性中风的较低发生率可能是日本患者特有的。根据目前和以前的结果，在日本患者的CAMM图表中增加了以下关于选择NOAC的建议：Edoxaban适用于出血风险高的患者和既往中风患者；利伐沙班适用于高风险缺血性中风和低出血风险患者以及既往胃肠道出血患者。
Nonvalvular atrial fibrillation (AF) is a risk factor for stroke in elderly patients. Although warfarin has been used to prevent AF‐associated stroke for more than 50 years, non–vitamin K antagonist oral anticoagulants (NOACs) including dabigatran, rivaroxaban, apixaban, and edoxaban recently have been developed to overcome the disadvantages of warfarin. Based on the results of NOAC clinical trials, Savelieva and Camm made recommendations regarding selection of NOACs in patients with nonvalvular AF. Recent accumulating evidence indicates that NOACs work differently in Asian and non‐Asian individuals. In this review, we discuss the results of the large, randomized, phase 3 international clinical trials on NOACs, the subanalyses of Asians, and a Japanese phase 3 clinical trial of rivaroxaban to discriminate Japanese patient–specific characteristics with regard to their responses to NOACs and make recommendations. Our analysis revealed that rivaroxaban decreased the incidence of gastrointestinal (GI) bleeding compared with warfarin in Japanese patients. The efficacy results showed that rivaroxaban significantly decreased the incidence of ischemic stroke (hazard ratio: 0.40, 95% confidence interval: 0.17‐0.96) compared with warfarin. The lower incidence of GI bleeding and ischemic stroke may be specific to Japanese patients. Based on the present and previous results, the following recommendations regarding the selection of NOACs are added in the Camm chart for Japanese patients: edoxaban for patients with a high risk of bleeding and those with a previous stroke; and rivaroxaban for patients with a high risk of ischemic stroke and a low bleeding risk, and those with previous GI bleeding.