阿哌沙班与华法林在严重肾功能损害患者中的安全性和有效性比较

Brooke E. Stanton, Naomi S Barasch, K. Tellor
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引用次数: 99

摘要

美国食品和药物管理局批准阿哌沙班用于肌酐清除率(CrCl) < 15ml /分钟或接受透析的患者,仅基于药代动力学数据,因为阿哌沙班的临床试验排除了CrCl < 25ml /分钟或血清肌酐浓度(SCr)为bb0 2.5 mg/dl的患者。因此,本研究的目的是评估阿哌沙班与华法林在严重肾功能损害患者中的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment
The U.S. Food and Drug Administration approval of the use of apixaban in patients with a creatinine clearance (CrCl) of < 15 ml/minute or in those receiving dialysis is based only on pharmacokinetic data as clinical trials of apixaban excluded patients with a CrCl of < 25 ml/minute or a serum creatinine concentration (SCr) of > 2.5 mg/dl. Thus, the objective of this study was to evaluate the safety and effectiveness of apixaban versus warfarin in patients with severe renal impairment.
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