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.

• Authors: Mashio Nakamura, Norikazu Yamada, Tomohiko Asamura, Kazuhito Shiosakai, Kazuhiro Uchino
• Journal: Circulation reports (Circ Rep) Vol. 2 Issue 3 Pg. 192-202 (Feb 06 2020) ISSN: 2434-0790 [Electronic] Japan
• PMID: 33693227 (Publication Type: Journal Article)
• Copyright: Copyright © 2020, THE JAPANESE CIRCULATION SOCIETY.