Pros and cons of new oral anticoagulants

Pros and cons of new oral anticoagulants
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DOI:
10.1182/asheducation-2013.1.464
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发表时间:
2013-12-01
影响因子:
3
通讯作者:
Bauer, Kenneth A.
Bauer, Kenneth A.
中科院分区:
教育学4区
文献类型:
--
作者:
Bauer, Kenneth A.

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针对凝血酶(Dabigatran Etexilate)或凝血因子Xa(Rivaroxaban和apixaban)用于预防和治疗血栓形成的新型ORA抗凝剂(NOAC)的可用性一直备受期待。与维生素K拮抗剂(如华法林)相比,NOAC具有主要的药理优势,包括快速起效/抵消作用、很少药物相互作用和可预测的药代动力学,从而消除了对定期凝血监测的要求。根据临床试验的结果,监管机构已经批准了几种NOAC的特定适应症,这些药物的有效性和安全性至少与华法林(用于预防心房颤动的中风和治疗静脉血栓栓塞症和二级预防静脉血栓栓塞症)或低分子肝素(用于初始治疗髋关节或膝关节置换患者的静脉血栓栓塞症和血栓预防)一样好,如果不是更好的话。然而,由于几个因素,这种新的治疗类别在临床实践中的采用速度慢于预期,包括对没有实验室监测的服药依从性的担忧,一些患者群体对剂量的不确定性(例如,肾功能障碍,明显的极端体重),以及与华法林相比更高的药物成本。其他问题是目前缺乏针对NOAC的特定解毒剂,以及大多数中心衡量药物水平的检测方法。NOAC在市场上的适应症将扩大,至少有一种额外的药物(依多沙班)可能在未来两年内获得批准。随着从业者对药物的熟悉和医疗系统适应它们的使用,NOAC的使用量将随着时间的推移大幅增加,然而,华法林仍将是许多患者合适的抗凝剂选择。
The availability of new ora anticoagulants (NOACs) targeting either thrombin (dabigatran etexilate) or factor Xa (rivaroxaban and apixaban) for the prevention and treatment of thrombosis has been highly anticipated NOACs have major pharmacologic advantages over vitamin K antagonists (eg, warfarin), including rapid onset/offset of action, few drug interactions, and predictable pharmacokinetics, eliminating the requirement for regular coagulation monitoring. Regulatory agencies have approved several NOACs for specific indications based on the results of clinical trials demonstrating efficacy and safety that are at least as good, if not better, than warfarin (for stroke prevention in atrial fibrillation and treatment and secondary prevention of venous thromboembolism) or low-molecular-weight heparin, which is injectable (for initial treatment of venous thromboembolism and thromboprophylaxis in patients undergoing hip or knee arthroplasty). However, the adoption of this new therapeutic class into clinical practice has been slower than expected due to several factors including concerns regarding medication adherence without laboratory monitoring, uncertainty about dosing in some patient populations (eg, renal dysfunction, marked extremes of body weight), and higher drug costs compared with warfarin. Other issues are the current absence of specific antidotes for NOACs and assays to measure drug levels at most centers. The indications for NOACs on the market will expand and at least one additional agent (edoxaban) will likely gain approval within the next 2 years. As practitioners gain familiarity with the drugs and healthcare systems adapt to their use, NOAC use will increase substantially over time, Warfarin, however, will continue to be an appropriate anticoagulant choice for many patients.