Mishuku Hospital

Tokyo, Japan

Mishuku Hospital

Tokyo, Japan

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Fuji T.,Osaka Hospital | Wang C.-J.,Chang Gung University | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | And 6 more authors.
Thrombosis Research | Year: 2014

Introduction This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with enoxaparin sodium (enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan.Materials and methods In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or enoxaparin 2000 IU (equivalent to 20 mg) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions.Results Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and enoxaparin groups, respectively (relative risk reduction = 46.8%), indicating non-inferiority (P < 0.001) and superiority (P = 0.010) of edoxaban versus enoxaparin. In the edoxaban and enoxaparin groups, major bleeding occurred in 4/354 (1.1%) versus 1/349 (0.3%) patients (P = 0.373); major or CRNM bleeding occurred in 22/354 (6.2%) versus 13/349 (3.7%) patients (P = 0.129), respectively.Conclusions Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events. © 2014 Elsevier Ltd. All rights reserved.


Fuji T.,Osaka Hospital | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | Abe Y.,Kumamoto Chuo Hospital | And 4 more authors.
Thrombosis Journal | Year: 2015

Background: Edoxaban is an oral, direct, factor Xa inhibitor approved in Japan for thromboembolic prophylaxis after lower-limb orthopedic surgery (LLOS), but contraindicated in patients with severe renal impairment (SRI; creatinine clearance [CLCR] ≥15 to <30 mL/min). Methods: This open-label study compared the safety of edoxaban 15 mg once daily in Japanese patients with SRI to that of edoxaban 30 mg in patients with mild renal impairment (MiRI; CLCR ≥50 to ≤80 mL/min; N = 30) undergoing LLOS. Patients with CLCR ≥20 to <30 mL/min were randomized to receive edoxaban 15 mg (N = 22) or subcutaneous fondaparinux 1.5 mg once daily (N = 21). All patients with CLCR ≥15 to <20 mL/min received edoxaban 15 mg (N = 7). Treatment was administered for 11 to 14 days. Results: Major or clinically relevant non-major bleeding occurred in 6.7%, 3.4%, and 5.0% of patients in the MiRI edoxaban 30-mg, SRI edoxaban 15-mg, and SRI fondaparinux groups, respectively; there were no major bleeding events. No thromboembolic events occurred. At all time points assessed, edoxaban plasma concentrations and changes in coagulation biomarkers were similar between the SRI and MiRI groups. Conclusions: These results suggest edoxaban 15 mg once daily is well tolerated in Japanese patients with SRI undergoing LLOS. © 2015 Fuji et al.; licensee BioMed Central.


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.


Nagasawa J.,Toho University | Kiyozaka T.,Mishuku Hospital | Ikeda K.,Toho University
Journal of Stroke and Cerebrovascular Diseases | Year: 2014

Background: Pathologic findings of cerebral amyloid angiopathy (CAA) and Alzheimer disease (AD) coexist frequently. Both diseases are associated with b-Amyloid deposition and dementia. We aimed to evaluate frequency and clinicoradiological profile of AD patients with multiple microbleeds (MBs).Methods:We reviewed clinical records and magnetic resonance imaging (MRI) findings in patients with probable AD diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and National Institute of Neurological and Communicative Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) criteria from 2009 to 2012. Brain MRI was performed at 1.5-T superconducting system, including T2∗-weighted gradient-echo imaging. MBs were defined as rounded, hypointense foci less than or equal to 10 mm in size in the brain parenchyma. MBs topography was divided into the lobar (L) and the deep/infratentorial (D/I) region. Multiple MBs were defined as the number greater than or equal to 8 in the L and the D/I territory, respectively. White matter hyperintensities (WMHs) were assessed using the age-related white matter changes scale. Clinicoradiological findings were examined for 1 year. Prevalence and clinicoradiological profiles were studied in patients with multiple L or D/I MBs.Results: Five hundred fifty patients (238 men and 312 women) participated in the present study. Mean age (standard deviation) was 78.4 (7.7) years, 78.3 (8.1) years in men and 78.6 (7.5) years in women. A total of 132 patients (55 men and 78 women) had at least 1 MB. Prevalence of MB ≥ 1 was 24%, 23 in men and 25 in women. The ratio of L and D/I MBs were 1.1, .6 in men and 1.8 in women. Multiple MBs were detected in 93 patients (17%), 38 (16%) men and 55 (17%) in women. L distribution was found in 49 patients (9%), 15 men (6%) and 34 women (11%), and D/I distribution in 44 patients (8%), 23 men (10%) and 21 women (7%). Multiple L MBs was associated with faster progression of dementia, cerebral hemorrhage, and increased number of MBs. Multiple D/I MBs were linked to hypertension and WMH scores.Conclusions: The present study indicated that the prevalence of multiple MBs was 17% in Japanese AD patients. The clinicoradiological profile suggested severe degree of CAA in patients with multiple L MBs (9%) and hypertension and aged changes in patients with multiple D/I MBs (8%). T2∗-weighted imaging is a useful tool for evaluating degree of CAA and hypertensive vascular changes.We should pay more attention to management and care in AD patients with multiple MBs. © 2014 National Stroke Association.


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.


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.


Fuji T.,Osaka Koseinenkin Hospital | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | Nakamura M.,Mie University | And 4 more authors.
Thrombosis Research | Year: 2014

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 30 mg once daily (n = 62) or enoxaparin sodium (enoxaparin) 2000 IU (equivalent to 20 mg) twice daily (n = 30) for 11 to 14 days. 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 2000 IU twice daily, oral edoxaban 30 mg 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. © 2014 Elsevier Ltd. All rights reserved.


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.


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.


Nakayama S.,Mishuku Hospital | Murashima N.,Mishuku Hospital
Indian Journal of Gastroenterology | Year: 2011

Although statins are generally well-tolerated drugs, recent cases of autoimmune hepatitis (AIH) associated with their use have been reported. A 59-year-old Japanese man reported with liver damage, which appeared one month after beginning treatment with fluvastatin and continued after discontinuation of the drug. Although drug-induced liver injury was possible, positive autoantibody tests (antinuclear antibodies >1/1280, anti-mitochondrial M2 antibodies 21 index value) also suggested autoimmune liver disease. Liver biopsy findings were consistent with an overlap of autoimmune hepatitis and primary biliary cirrhosis. Treatment with prednisone and ursodeoxycholic acid led to a good response. In this patient, manifestation of AIH and primary biliary cirrhosis overlap syndrome was possibly triggered by statin use. Autoimmune liver disease should be considered as a possible diagnosis in patients with evidence of prolonged liver damage after discontinuation of statins. © 2011 Indian Society of Gastroenterology.

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