Department of Cardiology, Kuwana City Medical Center.
Division of Cardiovascular Surgery, Yokohama Minami Kyosai Hospital.
Circ J. 2021 Nov 25;85(12):2201-2207. doi: 10.1253/circj.CJ-20-0829. Epub 2021 May 15.
A post-marketing surveillance study (STANDARD-VTE) evaluated the real-world safety and effectiveness of apixaban in Japanese patients prescribed for either the treatment of venous thromboembolism (VTE) or prevention of recurrent VTE.
Patients newly initiated on apixaban were followed up for 52 weeks or 28 days post-discontinuation. Subgroup analysis was performed on patients with and without active cancer, and on patients with provoked VTE and with unprovoked VTE. A total of 1,119 patients were enrolled. Of these, 43.1% were aged ≥75 years, 46.4% had body weight ≤60 kg, and 21.3% had active cancer; mean serum creatinine was 0.76 mg/dL. The incidence of adverse drug reactions (ADRs) was 8.85%, and that of severe ADRs was 3.22%. Incidence of any bleeding, major bleeding, and recurrent VTE was 6.70%, 3.40%, and 0.80%, respectively. In patients starting apixaban 10 mg twice daily, THE incidence of any bleeding and major bleeding was 7.72% and 3.86%, respectively. In patients with active cancer, THE incidence of any bleeding and major bleeding was 16.81% and 9.24%, respectively.
No new safety signals of apixaban were identified in Japanese patients with VTE. In this study, the safety and effectiveness of apixaban in real-world practice was consistent with the results of the apixaban phase III trial.
一项上市后监测研究（STANDARD-VTE）评估了阿哌沙班在日本患者中的真实世界安全性和疗效，这些患者被处方用于治疗静脉血栓栓塞症（VTE）或预防 VTE 复发。
新开始接受阿哌沙班治疗的患者被随访 52 周或停药后 28 天。在有和没有活动性癌症的患者中、在有和没有诱因的 VTE 的患者中进行了亚组分析。共纳入 1119 例患者。其中，43.1%的患者年龄≥75 岁，46.4%的患者体重≤60kg，21.3%的患者有活动性癌症；平均血清肌酐为 0.76mg/dL。不良反应（ADR）的发生率为 8.85%，严重 ADR 的发生率为 3.22%。任何出血、大出血和 VTE 复发的发生率分别为 6.70%、3.40%和 0.80%。在开始每日两次服用 10mg 阿哌沙班的患者中，任何出血和大出血的发生率分别为 7.72%和 3.86%。在有活动性癌症的患者中，任何出血和大出血的发生率分别为 16.81%和 9.24%。
在日本 VTE 患者中未发现阿哌沙班的新安全性信号。在这项研究中，阿哌沙班在真实世界实践中的安全性和有效性与阿哌沙班 III 期试验的结果一致。
