ВОЗМОЖНОСТИ ДАБИГАТРАНА ЭТЕКСИЛАТА В ЛЕЧЕНИИ ВЕНОЗНЫХ ТРОМБОЭМБОЛИЧЕСКИХ ОСЛОЖНЕНИЙ
https://doi.org/10.21518/2307-1109-2015-2-17-31
Аннотация
В данной статье обсуждаются возможности использования нового перорального антикоагулянта — дабигатрана этексилата — для лечения венозных тромбо-эмболических осложнений (ВТЭО). Представлены результаты 4 рандомизированных клинических исследований — RE-COVER, RE-COVER II, RE-MEDY и RE-SONATE. В RE-COVER и RE-COVER II сравнили эффективность и безопасность дабигатрана и варфарина у больных с острым эпизодом ВТЭО, а в REMEDY и RE-SONATE оценили целесообразность продления терапии дабигатра-ном у больных ВТЭО, завершивших основной 3—6-месячный курс лечения антикоагулянтами. При этом в RE-MEDY дабигатран сравнили с варфарином, а в RE-SONATE — с плацебо. По итогам RE-COVER, RE-COVER II и RE-MEDY эффективность дабигатрана (150 мг 2 раза в день) в отношении предупреждения рецидивирующих и фатальных эпизодов ВТЭО не уступала таковой варфарина, а по влиянию на риск геморрагических осложнений дабигатран оказался более безопасным. В исследовании RE-SONATE по сравнению с плацебо дабигатран снижал риск рецидива ВТЭО на 92%, но увеличивал при этом риск больших или клинически значимых малых кровотечений в 2,9 раза.
Об авторах
Н. М. ВОРОБЬЕВА
Russian Cardiology Research and Production Complex FGBU of the Ministry of Health of the Russian Federation, Moscow
Россия
д.м.н.
Россия
д.м.н.
Е. П. ПАНЧЕНКО
Russian Cardiology Research and Production Complex FGBU of the Ministry of Health of the Russian Federation, Moscow
Россия
д.м.н., профессор
Россия
д.м.н., профессор
Список литературы
1. Oger E. Incidence of venous thromboembolism: a community-based study in Western France. Thromb Haemost, 2000. 83: 657-660.
2. Spencer FA, Emery C, Lessard D et al. The Worcester Venous Thromboembolism study: a population-based study of the clinical epidemiology of venous thromboembolism.J Gen Intern Med, 2006. 21: 722-727.
3. Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. AmJ Hematol, 2011. 86: 217-220.
4. Kearon C, Akl EA, Comerota AJ et al. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest, 2012. 141 (Suppl): e419S-e494S.
5. Российские клинические рекомендации по диагностике, лечению и профилактике венозных тром-боэмболических осложнений. Флебология, 2010. 4(1): 4-37.
6. Ansell J, Hirsh J, Hylek E et al. Pharmacology and man-
7. agement of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest, 2008. 133 (Suppl): 160S-198S.
8. Baetz BE, Spinler SA. Dabigatran etexilate: an oral direct thrombin inhibitor for prophylaxis and treatment of thromboembolic diseases. Pharmacotherapy, 2008.28: 1354-1373.
9. Eriksson BI, Dahl OE, Rosencher N et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.J ThrombHaemost, 2007. 5: 2178-2185.
10. Eriksson BI, Dahl OE, Rosencher N 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: 949-956.
11. Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N EnglJMed, 2009. 361: 1139-1151.
12. Graham DJ, Reichman ME, Wernecke M et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated with Dabigatran or Warfarin for Non-Valvular Atrial Fibrillation. Circulation, published online October 30, 2014. DOI: 10.1161/CIRCULATIONAHA. 114.012061.
13. Schulman S, Kearon C, Kakkar AK et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N EnglJMed, 2009. 361: 2342-2352.
14. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.J Thromb Haemost, 2005. 3: 692-694.
15. Schulman S, Kakkar AK, Goldhaber SZ et al. Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis. Circulation, 2014. 129: 764-772.
16. Walenga JM, Adiguzel C. Drug and dietary interactions of the new and emerging oral anticoagulants. Int JClinPract, 2010. 64: 956-967.
17. Gross PL, Weitz JI. New antithrombotic drugs. Clin Pharmacol Пег, 2009. 86: 139-146.
18. Rose AJ, Ozonoff A, Henault LE, Hylek EM. Warfarin for atrial fibrillation in community-based practice.J Thromb Haemost, 2008. 6: 1647-1654.
19. Fiessinger JN, Huisman MV, Davidson BL et al. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized trial. JAMA, 2005. 293: 681-689.
20. Schulman S, Wahlander K, Lundstrom T et al. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. NEnglJMed, 2003. 349: 1713-1721.
21. Ezekowitz MD, Reilly PA, Nehmiz G et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). AmJCardiol, 2007. 100: 1419-1426.
22. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. NEnglJMed, 2010.363:2499-2510.
23. The EINSTEIN-PE Investigators. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. NEnglJMed, 2012. 366: 1287-1297.
24. Agnelli G, Buller HR, Cohen A et al. AMPLIFY Investigators. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. NEnglJMed, 2013. 369: 799-808.
25. Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. NEnglJMed, 2013. 369: 1406-1415.
26. Schafer AI. Venous thrombosis as a chronic disease. N EnglJMed, 1999. 340: 955-956.
27. Prandoni P, Lensing AW, Cogo A et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med, 1996. 125: 1-7.
28. Agnelli G, Prandoni P, Santamaria MG et al. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. NEnglJMed, 2001.345: 165-169.
29. Agnelli G, Prandoni P, Becattini C et al. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med, 2003. 139: 19-25.
30. Kearon C, Gent M, Hirsh J et al. A comparison of three months of anticoagulation with extended anti-coagulation for a first episode of idiopathic venous thromboembolism. NEnglJMed, 1999. 340: 901-907.
31. Schulman S, Kearon C, Kakkar AK et al. for the REMEDY and the RE-SONATE Trails Investigators. Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism. NEnglJMed, 2013. 368: 709-718.
32. Agnelli G, Buller HR, Cohen A et al. for the AMPLIFY-EXT Investigators. Apixaban for Extended Treatment of Venous Thromboembolism. NEnglJMed, 2013. 368: 699-708.
Рецензия
Для цитирования:
ВОРОБЬЕВА Н.М., ПАНЧЕНКО Е.П. ВОЗМОЖНОСТИ ДАБИГАТРАНА ЭТЕКСИЛАТА В ЛЕЧЕНИИ ВЕНОЗНЫХ ТРОМБОЭМБОЛИЧЕСКИХ ОСЛОЖНЕНИЙ. Атеротромбоз. 2015;(2):17-31. https://doi.org/10.21518/2307-1109-2015-2-17-31
For citation:
Vorobieva N.M., Panchenko E.P. DABIGATRAN ETEXILATE FOR THE TREATMENT OF VENOUS THROMBOEMBOLIC COMPLICATIONS. Aterotromboz = Atherothrombosis. 2015;(2):17-31. (In Russ.) https://doi.org/10.21518/2307-1109-2015-2-17-31
Просмотров: 4575
Контент доступен под лицензией Creative Commons Attribution Attribution-NonCommercial-NoDerivs License.
Послать статью по эл. почте 