达比加群治疗儿童静脉血栓栓塞的安全性与疗效得以证实

  • 首批评估达比加群治疗与预防儿童复发性静脉血栓栓塞（VTE）的研究
  • IIb / III期DIVERSITY研究显示达比加群治疗急性VTE患儿的疗效与安全性与标准疗法相当
  • 另一项III期研究进一步证实达比加群在存在持续性VTE风险因素的儿童中预防复发性VTE的安全性

      德国殷格翰，2019年7月10日——勃林格殷格翰公司在澳大利亚墨尔本举行的2019年国际血栓与止血学会（ISTH）年会上，对外公布了两项使用达比加群酯治疗儿童疾病的研究结果。1,2

      研究数据显示，在治疗儿童急性静脉血栓栓塞（VTE）时，达比加群与目前的标准疗法（SOC）拥有相似的疗效与安全性。1另一项研究同样证实了达比加群良好的安全性，这项研究首次评估了采用直接口服抗凝剂（DOAC）在存在持续性VTE风险因素的儿童中预防复发性VTE的效果。2

      目前，用于治疗与预防儿童复发性VTE的标准疗法存在一定的局限性，包括需要频繁监测与非口服给药等。2上述针对达比加群的全新研究旨在为对VTE患儿及存在VTE复发风险的儿童采用抗凝治疗提供更多的洞见与专业知识。

      勃林格殷格翰公司副总裁、心血管代谢领域临床开发负责人Martina Brückmann教授说：“多年来，VTE的诊断率与发病率都在急剧上升，儿童VTE的发病率很高。尽管目前我们拥有治疗VTE的相关疗法，但儿童患者仍需获得有效、安全与更加便捷的治疗选择。因此，我们旨在研究达比加群在成人VTE患者中被证实的安全性与疗效是否同样适用于儿童患者。令人鼓舞的是，这些研究表明达比加群在儿童复发性VTE的潜在治疗与预防上具有相似的安全性与疗效。”

      达比加群（泰毕全, Pradaxa）尚未在任何国家获批用于治疗VTE患儿。上述研究反映了勃林格殷格翰公司始终致力于拓展血栓疾病治疗领域的科学知识。广泛的RE-VOLUTION®临床试验项目已充分证实达比加群在成人患者中的安全性与疗效，并拥有大量临床试验数据。3-25

 

关于DIVERSITY研究（Ablisetti M等）

      这项开放标签、随机、多中心、IIb / III期试验评估对比达比加群和标准疗法（低分子量肝素或维生素K拮抗剂）治疗出生至18岁以下、需要抗凝治疗的急性VTE患儿的疗效与安全性，治疗期为3个月。1

      复合疗效终点是出现VTE复发、VTE相关死亡以及血栓溶解的患儿比例。次要终点包括安全性（出血事件）以及药物代谢动力学/药效学关系。1

      DIVERSITY试验结果表明，与标准疗法相比，达比加群在治疗VTE高风险患儿时疗效不劣于标准疗法，出血发生率相似。1

 

关于二级VTE预防研究（Brandao L等）

      这项开放标签、单臂、前瞻性队列、III期试验是首个针对直接口服抗凝剂对儿童VTE二级预防效果的研究。在本研究中，大约200名儿童接受了达比加群治疗，治疗期长达12个月。本研究的主要终点包括VTE复发、出血事件以及6个月与12个月的死亡率。2

      研究结果显示，VTE复发与大出血事件的总体发生率较低。2基于这些结果，作者得出结论：这项试验显示与标准疗法相比，达比加群针对罹患VTE或具有持续血栓风险的儿童拥有“良好的安全性结果”。2

 

参考文献

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