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Current Clinical Trials on the Use of Direct Oral Anticoagulants in the Pediatric Population

机译:在儿科人群中使用直接口服抗凝剂的最新临床试验

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Common treatment options for deep vein thrombosis and venous thromboembolism in the pediatric population include unfractionated heparin, low molecular weight heparin, and warfarin. Other alternatives are bivalirudin, argatroban, and fondaparinux. Warfarin is the only approved oral option, but an oral agent without frequent monitoring would be optimal for pediatric patients. Thus, there is an increasing need for new anticoagulation options in this population. None of the current direct oral anticoagulants have FDA-approved indications and dosing in children. The two classes of DOACs and the drugs they are comprised of are factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) and direct thrombin inhibitor (dabigatran). Off-label usage of these agents is largely based on adult doses. By far, rivaroxaban and dabigatran have the most published data and ongoing trials in pediatric patients compared to edoxaban and apixaban. After evaluating the current literature available on these agents, it is, however, still too early to make any definitive recommendations on their usage in this special population.
机译:小儿深静脉血栓形成和静脉血栓栓塞的常见治疗选择包括普通肝素,低分子量肝素和华法林。其他替代品是比伐卢定,阿加曲班和磺达肝癸钠。华法林是唯一获准使用的口服药物,但对于儿童患者而言,不需经常监测的口服药物是最佳选择。因此,在该人群中对新的抗凝选择的需求增加。当前没有直接的口服抗凝剂在儿童中具有FDA批准的适应症和剂量。 DOAC的两类及其组成的药物是Xa因子抑制剂(利伐沙班,阿哌沙班,依多沙班)和直接凝血酶抑制剂(达比加群)。这些药物的标签外使用主要基于成人剂量。到目前为止,与依多沙班和阿哌沙班相比,利伐沙班和达比加群在儿科患者中具有最公开的数据和正在进行的试验。在评估了有关这些药物的现有文献之后,现在就在特殊人群中使用它们做出任何明确的建议还为时过早。

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