Vornicu Ovidiu, Larock Anne-Sophie, Dincq Anne-Sophie, Douxfils Jonathan, Dogné Jean-Michel, Mullier François, Lessire Sarah
a Department of Anesthesiology , Université catholique de Louvain, CHU UCL Namur , Yvoir , Belgium.
b Namur Thrombosis and Hemostasis Center (NTHC) - NAmur Research Institute of LIfe Sciences (NARILIS) , Namur , Belgium.
Expert Opin Biol Ther. 2017 Oct;17(10):1275-1296. doi: 10.1080/14712598.2017.1349749. Epub 2017 Jul 20.
Idarucizumab is a specific antagonist for dabigatran etexilate (DE). The recent market authorization of idarucizumab in Europe and the USA may reassure prescribers of DE, as it can increase the safety of the emergency management of patients taking this anticoagulant. However, idarucizumab use should be limited to specific indications to avoid unnecessary risks to patients and costs to healthcare systems. Areas covered: The authors provide an overview of idarucizumab development and its pharmacokinetic and pharmacodynamic properties. The results of the clinical phase III trial RE-VERSE AD and a review of recent case reports of idarucizumab use in emergency contexts are also discussed. Expert opinion: Although idarucizumab has shown clear efficacy in reversing dabigatran-induced coagulopathy, its overall effects on patient outcome have not been proven. Information regarding the clinical context in which patients on DE are admitted for emergency treatment, and accurate laboratory tests of dabigatran plasma level during reversal may inform selection and help with the follow-up of patients who may benefit from idarucizumab. Idarucizumab should be integrated into protocol for the emergency management of patients on DE. Furthermore, the benefit of idarucizumab in specific indications such as acute ischemic stroke should be investigated.
依达赛珠单抗是达比加群酯（DE）的特异性拮抗剂。近期依达赛珠单抗在欧洲和美国获得上市许可，这可能会让DE的处方医生安心，因为它可以提高服用这种抗凝剂患者的急救安全性。然而，依达赛珠单抗的使用应限于特定适应症，以避免给患者带来不必要的风险和给医疗系统造成成本。涵盖领域：作者概述了依达赛珠单抗的研发情况及其药代动力学和药效学特性。还讨论了III期临床试验RE-VERSE AD的结果以及近期在紧急情况下使用依达赛珠单抗的病例报告综述。专家观点：尽管依达赛珠单抗在逆转达比加群引起的凝血病方面已显示出明确疗效，但其对患者预后的总体影响尚未得到证实。关于服用DE的患者因紧急治疗入院时的临床背景信息，以及逆转过程中达比加群血浆水平的准确实验室检测，可能有助于指导选择并辅助跟进可能从依达赛珠单抗中获益的患者。依达赛珠单抗应纳入DE患者的急救管理方案。此外，应研究依达赛珠单抗在急性缺血性卒中等特定适应症中的益处。
