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Nishi-Tokyo-shi, Japan

Fuji T.,Japan Community Health care Organization Osaka Hospital | Wang C.-J.,Chang Gung University | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | And 2 more authors.
Journal of Arthroplasty | Year: 2014

Edoxaban, an oral direct factor Xa inhibitor, has proven antithrombotic efficacy. In a multicenter, phase II study, 264 total hip arthroplasty (THA) patients randomly received edoxaban 15 or 30 mg once daily or enoxaparin 2000. IU (20-mg) twice daily for 11-14 days. Thromboembolic event incidences were 3.8% (3/78), 2.8% (2/72), and 4.1% (3/74) for edoxaban 15-mg, 30-mg, and enoxaparin, respectively (P= 1.00). Edoxaban-induced prolongation of prothrombin time, international normalized ratio, and activated partial thromboplastin time were proportional to plasma edoxaban concentration. Major or clinically relevant non-major bleeding incidences were 2.2% (2/89), 1.2% (1/85), and 2.3% (2/87) for edoxaban 15-mg, 30-mg, and enoxaparin, respectively (P= 1.00). Once-daily edoxaban showed similar efficacy and safety to enoxaparin for prevention of thromboembolic events in patients undergoing THA. © 2014 The Authors. Source

Imai K.,Mishuku Hospital | Imai K.,University of Tokyo
Journal of Bone and Mineral Metabolism | Year: 2011

Computed tomography-based nonlinear finite element method (CT/FEM) can accurately predict vertebral compressive strength ex vivo and this method is clinically available in vivo. This study aimed to assess vertebral fracture risk and alendronate effects on osteoporosis in vivo using CT/FEM. Vertebral strength in 123 postmenopausal women was analyzed and the discriminatory power for vertebral fracture was assessed cross-sectionally. Alendronate effects were also prospectively assessed in 33 patients with postmenopausal osteoporosis who were treated with alendronate at a dose of 5 mg/day for 18 months. CT/FEM had higher discriminatory power for vertebral fracture than areal bone mineral density (BMD) and volumetric BMD and detected alendronate effects at 3 months. Marked bone density increases were noted in juxtacortical areas compared to inner trabecular areas. CT/FEM was useful for assessing vertebral fracture risk and therapeutic effects on osteoporosis. © 2011 The Japanese Society for Bone and Mineral Research and Springer. Source

Fuji T.,Japan Community Healthcare Organization Osaka Hospital | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | Nakamura M.,Mie University | And 4 more authors.
Thrombosis Journal | Year: 2015

Background: In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. Methods: This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n = 303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. Results: The incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P = 0.475). Conclusions: Oral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding. © 2015 Fuji et al. Source

Nakayama S.,Mishuku Hospital
Indian Journal of Gastroenterology | Year: 2012

A 92-year-old Japanese woman with moderate liver fibrosis, schistosomiasis and steatohepatitis-like lesion, was diagnosed with hepatocellular carcinoma (HCC) by dynamic CT and elevated serum levels of alpha-fetoprotein and des-gamma-carboxyprothrombin. During follow up, the levels of tumor markers became normal without any treatment, and dynamic CT showed disappearance of the tumor and progression of hepatic steatosis. The mechanism of this spontaneous regression of HCC is unclear although massive necrosis due to rapid tumor growth or cancer immunity may have played a role. © 2012 Indian Society of Gastroenterology. Source

Fuji T.,Osaka Koseinenkin Hospital | Fujita S.,Takarazuka Daiichi Hospital | Tachibana S.,Mishuku Hospital | Kawai Y.,Sanno Hospital
Journal of Thrombosis and Haemostasis | Year: 2010

Edoxaban (the free base of DU-176b) is an oral, direct factor (F)Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Objectives: The aim of the present study was to evaluate the efficacy and safety of edoxaban for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA). Patients/methods: This was a randomized, double-blind, placebo-controlled, multicenter study conducted in Japan. A total of 523 Japanese patients were assigned to receive edoxaban 5, 15, 30 or 60 mg once daily or placebo for 11-14 days. A placebo control was used as neither low-molecular-weight heparin (LMWH) nor fondaparinux had been approved for thromboprophylaxis at the time of the study in Japan. The primary efficacy outcome was the incidence of VTE (lower-extremity deep vein thrombosis, symptomatic pulmonary embolism or symptomatic deep vein thrombosis). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: Edoxaban produced a significant dose-related reduction in VTE: the incidence of VTE was 29.5%, 26.1%, 12.5% and 9.1% in the edoxaban 5-, 15-, 30- and 60-mg treatment groups vs. 48.3% in the placebo group. The incidence of major and clinically relevant non-major bleeding was similar across all groups without any significant differences among edoxaban doses or between edoxaban and placebo. Conclusions: Edoxaban demonstrated significant dose-dependent reductions in VTE in patients undergoing TKA with a bleeding incidence similar to placebo. [This trial is registered with JAPIC, JapicCTI-060283 (ja).] © 2010 International Society on Thrombosis and Haemostasis. Source

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