阿哌沙班与华法林在重度肾功能损害患者中的安全性和有效性比较。
Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment.
作者信息
Stanton Brooke E, Barasch Naomi S, Tellor Katie B
机构信息
Missouri Baptist Medical Center, St. Louis, Missouri.
Department of Pharmacy Practice, St. Louis College of Pharmacy, St. Louis, Missouri.
出版信息
Pharmacotherapy. 2017 Apr;37(4):412-419. doi: 10.1002/phar.1905. Epub 2017 Mar 10.
STUDY OBJECTIVE
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.
DESIGN
Retrospective, matched-cohort study.
SETTING
Community hospital.
PATIENTS
A total of 146 adults who received at least one dose of apixaban (73 patients) or warfarin (73 patients) while hospitalized between January 30, 2014, and December 31, 2015, and had a CrCl of < 25 ml/minute or SCr of > 2.5 mg/dl, or who received peritoneal dialysis or hemodialysis, were included. Patients who were taking warfarin and had a therapeutic international normalized ratio on admission were matched consecutively in a 1:1 fashion in chronologic order to patients taking apixaban based on renal function and indication for anticoagulation.
MEASUREMENTS AND MAIN RESULTS
The primary outcome was major bleeding. Secondary outcomes included the composite of bleeding (major bleeding, clinically relevant nonmajor bleeding, and minor bleeding) in addition to documented ischemic stroke or recurrent venous thromboembolism. A nonsignificant difference in the occurrence of major bleeding and composite bleeding was observed between patients who received apixaban compared with those who received warfarin (9.6% vs 17.8%, p=0.149, and 21.9% vs 27.4%, p=0.442, respectively). The occurrence of stroke was similar between the groups (7.5% in each group), and no recurrent venous thromboembolism events were noted in either group during the study period.
CONCLUSION
Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment.
研究目的
美国食品药品监督管理局批准阿哌沙班用于肌酐清除率（CrCl）＜15 ml/分钟的患者或接受透析的患者，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＜25 ml/分钟或血清肌酐浓度（SCr）＞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重度肾功能不全患者中的安全性和有效性。
设计
回顾性配对队列研究。
地点
社区医院。
患者
共有146名成年人，他们在2014年1月30日至2015年12月31日住院期间接受了至少一剂阿哌沙班（73例患者）或华法林（73例患者），且CrCl＜25 ml/分钟或SCr＞2.5 mg/dl，或接受了腹膜透析或血液透析。入院时服用华法林且国际标准化比值处于治疗范围的患者，根据肾功能和抗凝指征，按时间顺序与服用阿哌沙班的患者以1:1的比例连续配对。
测量指标及主要结果
主要结局是大出血。次要结局包括出血（大出血、临床相关非大出血和小出血）合并记录在案的缺血性卒中或复发性静脉血栓栓塞。接受阿哌沙班的患者与接受华法林的患者相比，大出血和合并出血的发生率无显著差异（分别为9.6%对17.8%，p = 0.149；21.9%对27.4%，p = 0.442）。两组间卒中发生率相似（每组均为7.5%），且在研究期间两组均未出现复发性静脉血栓栓塞事件。
结论
对于重度肾功能不全患者，阿哌沙班似乎是华法林的合理替代药物。
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