An evidence-based review of edoxaban and its role in stroke prevention in patients with nonvalvular atrial fibrillation.

Core Evidence Pub Date : 2015-05-28 eCollection Date: 2015-01-01 DOI:10.2147/CE.S61441
Tushar Acharya, Prakash Deedwania
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Abstract

Atrial fibrillation is the most common arrhythmia in the elderly. It is responsible for significant morbidity and mortality from cardioembolic complications like stroke. As a result, atrial fibrillation patients are risk-stratified using the CHADS2 or CHA2DS2-VASc scoring systems. Those at intermediate-to-high risk have traditionally been treated with therapeutic anticoagulation with warfarin for stroke prevention. Although effective, warfarin use is fraught with multiple concerns, such as a narrow therapeutic window, drug-drug and drug-food interactions, and excessive bleeding. Novel oral anticoagulant agents have recently become available as viable alternatives for warfarin therapy. Direct thrombin inhibitor dabigatran and factor Xa inhibitors like rivaroxaban and apixaban have already been approved by the US Food and Drug Administration (FDA) for stroke prevention in patients with nonvalvular atrial fibrillation. Edoxaban is the latest oral direct factor Xa inhibitor studied in the largest novel oral anticoagulant trial so far: ENGAGE AF-TIMI 48. Treatment with a 30 mg or 60 mg daily dose of edoxaban was found to be noninferior to dose-adjusted warfarin in reducing the rate of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with a lower incidence of bleeding complications and cardiovascular deaths. Edoxaban was recently reviewed by an FDA advisory committee and recommended as a stroke-prophylaxis agent. Once approved, it promises to provide another useful alternative to warfarin therapy.

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埃多沙班及其在预防非瓣膜性心房颤动患者中风中的作用的循证综述。
心房颤动是老年人最常见的心律失常。心房颤动会导致中风等心血管栓塞并发症的发病率和死亡率。因此,人们使用 CHADS2 或 CHA2DS2-VASc 评分系统对心房颤动患者进行风险分级。传统上,中高风险患者会使用华法林进行治疗性抗凝,以预防中风。华法林虽然有效,但存在多种问题,如治疗窗狭窄、药物间和药物与食物间相互作用以及出血过多。新型口服抗凝剂最近已成为华法林治疗的可行替代品。直接凝血酶抑制剂达比加群和 Xa 因子抑制剂(如利伐沙班和阿哌沙班)已被美国食品药品管理局(FDA)批准用于非瓣膜性心房颤动患者的中风预防。埃多沙班是迄今为止最大的新型口服抗凝剂试验中研究的最新口服直接 Xa 因子抑制剂:参与AF-TIMI 48。研究发现,在降低非瓣膜性心房颤动患者的中风和全身性栓塞发生率方面,每日服用 30 毫克或 60 毫克剂量的埃多沙班并不优于剂量调整后的华法林,而且出血并发症和心血管死亡的发生率较低。埃多沙班最近通过了美国食品及药物管理局咨询委员会的审查,并被推荐为中风预防药物。一旦获得批准,它有望为华法林疗法提供另一种有用的替代疗法。
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Core Evidence
Core Evidence PHARMACOLOGY & PHARMACY-
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期刊介绍: Core Evidence evaluates the evidence underlying the potential place in therapy of drugs throughout their development lifecycle from preclinical to postlaunch. The focus of each review is to evaluate the case for a new drug or class in outcome terms in specific indications and patient groups The emerging evidence on new drugs is reviewed at key stages of development and evaluated against unmet needs
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