International University of Health and Welfare, Mita Hospital, Japan.
Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.
Guidelines recommend warfarin as the standard of care for patients with atrial fibrillation (AF) at moderate or high risk for stroke. This phase II study assessed the effects of 2 doses of the factor Xa inhibitor apixaban vs. warfarin in Japanese patients with non-valvular AF. The composite primary endpoint was major and clinically relevant non-major (CRNM) bleeding.
Two hundred and twenty-two patients with AF and 1 or more additional risk factors for stroke were randomized (1:1:1) to double-blind apixaban 2.5 or 5mg b.i.d. or open-label warfarin (target international normalized ratio 2.0-3.0; 2.0-2.6 if age ≥ 70 years) for 12 weeks. The primary endpoint occurred in 1 patient (1.4%) in each apixaban group and 4 (5.3%) warfarin patients. There were no strokes, systemic emboli, myocardial infarctions, or deaths in either apixaban group. The warfarin group had 2 ischemic strokes and 1 subarachnoid hemorrhage, but there were no deaths. Major and CRNM bleeds each occurred with higher frequency in the warfarin group vs. either apixaban group. Most adverse events were mild or moderate. No patients had hepatic aminotransferase elevations greater than 3 times the upper limit of normal.
In Japanese patients with AF, apixaban 2.5 and 5mg b.i.d. were well tolerated over 12 weeks. A global phase III trial, which includes Japanese patients, is ongoing (ClinicalTrials.gov Identifier NCT00787150).
指南推荐华法林作为中高危房颤（AF）患者的标准治疗方法。这项 II 期研究评估了两种剂量的因子 Xa 抑制剂阿哌沙班与华法林在日本非瓣膜性 AF 患者中的效果。复合主要终点是主要和临床相关非主要（CRNM）出血。
222 名 AF 患者和 1 个或多个其他中风危险因素被随机分为（1:1:1）双盲阿哌沙班 2.5 或 5mg 每日两次或开放标签华法林（目标国际标准化比值 2.0-3.0；年龄≥70 岁时为 2.0-2.6）治疗 12 周。主要终点在每个阿哌沙班组各发生 1 例（1.4%），华法林组发生 4 例（5.3%）。阿哌沙班组均未发生中风、全身性栓塞、心肌梗死或死亡。华法林组有 2 例缺血性中风和 1 例蛛网膜下腔出血，但无死亡。大出血和 CRNM 出血在华法林组的发生率均高于阿哌沙班组。大多数不良事件为轻度或中度。无患者的肝转氨酶升高超过正常值上限的 3 倍。
在日本 AF 患者中，阿哌沙班 2.5 和 5mg 每日两次治疗 12 周耐受性良好。一项包括日本患者的全球 III 期试验正在进行中（ClinicalTrials.gov 标识符 NCT00787150）。
