PDF(Pubmed)
Abstract：
Until 2010, the vitamin K antagonist warfarin was the only available oral anticoagulant for the prevention of stroke or systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (NVAF) and the treatment of venous thromboembolism (VTE) in the United States. Despite its proven efficacy, the use of warfarin is limited by numerous disadvantages, including a delayed onset of action and variable efficacy resulting from interactions with genetic and environmental factors. Consequently, optimal anticoagulation with warfarin requires dose adjustments based on frequent monitoring. In contrast to warfarin, direct oral anticoagulants (DOACs) including dabigatran, rivaroxaban, apixaban, and edoxaban have predictable pharmacokinetic profiles, few drug-drug interactions, no known interactions with food, and can be administered at fixed doses without the requirement for routine monitoring. All DOACs have received US Food and Drug Administration (FDA) approval for the prevention of stroke or SEE in patients with NVAF and the treatment of VTE based on phase 3 trials demonstrating that they are at least as efficacious as warfarin. In addition, the incidence of clinically relevant bleeding associated with DOACs is comparable to or lower than with warfarin. In this article, the preclinical and clinical data that led to the FDA approval of once-daily edoxaban in January 2015 are presented. Furthermore, practical considerations for edoxaban use including dosing recommendations, transitions of care, reversal of anticoagulation, precautions, contraindications, and cost-effectiveness are discussed. Edoxaban is an important addition to oral anticoagulation options available for the therapeutic management of patients with NVAF or VTE.
摘要：
直到2010年，在美国，维生素K拮抗剂华法林是唯一可用于预防非瓣膜性心房颤动（NVAF）患者中风或全身栓塞事件（SEE）以及静脉血栓栓塞（VTE）治疗的口服抗凝剂。尽管其功效已被证明，华法林的使用受到许多缺点的限制，包括与遗传和环境因素相互作用导致的延迟起效和可变功效。因此,华法林的最佳抗凝治疗需要在频繁监测的基础上调整剂量.与华法林相比,直接口服抗凝剂（DOAC），包括达比加群，利伐沙班,阿哌沙班,依度沙班有可预测的药代动力学特征，很少有药物-药物相互作用，没有已知的与食物的相互作用，并且可以以固定剂量给药，而无需常规监测。所有DOAC均已获得美国食品和药物管理局（FDA）批准，用于预防NVAF患者的中风或SEE以及基于3期试验的VTE治疗，证明它们至少与华法林一样有效。此外,DOAC相关的临床相关出血发生率与华法林相当或低于华法林.在这篇文章中,介绍了导致FDA于2015年1月批准每日一次依度沙班的临床前和临床数据.此外，使用edoxaban的实际考虑因素，包括给药建议，护理的过渡，抗凝逆转,预防措施,禁忌症,并讨论了成本效益。依多沙班是可用于NVAF或VTE患者治疗管理的口服抗凝药物的重要补充。
