Preview

Научно-практическая ревматология

Расширенный поиск

Новые оральные антикоагулянты в терапии антифосфолипидного синдрома

https://doi.org/10.14412/1995-4484-2016-219-226

Полный текст:

Аннотация

Основным препаратом из группы антикоагулянтов, применяемым для лечения антифосфолипидного синдрома (АФС), является антагонист витамина К варфарин. Однако у него имеется ряд недостатков, в особенности для пациентов, которым требуется длительная, а зачастую и пожизненная профилактика тромбозов. В последнее время были синтезированы новые пероральные антикоагулянты, такие как дабигатрана этексилат (Pradaxa®), ривароксабан (Xarelto®), апиксабан (Eliquis) и др. В отличие от варфарина, они применяются в фиксированных дозах, не требуют рутинного мониторинга, соблюдения диеты, взаимодействуют лишь с небольшим количеством препаратов. Новые пероральные антикоагулянты одобрены для применения по нескольким показаниям, но данные проведенных исследований не применимы для пациентов с АФС. Ожидается, что применение этих препаратов позволит улучшить качество жизни пациентов с АФС. 

Об авторах

М. А. Сатыбалдыева
ФГБНУ Научно- исследовательский институт ревматологии им. В.А. Насоновой, Москва
Россия

115522 Москва, Каширское шоссе, 34А



Т. М. Решетняк
ФГБНУ Научно- исследовательский институт ревматологии им. В.А. Насоновой, Москва
Россия

115522 Москва, Каширское шоссе, 34А



Список литературы

1. Насонов ЕЛ, редактор. Антифосфолипидный синдром. Москва: Литтерра; 2004. 424 с. [Nasonov EL, editor. Antifosfolipidnyi sindrom [Antifosfolipid syndrome]. Moscow: Litterra; 2004. 424 p.].

2. Решетняк ТМ. Антифосфолипидный синдром: диагноз и принципы терапии. Сonsilium medicum. 2002;(4):408-15 [Reshetnyak TM. Antiphospholipid syndrome: diagnosis and treatment principles. Сonsilium Medicum. 2002;(4):408-15 (In Russ.)].

3. Решетняк ТМ. Антифосфолипидный синдром: диагностика и клинические проявления (лекция). Научно-практическая ревматология. 2014;52(1):56–71 [Reshetnyak TM. Antiphospholipid syndrome: diagnosis and clinical manifestations (A Lecture). Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2014;52(1):56-71 (In Russ.)]. doi: 10.14412/1995-4484-2014-56-71

4. Erkan D, Pierangeli SS, editors. Antiphospholipid syndrome: insights and highlights from the 13th International Congress on Antiphospholipid Antibodies. New York: Springer Science+Business Media; 2012. doi: 10.1007/978-1-4614-3194-7_17

5. Asherson RA, Cervera R, Piette J-Ch, Shoenfeld Y, editors. The antiphospholipid syndrome II: Autoimmune thrombosis. New York: Elsevier; 2002. P. 3-445.

6. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306. doi: 10.1111/j.1538-7836.2006.01753.x

7. Levine J, Branch DW, Rauch J. The antiphospholipid syndrome. N Engl J Med. 2002;346:752-63. doi: 10.1056/NEJMra002974

8. Алекберова ЗС, Решетняк ТМ, Раденска СГ и др. Васкулопа- тия у больных системной красной волчанкой с антифосфоли- пидным синдромом. Терапевтический архив. 1995;(5):41-4 [Alekberova ZS, Reshetnyak TM, Radenska SG, et al. Vasculopathy in patients with systemic lupus erythematosus with antiphospholipid syndrome. Terapevticheskii Arkhiv. 1995;(5):41-4 (In Russ.)].

9. Lie JT. Pathology of the antiphospholipid syndrome. In: Asherson RA, Cervera R, Piette JC, Shoenfeld Y, eds. The antiphos￾pholipid syndrome. Boca Raton, Fl.: CRC Press; 1996. P. 89-104.

10. Austin S, Cohen H. Antiphospholipid syndrome. Medicine. 2009;34:472-5. doi: 10.1053/j.mpmed.2006.08.012

11. Середавкина НВ, Решетняк ТМ. IX Европейский форум по антифосфолипидным антителам. Краткий обзор. Научно-пра- ктическая ревматология. 2014;52(1):115-21 [Seredavkina NV, Reshetnyak TM. The IX European forum on antiphospholipid antibodies. A brief review. Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2014;52(1):115-21 (In Russ.)]. doi: 10.14412/1995-4484-2014-115-121

12. 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(2 Suppl):e419S-94S. doi: 10.1378/chest.11-2301 PMID: 22315268

13. Keeling D, Baglin T, Tait C, et al. British Committee for Standards in Haematology (BCSH) – Guidelines for General Haematology, Haemostasis and Thrombosis. Guidelines on oral anticoagulation with warfarin fourth edition. Br J Haematol. 2011;154:311-24. doi: 10.1111/j.1365-2141.2011.08753.x. Epub 2011 Jun 14. PMID: 21671894

14. Ruiz-Irastorza G, Crowther M, Branch W, Khamashta M. Antiphospholipid syndrome. Lancet. 2010;376:1498-509. doi: 10.1016/S0140-6736(10)60709-X. Epub 2010 Sep 6. PMID: 20822807

15. Arachchillage DJ, Cohen H. Use of new oral anticoagulants in antiphospholipid syndrome. Curr Rheumatol Rep. 2013 Jun;15(6):331. doi: 10.1007/s11926-013-0331-5. PMID: 23649961

16. Boehringer Ingelheim International GmBH, 21/09/2012. Available from: www.emc.medicines.org.uk

17. Xarelto 10 mg film-coated tablets. Summary of product characteristics (SPC), EU. Bayer HealthCare AG. Date of first authorisation/ renewal of authorisation: 30/09/08. Date of revision 12/2011. Available from: www.emc.medicines.org.uk

18. Eriksson BI, Quinlan DJ, Eikelboom JW. Novel oral factor Xa and thrombin inhibitors in the management of thromboembolism. Annu Rev Med. 2011;62:41-57. doi: 10.1146/annurev-med- 062209-095159. PMID: 21226611

19. Frost C, Yu Z, Nepal S, et al. Apixaban, an oral direct, factor Xa inhibitor: multiple ascending-dose safety, pharmacokinetics and pharmacodynamics in healthy subjects. J Thromb Haemost. 2007;5 Suppl 2:P-M-664.

20. Lopes RD, Alexander JH, Al-Khatib SM, et al. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J. 2010;159:331-9. doi: 10.1016/j.ahj.2009.07.035. PMID: 20211292

21. Patel M; for the ROCKET AF Study Investigators. Rivaroxaban – Once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159:340-7. doi: 10.1016/j.ahj.2009.11.025

22. Lee CJ, Ansell JE. Direct thrombin inhibitors. Br J Clin Pharmacol. 2011 Oct;72(4):581-92. doi: 10.1111/j.1365- 2125.2011.03916.x. PMID:21241354

23. Gomez-Outes A, Terleira-Fernandez AI, Calvo-Rojas G, et al. Dabigatran, rivaroxaban, orapixaban versus warfarin in patients with nonvalvular atrial fibrillation: a systemic review and meta￾analysis of subgroups. Thrombosis. 2013;2013:640723. doi: 10.1155/2013/640723. Epub 2013 Dec 22. PMID: 24455237

24. Connolly SJ, Ezekowitz MD, Yusuf S, et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. PMID: 19717844

25. Olsson SB; Executive Steering Committee of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor Ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomized controlled trial. Lancet. 2003 Nov 22;362(9397):1691-8. PMID:14643116

26. Albers GW, Diener HC, Frison L, et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA. 2005 Feb 9;293(6):690-8. PMID: 15701910

27. Fawole A, Daw HA, Crowther MA. Practical management of bleeding due to the anticoagulants dabigatran, rivaroxaban, and apixaban. Cleve Clin J Med. 2013 Jul;80(7):443-51. doi: 10.3949/ccjm.80a.13025. PMID: 23821689

28. Erikkson BI, Dahl OE, Rosencher N, et al; RE-MODEL Study Group. Oral dabigatranetexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the Re-MODEL randomized trial. J Thromb Haemost. 2007;5:2178-85. doi: 10.1111/j.1538-7836.2007.02748.x

29. Schulman S, Kakkar AK, Goldhaber SZ, et al; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONA￾HA.113.004450. Epub 2013 Dec 16. PMID: 24344086

30. NICE technology appraisal guidance 249. Dabigatranetexilate for the prevention of stroke and systemic embolism in atrial fibrilla￾tion.March 2012. Available from: www.nice.org.uk/TA249

31. Approval Drugs by FDA. Available from. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs

32. Guidance in development. Pulmonary embolism (acute treatment, VTE prevention) – rivaroxaban [ID569]. Available from: www.nice.org.uk

33. Danowski A, de Azevedo MN, de Souza Papi JA, et al. Determinants of risk for venous and arterial thrombosis in primary antiphospholipid syndrome and in antiphospholipid syndrome with systemic lupus erythematosus. J Rheumatol. 2009 Jun;36(6):1195-9. doi: 10.3899/jrheum.081194. Epub 2009 May 15. PMID: 19447935

34. Erkan D, Yazici Y, Peterson MG, et al. A cross-sectional study of clinical thrombotic risk factors and preventive treatments in antiphospholipid syndrome.Rheumatology (Oxford). 2002 Aug;41(8):924-9. PMID: 12154210

35. Ruffatti A, Del Ross T, Ciprian M, et al. Risk factors for a first thrombotic event in antiphospholipid antibody carriers. A multicentre, retrospective follow-up study. Ann Rheum Dis. 2009 Mar;68(3):397-9. doi: 10.1136/ard.2008.096669. Epub 2008 Sep 23. PMID: 18812393

36. Gage BF. Can we rely on Re-LY? N Engl J Med. 2009 Sep 17;361(12):1200-2. doi: 10.1056/NEJMe0906886. Epub 2009 Aug 30. PMID: 19717843

37. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010 Nov 4;363(19):1875- 6. doi: 10.1056/NEJMc1007378. PMID: 21047252

38. Turpie AG, Lassen MR, Davidson BL, et al; RECORD 4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee replacement (RECORD 4): a randomised trial. Lancet. 2009;373:1673-80. doi: 10.1016/S0140- 6736(09)60734-0. Epub 2009 May 4. PMID: 19411100

39. Patel MR, Mahaffey KW, Gar J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (and supplementary appendix). N Engl J Med. 2011;365:883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10. PMID: 21830957

40. NICE technology appraisal guidance 256. Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. May 2012. Available from: www.nice.org.uk/TA256

41. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism (and supplementary appendix). N Engl J Med. 2010;363:2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3. PMID: 21128814

42. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27. PMID: 21870978

43. Eliquis 2.5 mg film-coated tablets film-coated tablets Summary of Product Characteristics (SPC) last updated on the eMC: 03/12/2012. Available from: www.emc.medicines.org.uk

44. Guidance in development. Stroke and systemic embolism (prevention, non-valvular atrial fibrillation) – apixaban [ID500]. Available from: www.nice.org.uk

45. Reference ID: 3212129. Available from: www.accessdata.fda.gov/ scripts/cder/drugsatfda

46. NICE technology appraisal guidance 261. Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism. July 2012. Available from: www.nice.org.uk/TA 261

47. Guidance in development. Dabigatranetexilate for the treatment of acute venous thromboembolic events (ID108). Available from: www.nice.org.uk

48. Xarelto 20 mg film-coated tablets. Summary of product characteristics (SPC), EU. Bayer Health Care AG. Last updated on the eMC: 04/ 12/2012. Available from: www.emc.medicines.org.uk

49. EINSTEIN-PE Investigators, Bü ller HR, Prins MH, Lensin AW, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26. PMID: 22449293

50. Lassen MR, Raskob GE, Gallus A, et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009;36(6):594-604. doi: 10.1056/NEJMoa0810773. PMID: 19657123

51. Lassen MR, Raskob GE, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5. PMID: 20206776

52. Lassen MR, Gallus A, Raskob GE, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement (ADVANCE-3). N Engl J Med. 2010;363(26):2487-98. doi: 10.1056/NEJMoa1006885. PMID: 21175312

53. NICE technology appraisal guidance 245.Venous thromboembolism – apixaban (hip and knee surgery). January 2012. Available from: www.nice.org.uk/TA 245

54. Schulman S, Kearon C, Kakkar, et al; for the Re-COVER Study Group. Dabigatran versus warfarin for the treatment of acute venous thromboembolism. N Engl Med. 2009;361:2341-52. doi: 10.1056/NEJMoa0906598. PMID: 19966341

55. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368:699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8. PMID: 23216615

56. Development status of rivaroxaban, apixabanedoxaban and dabigatran. Available from: www.clinicaltrials.gov

57. Fareed J, Thethi I, Hoppensteadt D. Old versus new oral anticoagulants: focus on pharmacology. Ann Rev Pharmacol Toxicol. 2012;52:79-99. doi: 10.1146/annurev-pharmtox-010611-134633. Epub 2011 Aug 5. PMID: 21819239

58. Pengo V, Crippa L, Falanga A, et al. Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results. J Thromb Haemost. 2012;10(10):1979- 87. doi: 10.1111/j.1538-7836.2012.04866.x. PMID: 22827490

59. Buller HR. Once-daily oral rivaroxaban versus placebo in the longterm prevention of recurrent symptomatic venous thromboembolism, the Einstein-Extension Study. Late Breaking Abstracts LBA-2. 51st ASH Annual Meeting and Exposition; 2009.

60. Harder S. Renal profiles of anticoagulants. J Clin Pharmacol. 2012;52(7):964-75. doi: 10.1177/0091270011409231. Epub 2011 May 24. PMID: 21610202

61. Cohen H, Machin SJ. Antithrombotic treatment failures in antiphospholipid syndrome: the new anticoagulants? Lupus. 2010;19:486-91. doi: 10.1177/0961203310361355. PMID: 20353992

62. Baglin T, Keeling D, Kitchen S. Effects on routine coagulation screens and assessment of anticoagulant intensity in patients taking oral dabigatran or rivaroxaban: Guidence from British Committee for Standards in Haematology. Br J Haematol. 2012;159(4):427-9. doi: 10.1111/bjh.12052. PMID: 22970737

63. Ryn J, Stangier J, Haertter S, et al. Dabigatranetexilate – a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010 Jun;103(6):1116-27. doi: 10.1160/TH09-11-0758. Epub 2010 Mar 29. PMID: 20352166

64. Pradaxa®. Summary of Product Characteristics, 2011. Boehringer Ingelheim.

65. Liesenfeld KH, Schafer HG, Troconiz IF, et al. Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis. Br J Clin Pharmacol. 2006 Nov;62(5):527-37. doi: 10.1111/j.1365- 2125.2006.02667.x. PMID: 17061960

66. Van Ryn J, Baruch L, Clemens A. Interpretation of point-of-care INR results in patients treated with dabigatran. Am J Med. 2012 Apr;125(4):417-20. doi: 10.1016/j.amjmed.2011.10.017. Epub 2012 Feb 3. PMID: 22306274

67. Agarwal MB, Verma S, Mahapatra M, et al. Balancing efficacy and bleeding risk in the prevention of stroke due to atrial fibrillation with newer oral anticoagulants. Indian J Hematol Blood Transfus. 2012 Sep;28(3):129-43. doi: 10.1007/s12288-012-0167- 6. Epub 2012 Jul 28. PMID: 23997448

68. Antovic JP, Skeppholm M, Eintrei J, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol. 2013 Nov;69(11):1875-81. doi: 10.1007/s00228-013-1550-4. Epub 2013 Jun 20. PMID: 23784008

69. Stangier J, Feuring M. Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis. 2012 Mar;23(2):138-43. doi: 0.1097/MBC.0b013e32834f1b0c. PMID: 22227958

70. Martinuzzo ME, Barrera LH, D’Adamo MA, et al. Frequent false-positive results of lupus anticoagulant tests in plasmas of patients receiving the new oral anticoagulants and enoxaparin. Int J Lab Hematol. 2014;36(2):144-50. doi: 10.1111/ijlh.12138. Epub 2013 Sep 6. PMID: 24034808

71. Makris M, Joost J, van Veen JJ, et al. Guideline on the management of bleeding in patients on antithrombotic agents. Br J Haem. 2012;160:35-46. doi: 10.1111/bjh.12107. Epub 2012 Nov 1. PMID: 23116425

72. Turpie AGG, Kreutz R, Llau J, et al. Management consensus guidance for the use of rivaroxaban – an oral, direct factor Xa inhibitor. Thromb Haemost. 2012;108:876-86. doi: 10.1160/TH12- 03-0209. Epub 2012 Sep 26. PMID: 23014816

73. Spyropoulos ACD, Douketis JD. How I treat anticoagulated patients undergoing an elective procedure or surgery. Blood. 2012;120(15):2954-62. doi: 10.1182/blood-2012-06-415943. Epub 2012 Aug 28. PMID: 22932800

74. Schulman S, Crowther MA. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood. 2012;119(13):3016-23. doi: 10.1182/blood-2011-10- 378950. Epub 2012 Feb 1. PMID: 22302737

75. Llau JV, Ferrandis R. New anticoagulants and regional anesthesia. Curr Opin Anaesthesiol. 2009;22:661-6. doi: 10.1097/ACO.0b013e32832eb8ab. PMID: 19568169


Рецензия

Для цитирования:


Сатыбалдыева М.А., Решетняк Т.М. Новые оральные антикоагулянты в терапии антифосфолипидного синдрома. Научно-практическая ревматология. 2016;54(2):219-226. https://doi.org/10.14412/1995-4484-2016-219-226

For citation:


Satybaldyeva M.A., Reshetnyak T.M. NEW ORAL ANTICOAGULANTS IN THE THERAPY OF ANTIPHOSPHOLIPID SYNDROME. Rheumatology Science and Practice. 2016;54(2):219-226. (In Russ.) https://doi.org/10.14412/1995-4484-2016-219-226

Просмотров: 2711


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)