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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

2019-07-10 10:53 2546
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治疗儿童疾病的研究结果。
  • 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[1]
  • 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[2]

德国殷格翰2019年7月10日 /美通社/ -- 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 Bruckmann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]-[4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]

参考文献

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[2] Brandao L. et al. Safety of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Paediatric Patient. Abstract number: OC 57.1. Special Issue: Abstracts of the XXVII Congress of the International Society on Thrombosis and Haemostasis. 2019;03(S1):138-139.
[3] Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51. 
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[6] Connolly SJ. et al. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013;128:237–43.
[7] Ezekowitz MD. et al. Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation. Europace. 2016;18:973–8.
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[11] Pollack CV. et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015;373:511–20.
[12] Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thomb Haemost. 2007;5:2178–85.
[13] RE-MOBILIZE Writing Committee. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty. 2009;24:1–9.
[14] Eriksson BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
[15] Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011;105:721–9.
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[21] Ferro. JM. et al. Randomized evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT). Presented on Tuesday 10 May at the 2nd European Stroke Organisation Conference 2016, Barcelona, Spain.
[22] Ageno W. et al. RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate. Thromb Haemost. 2017;117:415–21.
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消息来源:勃林格殷格翰
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