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[依度沙班用于心房颤动的卒中预防及静脉血栓栓塞的治疗:专家立场文件]

[Edoxaban for stroke prevention in atrial fibrillation and treatment of venous thromboembolism: an expert position paper].

作者信息

Weiss Thomas W, Rohla Miklos, Dieplinger Benjamin, Domanovits Hans, Fries Dietmar, Vosko Milan R, Gary Thomas, Ay Cihan

机构信息

3. Medizinische Abteilung, Kardiologie und internistische Intensivmedizin, Wilhelminenspital, Montleartstraße 37, 1160 Wien, Österreich.

Medizinische Fakultät, Sigmund Freud Universität, Wien, Österreich.

出版信息

Wien Med Wochenschr. 2018 Apr;168(5-6):133-143. doi: 10.1007/s10354-017-0548-4. Epub 2017 Feb 24.

Abstract

Edoxaban is the most recent available representative of the Non-Vitamin K antagonist oral anticoagulants (NOAC). The approval was based on the largest phase III trials of NOACs for stroke prevention in patients with non-valvular atrial fibrillation (AF, ENGAGE-AF), and for the treatment of venous thromboembolism (VTE, HOKUSAI-VTE). In both trials, edoxaban was associated with similar efficacy and a significant reduction in bleeding events with respect to the pre-defined primary safety endpoints, as compared to warfarin.Additionally, the once daily dosing of edoxaban, the clinically investigated strategy for dose-reduction based on clearly defined criteria and the favorable pharmacokinetic profile might further support the clinical applicability of the substance.In the light of recent data, this expert consensus document aims to summarize the latest clinical trial results while providing a concise overview of current guideline recommendations on the management of patients with non-valvular AF and VTE.

摘要

依度沙班是最新可用的非维生素K拮抗剂口服抗凝药(NOAC)代表药物。其获批基于非维生素K拮抗剂用于非瓣膜性心房颤动(AF,ENGAGE-AF试验)患者预防中风以及治疗静脉血栓栓塞(VTE,HOKUSAI-VTE试验)的规模最大的III期试验。在这两项试验中,与华法林相比,依度沙班在预定义的主要安全性终点方面具有相似的疗效且出血事件显著减少。此外,依度沙班每日一次给药、基于明确标准进行临床研究的剂量降低策略以及良好的药代动力学特征可能会进一步支持该药物的临床应用。鉴于最新数据,本专家共识文件旨在总结最新临床试验结果,同时简要概述当前关于非瓣膜性AF和VTE患者管理的指南建议。

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