Safety and Effectiveness of Edoxaban in Japanese Venous Thromboembolism Patients　― Final Analysis of One-Year Follow-up Data From a Japanese Postmarketing Observational Study (ETNA-VTE-Japan) ―

Abstract

Background: 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. Methods and Results: 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). Conclusions: At 1 year of treatment, there were no major concerns regarding the safety and effectiveness of edoxaban in Japanese patients with VTE.

Efficacy of edoxaban for the treatment of gynecological cancer-associated venous thromboembolism: analysis of Japanese real-world data

“…Compared with the UFH subgroup, the single-drug subgroup had more patients without PE. Nakamura et al [ 34 ] reported similar results in a prospective observational study of the use of edoxaban for the treatment of VTE in a Japanese cohort, approximately 25% of whom were patients with cancer. In that study, 44% of the patients who did not undergo initial UFH treatment did not show increased VTE recurrence.…”

A Phase II Study to Compare the Safety and Efficacy of Direct Oral Anticoagulants versus Subcutaneous Dalteparin for Cancer-Associated Venous Thromboembolism in Patients with Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY

“…It is known that Asian patients have a significantly lower cancer-associated VTE incidence than Caucasian patients [21,22]. A study in 1732 Japanese patients with VTE reported that VTE recurrence was 1.8% with edoxaban [23]. Furthermore, as this study focused on patients with currently active and metastatic cancers, the duration of follow-up could be relatively short due to clinical deterioration with disease progression and death, which could come first before recurrent CA-VTE.…”

Comparative effectiveness and safety of edoxaban, rivaroxaban, and apixaban in patients with venous thromboembolism: A cohort study

“…First, our findings are not generalizable to other ethnic groups. Japanese have a lower incidence of VTE than Europeans and Americans, 4 but a higher proportion of VTE patients at high risk of bleeding, such as the elderly and those who are underweight or have impaired renal function 45 . Second, the MDV database collects data from acute care hospitals, and our results may accordingly only partially apply to patients treated in clinics and long‐term care facilities.…”