Nakamura Mashio, Yamada Norikazu, Asamura Tomohiko, Shiosakai Kazuhito, Uchino Kazuhiro
Department of Internal Medicine, Pediatrics and Cardiology, Nakamura Medical Clinic Kuwana Japan.
Department of Cardiology, Kuwana City Medical Center Kuwana Japan.
Circ Rep. 2020 Feb 6;2(3):192-202. doi: 10.1253/circrep.CR-19-0127.
ETNA-VTE-Japan is a prospective, observational study conducted as part of a postmarketing study regarding the safety and effectiveness of edoxaban in Japanese patients with venous thromboembolism (VTE). The results of the final analysis of data collected at 1 year are presented. A total of 1,732 patients were included in this study. The safety and effectiveness were evaluated in 1,702 patients (safety analysis set; SAS) and in 1,698 patients (effectiveness analysis set). In the SAS, 39.4% of patients were aged ≥75 years, 58.2% had body weight ≤60 kg, and 22.2% had creatinine clearance <50 mL/min. Approximately 90% of patients received a dose recommended on the package insert. A total of 46.1% of patients continued treatment for 1 year, with mean and median treatment periods of 235.8 and 263.0 days, respectively. The incidence of bleeding adverse events (AE) was 10.3%; major bleeding, 2.6%; and VTE recurrence, 1.8%. The risk factor commonly associated with bleeding AE and VTE recurrence was cancer. The safety and effectiveness profiles of edoxaban in patients receiving the appropriate low dose (30 mg/day), generally used in patients with high bleeding risk, were similar to those for the appropriate standard dose (60 mg/day). At 1 year of treatment, there were no major concerns regarding the safety and effectiveness of edoxaban in Japanese patients with VTE.
ETNA-VTE-日本研究是一项前瞻性观察性研究，作为关于依度沙班在日本静脉血栓栓塞症（VTE）患者中的安全性和有效性的上市后研究的一部分进行。本文呈现了在1年时收集的数据的最终分析结果。本研究共纳入1732例患者。对1702例患者（安全性分析集；SAS）和1698例患者（有效性分析集）进行了安全性和有效性评估。在SAS中，39.4%的患者年龄≥75岁，58.2%的患者体重≤60kg，22.2%的患者肌酐清除率<50mL/min。约90%的患者接受了包装说明书推荐的剂量。共有46.1%的患者持续治疗1年，平均治疗期和中位治疗期分别为235.8天和263.0天。出血不良事件（AE）的发生率为10.3%；大出血为2.6%；VTE复发率为1.8%。与出血AE和VTE复发常见相关的危险因素是癌症。依度沙班在接受适当低剂量（30mg/天）的患者中的安全性和有效性概况，通常用于高出血风险患者，与适当标准剂量（60mg/天）的患者相似。在治疗1年时，对于依度沙班在日本VTE患者中的安全性和有效性没有重大担忧。
