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首页> 外文期刊>Circulation journal >Short-Term Safety and Plasma Concentrations of Edoxaban in Japanese Patients With Non-Valvular Atrial Fibrillation and Severe Renal Impairment
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Short-Term Safety and Plasma Concentrations of Edoxaban in Japanese Patients With Non-Valvular Atrial Fibrillation and Severe Renal Impairment

机译：非瓣膜心房颤动和严重肾损伤的日本患者的短期安全性和血浆浓度

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Background: The short-term safety and plasma concentrations of edoxaban 15 mg once daily in Japanese patients with non-valvular atrial fibrillation (NVAF) and severe renal impairment (SRI; creatinine clearance [CLCR] ≥15 to CR≥50 ml/min) treated with edoxaban 30 or 60 mg. Methods?and?Results: In this Phase 3 multicenter open-label 3 parallel-group study, SRI patients received once-daily edoxaban 15 mg (n=50), whereas normal/MiRI patients were randomized to receive either once-daily edoxaban 30 or 60 mg (n=22 and 21, respectively) for 12 weeks. Plasma edoxaban concentrations and biomarkers of blood coagulation and fibrinolysis were measured. Adverse events and thromboembolic events were recorded throughout the study. Rates of any bleeding were comparable between SRI patients receiving edoxaban 15 mg (20.0%) and normal/MiRI patients receiving edoxaban 30 or 60 mg (22.7% and 23.8%, respectively). No major bleeding or thromboembolic events occurred in any treatment group. Similar plasma concentrations and biomarker profiles were observed in SRI patients receiving edoxaban 15 mg and normal/MiRI patients receiving edoxaban 30 or 60 mg. Conclusions: In this 12-week short-term study in Japanese NVAF patients with SRI, edoxaban 15 mg once daily exhibited similar safety, plasma concentration, and biomarker profiles as did the 30-mg and 60-mg doses in patients with normal/MiRI. ( Circ J 2015; 79: 1486–1495)
机译：背景：日本非瓣膜心房颤动（NVAF）和严重肾损伤（SRI;肌酐清除[CL CR ]≥15用Edoxaban 30或60mg处理的Cr ≥50ml/ min。方法？结果：在这一相3多中心开放标签3平行群体研究中，SRI患者接受一次每日一次Edoxaban 15mg（n = 50），而正常/ MiRi患者随机接受一次每日埃希克萨巴30或分别为60mg（n = 22和21个）12周。测量血浆Edoxaban浓度和血液凝固和纤维蛋白溶解的生物标志物。在整个研究中记录了不良事件和血栓栓塞事件。在接受Edoxaban 15毫克（20.0％）和正常/ MiRI患者接受Edoxaban 30或60mg（分别为22.7％和23.8％）的正常/微米患者之间的任何出血率相当。任何治疗组都没有发生重大出血或血栓栓塞事件。在接受Edoxaban 15毫克的SRI患者中观察到类似的血浆浓度和生物标志物谱和接受Edoxaban 30或60mg的正常/ Miri患者。结论：在日本NVAF患者的12周短期研究中，Edoxaban 15毫克每日一次表现出类似的安全性，血浆浓度和生物标志物型材，如正常/美丽的患者30毫克和60毫克的剂量一样。 （2015年CIRC; 79：1486-1495）

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