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阿哌沙班的安全性和有效性:2013 年我们处于何种地位?

The safety and efficacy of apixaban : where do we stand in 2013?

机构信息

Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.

出版信息

Expert Opin Drug Saf. 2013 Jul;12(4):559-67. doi: 10.1517/14740338.2013.799663. Epub 2013 May 10.

Abstract

INTRODUCTION

Traditional oral anticoagulants, such as warfarin, are effective but require frequent laboratory monitoring for dose adjustment and have several known interactions with food and other drugs. Oral direct factor Xa inhibitors are an emerging class of anticoagulants that do not require routine laboratory monitoring. We reviewed the pharmacokinetics and pharmacology as well as the clinical safety and efficacy of apixaban , an oral direct factor Xa inhibitor.

AREAS COVERED

Data from Phase II and III clinical trials and secondary analysis involving apixaban were included. Studies using apixaban for stroke prevention in patients with atrial fibrillation, for the prevention and treatment of venous thromboembolism, and for secondary prevention of ischemic events in patients with acute coronary syndromes are discussed.

EXPERT OPINION

Apixaban is a safe, effective, and attractive alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. It is also a good option for the prevention of venous thromboembolic events after major orthopedic surgery and for the extended treatment of deep vein thrombosis and pulmonary embolism. Apixaban at a dose of 5 mg twice daily did not have a favorable risk/benefit profile for secondary prevention in high-risk patients with acute coronary syndromes.

摘要

简介

传统口服抗凝剂,如华法林,疗效确切,但需要频繁进行实验室监测以调整剂量,并且与食物和其他药物存在多种已知的相互作用。口服直接 Xa 因子抑制剂是一类新兴的抗凝剂,不需要常规的实验室监测。我们综述了口服直接 Xa 因子抑制剂阿哌沙班的药代动力学和药理学特性,以及临床安全性和疗效。

涵盖领域

纳入了涉及阿哌沙班的 II 期和 III 期临床试验及二级分析的数据。讨论了阿哌沙班在预防非瓣膜性心房颤动患者卒中、预防和治疗静脉血栓栓塞症,以及用于急性冠状动脉综合征患者二级预防缺血事件的应用。

专家意见

阿哌沙班是一种安全、有效且有吸引力的华法林替代药物,可用于预防非瓣膜性心房颤动患者卒中。对于骨科大手术后静脉血栓栓塞事件的预防,以及深静脉血栓和肺栓塞的延长治疗,阿哌沙班也是一种较好的选择。对于高危急性冠状动脉综合征患者,每日两次、每次 5 毫克的阿哌沙班用于二级预防的风险/获益比不理想。

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