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首页> 外文期刊>Polish Archives of Internal Medicine >Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications
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Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications

机译：在临床实践中与使用直接作用的口服抗凝剂相关的不良事件：出血并发症之外

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Non-vitamin K oral anticoagulants, also known as direct oral anticoagulants (DOACs), have entered the?market in 2008 with the expected breakthrough potential of circumventing limitations related to treatment?with vitamin K antagonists (eg, warfarin) by virtue of their pharmacological properties. Although data?derived from premarketing randomized clinical trials have largely demonstrated the clinical benefit of?DOACs, especially in terms of reduced risk of intracranial bleeding, it is important to monitor the safety?in the postmarketing phase, which better reflects real-world patients with comorbidities and polypharmacotherapy,?in order to assess the actual risk–benefit profile. In this critical review, we aimed to evaluate?the evidence on the latest debated safety issues. In the first section, we will discuss: 1) the need for?pharmacovigilance (ie, the science and activities relating to the detection, assessment, understanding,?and prevention of adverse effects or any other drug-related problems in the real-world setting), and 2) the?importance of properly interpreting postmarketing data to avoid unnecessary alarm. In the second section,?emerging and debated safety issues potentially associated with the use of DOACs in the postmarketing?setting will be assessed: 1) the potential coronary risk (which emerged during the preapproval period);?2) the occurrence of liver injury (a risk undetected in clinical trials and highlighted by case reports or?series); and 3) the potential for renal damage (a still unclear safety issue). It is anticipated that hepatic?and renal issues still require dedicated postauthorization safety studies to ultimately assess causality.
机译：非维生素K口服抗凝剂，也称为直接口服抗凝剂（DOAC），由于其药理作用，有望在2008年进入市场，有望突破与维生素K拮抗剂（例如华法林）治疗相关的局限性属性。尽管来自上市前随机临床试验的数据已在很大程度上证明了DOAC的临床益处，尤其是在降低颅内出血风险方面，但在上市后阶段监控安全性非常重要，因为它可以更好地反映现实世界中患有糖尿病的患者合并症和多药治疗，以评估实际的风险-收益状况。在这次重要的审查中，我们旨在评估有关最新辩论的安全问题的证据。在第一部分中，我们将讨论：1）药物警戒的必要性（即与检测，评估，了解和预防不良反应或现实世界中任何其他与药物相关的问题有关的科学和活动）设置），以及2）正确解释售后数据以避免不必要的警报的重要性。在第二部分中，将评估与上市后使用DOAC潜在相关的新兴安全性和辩论性安全问题：1）潜在的冠状动脉风险（在批准前出现）; 2）肝损伤的发生（在临床试验中未发现并通过病例报告或系列突出显示的风险）; 3）潜在的肾脏损害（尚不清楚的安全性问题）。预计肝和肾问题仍需要专门的授权后安全性研究以最终评估因果关系。

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