德國殷格翰2019年7月10日 /美通社/ -- 勃林格殷格翰公司在澳大利亞墨爾本舉行的2019年國際血栓與止血學會（ISTH）年會上，對外公布了兩項使用達比加群治療兒童疾病的研究結果。[1],[2]
研究數據顯示，在治療兒童急性靜脈血栓栓塞（VTE）時，達比加群與目前的標準療法（SOC）擁有相似的療效與安全性。[1]另一項研究同樣證實了達比加群良好的安全性，這項研究首次評估了采用直接口服抗凝劑（DOAC）在存在持續性VTE風險因素的兒童中預防復發性VTE的效果。[2]
目前，用于治療與預防兒童復發性VTE的標準療法存在一定的局限性，包括需要頻繁監測與非口服給藥等。[2]上述針對達比加群的全新研究旨在為對VTE患兒及存在VTE復發風險的兒童采用抗凝治療提供更多的洞見與專業知識。
勃林格殷格翰公司副總裁、心血管代謝領域臨床開發負責人Martina Bruckmann教授說：“多年來，VTE的診斷率與發病率都在急劇上升，兒童VTE的發病率很高。盡管目前我們擁有治療VTE的相關療法，但兒童患者仍需獲得有效、安全與更加便捷的治療選擇。因此，我們旨在研究達比加群在成人VTE患者中被證實的安全性與療效是否同樣適用于兒童患者。令人鼓舞的是，這些研究表明達比加群在兒童復發性VTE的潛在治療與預防上具有相似的安全性與療效。”
達比加群（泰畢全，Pradaxa）尚未在任何國家獲批用于治療VTE患兒。上述研究反映了勃林格殷格翰公司始終致力于拓展血栓疾病治療領域的科學知識。廣泛的RE-VOLUTION®臨床試驗項目已充分證實達比加群在成人患者中的安全性與療效，并擁有大量臨床試驗數據。[3]-[4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]
參考文獻
[1] Albisetti M. et al. Efficacy and Safety of Dabigatran Etexilate for Treatment of Venous Thromboembolism in Paediatric Patients - Results of the DIVERSITY Trial. Abstract number: OC 57.3. Special Issue: Abstracts of the XXVII Congress of the International Society on Thrombosis and Haemostasis. 2019;03(S1):139-140.
[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.
[4] Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-76.
[5] Connolly SJ. et al. Additional Events in the RE-LY Trial. N Engl J Med. 2014;371:1464–5.
[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.
[8] Cannon CP. et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017;377:1513–24.
[9] Calkins H. et al. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017;376:1627–36.
[10] Pollack CV. et al. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017;377:431–41.
[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.
[16] Schulman S. et al. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
[17] Schulman S. et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129:764–72.
[18] Schulman S. et al. Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
[19] Eikelboom JW. et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206–14.
[20] Diener HC. et al. Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS). Int J Stroke. 2015;10:1309–12.
[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.
[23] Huisman MV. et al. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017;69:777–85.
[24] Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.
Am Heart J.2014;167:329–34.
[25] RE-VECTO Surveillance Program: Evaluating the use of idarucizumab in a real-world setting. Available at: https://www.re-vecto.com/
