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非维生素K拮抗剂口服抗凝剂的安全性——冠状动脉风险

Safety of non-vitamin K antagonist oral anticoagulants - coronary risks.

作者信息

Caldeira Daniel, Ferreira Joaquim J, Pinto Fausto J, Costa João

机构信息

a Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina , Universidade de Lisboa , Lisbon , Portugal.

b Clinical Pharmacology Unit , Instituto de Medicina Molecular , Lisbon , Portugal.

出版信息

Expert Opin Drug Saf. 2016 Jun;15(6):731-40. doi: 10.1517/14740338.2016.1164689. Epub 2016 Apr 12.

Abstract

INTRODUCTION

Since the approval and commercialization of non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, and rivaroxaban) several studies and meta-analyses have raised safety concerns regarding myocardial infarction (MI) risk among NOAC-treated patients, particularly with dabigatran. Uncertainty remains regarding the coronary risk associated with dabigatran, and whether this putative risk also applies to the other NOACs.

AREAS COVERED

In this review, the coronary risks of NOACs based on findings from placebo-controlled trials are discussed, and randomized controlled trials and major cohort studies in AF patients are also appraised. We performed a random-effect meta-analysis, including both interventional trials and observational studies ("real-world" data). Further estimates were retrieved from the meta-analysis of coronary risk among NOAC-treated patients with concomitant AF and coronary disease.

EXPERT OPINION

Currently, the best available data from both clinical trials and observational studies do not support the claim that patients treated with NOACs, including dabigatran, are at increased coronary risk. However, a definitive conclusion cannot be made (especially regarding dabigatran) and further data are required to address the coronary risks, mostly of high-risk patients. As with any therapeutic intervention, the possible complications should be balanced against the potential benefits at an individual patient level.

摘要

引言

自从非维生素K拮抗剂口服抗凝剂(NOACs;阿哌沙班、达比加群、依度沙班和利伐沙班)获批并商业化以来,多项研究和荟萃分析引发了人们对接受NOAC治疗的患者发生心肌梗死(MI)风险的安全担忧,尤其是使用达比加群的患者。关于达比加群相关的冠状动脉风险以及这种假定风险是否也适用于其他NOACs,仍存在不确定性。

涵盖领域

在本综述中,我们将基于安慰剂对照试验的结果讨论NOACs的冠状动脉风险,并对房颤患者的随机对照试验和主要队列研究进行评估。我们进行了一项随机效应荟萃分析,纳入了干预性试验和观察性研究(“真实世界”数据)。进一步的估计值来自对合并房颤和冠心病的接受NOAC治疗患者的冠状动脉风险荟萃分析。

专家意见

目前,来自临床试验和观察性研究的现有最佳数据并不支持使用包括达比加群在内的NOACs治疗的患者冠状动脉风险增加这一说法。然而,尚不能得出明确结论(尤其是关于达比加群),需要更多数据来解决冠状动脉风险问题,主要是针对高危患者。与任何治疗干预一样,应在个体患者层面权衡可能的并发症与潜在益处。

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