Morrill Amanda M, Ge Dan, Willett Kristine C
MCPHS University, Manchester, NH, USA
MCPHS University, Manchester, NH, USA.
Ann Pharmacother. 2015 Sep;49(9):1031-45. doi: 10.1177/1060028015591846. Epub 2015 Jun 23.
To review current literature for target-specific oral anticoagulants (TSOACs) and provide critical analysis for dosing recommendations in special population groups.
A literature search was conducted in Medline (1996 to April week 2 2015) and Embase (1980 to 2015 week 16) using key terms dabigatran, rivaroxaban, apixaban, edoxaban, kidney diseases, liver diseases, elderly, obesity, and special populations.
Randomized controlled trials in English assessing efficacy and safety of TSOACs in healthy adults and special populations were selected for analysis.
Phase 3 trials for TSOACs predominately excluded patients with severe renal impairment or active liver disease. There were no exclusion criteria based on age, body weight or body mass index. Additional conclusions were made in special populations, including those with renal or liver impairment and obese and elderly patients, based on secondary analyses, pharmacokinetic, and pharmacodynamic studies.
Pharmacokinetic and pharmacodynamic changes associated special populations may alter clinical decision with regard to drug selection and dosing. It is valuable to understand the rationale for labeled dosing recommendations in nonvalvular atrial fibrillation and venous thromboembolism treatment and prevention, particularly in patients that fall into special population groups. Furthermore, the use of TSOACs is likely to increase as clinicians gain experience with these agents and additional TSOACs and indications are approved.
回顾目前关于靶向特异性口服抗凝剂（TSOACs）的文献，并对特殊人群的给药建议进行批判性分析。
在Medline（1996年至2015年第2周）和Embase（1980年至2015年第16周）中进行文献检索，使用关键词达比加群、利伐沙班、阿哌沙班、依度沙班、肾脏疾病、肝脏疾病、老年人、肥胖症和特殊人群。
选择以英文发表的评估TSOACs在健康成年人和特殊人群中疗效和安全性的随机对照试验进行分析。
TSOACs的3期试验主要排除了严重肾功能损害或活动性肝病患者。没有基于年龄、体重或体重指数的排除标准。基于二次分析、药代动力学和药效学研究，在特殊人群中得出了其他结论，包括那些有肾或肝损害的患者以及肥胖和老年患者。
与特殊人群相关的药代动力学和药效学变化可能会改变药物选择和给药方面的临床决策。了解非瓣膜性心房颤动以及静脉血栓栓塞治疗和预防中标记给药建议的基本原理很有价值，尤其是在属于特殊人群的患者中。此外，随着临床医生对这些药物的经验增加以及更多的TSOACs和适应证获得批准，TSOACs的使用可能会增加。
