Takeshi Fuji1, Satoru Fujita2, Yohko Kawai3, Mashio Nakamura4, Tetsuya Kimura5, Yuichi Kiuchi6, Kenji Abe7, Shintaro Tachibana8. 1. Department of Orthopaedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan. Electronic address: fuji-th@umin.ac.jp. 2. Department of Orthopaedic Surgery, Takarazuka Daiichi Hospital, Takarazuka, Japan. 3. International University of Health and Welfare, Tokyo, Japan. 4. Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, Tsu, Japan. 5. Clinical Planning Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 6. New Drug Regulatory Affairs Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 7. Clinical Data & Biostatistics Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 8. Department of Orthopaedic Surgery, Mishuku Hospital, Tokyo, Japan.
Abstract
INTRODUCTION:Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery. MATERIALS AND METHODS: In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30mg once daily (n=62) or enoxaparin sodium (enoxaparin) 2000IU (equivalent to 20mg) twice daily (n=30) for 11 to 14days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. RESULTS: In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively. CONCLUSIONS: Compared to subcutaneous enoxaparin 2000IU twice daily, oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. CLINICAL TRIALS REGISTRATION NUMBER: NCT01181141.
RCT Entities:
INTRODUCTION:Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery. MATERIALS AND METHODS: In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30mg once daily (n=62) or enoxaparin sodium (enoxaparin) 2000IU (equivalent to 20mg) twice daily (n=30) for 11 to 14days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. RESULTS: In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively. CONCLUSIONS: Compared to subcutaneous enoxaparin 2000IU twice daily, oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. CLINICAL TRIALS REGISTRATION NUMBER: NCT01181141.
Authors: David R Anderson; Gian Paolo Morgano; Carole Bennett; Francesco Dentali; Charles W Francis; David A Garcia; Susan R Kahn; Maryam Rahman; Anita Rajasekhar; Frederick B Rogers; Maureen A Smythe; Kari A O Tikkinen; Adolph J Yates; Tejan Baldeh; Sara Balduzzi; Jan L Brożek; Itziar Etxeandia- Ikobaltzeta; Herman Johal; Ignacio Neumann; Wojtek Wiercioch; Juan José Yepes-Nuñez; Holger J Schünemann; Philipp Dahm Journal: Blood Adv Date: 2019-12-10
Authors: Dimitrios V Papadopoulos; Ioannis Kostas-Agnantis; Ioannis Gkiatas; Andreas G Tsantes; Panagiota Ziara; Anastasios V Korompilias Journal: Eur J Orthop Surg Traumatol Date: 2017-03-17