Saiseikai Toyama Hospital, Toyama, Japan.
Bristol-Myers Squibb K.K., Tokyo, Japan.
J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.
The safety and effectiveness of reduced-dose apixaban 2.5mg twice daily (BID) have not been elucidated thoroughly in Japanese patients with nonvalvular atrial fibrillation (NVAF).
A post-marketing survey study included NVAF patients who newly initiated apixaban for prevention of thromboembolism, and followed them for 104 weeks. Apixaban doses were selected at the discretion of treating physicians. Hemorrhagic and thromboembolic (ischemic stroke, systemic embolism, and transient ischemic attack) events were examined. The relationship between dose reduction criteria (DRC), selected doses, and outcome events was also examined.
Of 6306 patients, 3600 (57.1%) received the standard dose (5mg BID) and 2694 (42.7%) received the reduced dose. Compared with the standard-dose group, the reduced-dose group had more female patients; the patients were older, of lower body weight, with reduced creatinine clearance, higher thromboembolic and hemorrhagic risk scores, and more frequent antiplatelet use. Incidence rates of major hemorrhage and thromboembolism were higher in the reduced-dose group compared with the standard-dose group (3.00%/year vs 1.93%/year, p=0.001 and 1.40%/year vs 0.72%/year, p=0.001, respectively). In the standard-dose group, 90.0% of patients did not meet the DRC (recommended standard-dose group). In the reduced-dose group, 62.4% of patients met the DRC (recommended reduced-dose group) and 34.9% did not (non-recommended reduced-dose group). Incidence rates of major hemorrhage and thromboembolism were numerically highest in the recommended reduced-dose group (3.30%/year, p=0.007 and 1.69%/year, p<0.001, respectively), followed by the non-recommended reduced-dose group. In multivariate analysis, apixaban dose was not associated with these outcome events.
The reduced-dose group showed higher incidence rates of thromboembolic and major hemorrhagic events than the standard-dose group due to baseline clinical characteristics. The safety and effectiveness of reduced-dose apixaban need to be carefully monitored in clinical practice.
在非瓣膜性心房颤动（NVAF）的日本患者中，尚未充分阐明每日两次口服低剂量（2.5mg）阿哌沙班的安全性和有效性。
这是一项上市后调查研究，纳入了新开始使用阿哌沙班预防血栓栓塞的 NVAF 患者，并对他们进行了 104 周的随访。阿哌沙班的剂量由治疗医生决定。检查了出血和血栓栓塞（缺血性中风、全身性栓塞和短暂性脑缺血发作）事件。还检查了剂量减少标准（DRC）、选择的剂量和结果事件之间的关系。
在 6306 名患者中，3600 名（57.1%）接受了标准剂量（5mg BID），2694 名（42.7%）接受了低剂量。与标准剂量组相比，低剂量组的女性患者更多；患者年龄较大，体重较低，肌酐清除率较低，血栓栓塞和出血风险评分较高，抗血小板药物使用更频繁。与标准剂量组相比，低剂量组大出血和血栓栓塞的发生率更高（3.00%/年比 1.93%/年，p=0.001 和 1.40%/年比 0.72%/年，p=0.001）。在标准剂量组中，90.0%的患者未达到 DRC（推荐标准剂量组）。在低剂量组中，62.4%的患者达到 DRC（推荐低剂量组），34.9%的患者未达到 DRC（不推荐低剂量组）。在推荐的低剂量组中，大出血和血栓栓塞的发生率最高（3.30%/年，p=0.007 和 1.69%/年，p<0.001），其次是不推荐的低剂量组。多变量分析显示，阿哌沙班剂量与这些结局事件无关。
由于基线临床特征，低剂量组的血栓栓塞和大出血事件发生率高于标准剂量组。在临床实践中需要仔细监测低剂量阿哌沙班的安全性和有效性。
