PRACTICAL ASPECTS OF APIXABAN USE IN CLINICAL PRACTICE: VIEW POINT OF CLINICAL PHARMACOLOGIST
https://doi.org/10.20996/1819-6446-2015-11-2-209-216
Abstract
Apixaban is a "new" oral anticoagulant, direct Xa factor inhibitor with a good evidence base of the efficacy in the prevention of ischemic stroke in patients with atrial fibrillation. The article is devoted to apixaban use in clinical practice: examination before apixaban administration, clinical situation when laboratory control and monitoring are needed, drugs interactions (at the level of CYP3A4, P-gp), management of patients with bleeding because of apixaban therapy (including antidotes application), perioperative management of patients receiving apixaban.
About the Authors
D. A. Sychev
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
I. I. Sinitsina
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
G. Yu. Zakharova
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
M. I. Savel'eva
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
A. V. Ryabova
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
A. V. Kryukov
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
A. Yu. Yurovskii
Russian Medical Academy of Postgraduate Education
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
Russian Federation
Barricadnaya ul. 2/1, Moscow, 123995 Russia
References
1. Tretyakov AY, Vydrina ND, Sychev DA, et al. Effect of polymorphisms of genes CYP2C9 and VKORC1 on anticoagulant effect and the maintenance dose phenindione in patients with atrial fibrillation (pilot study). Klinicheskaya Farmakologiya i Terapiya 2012; (2): 26-9. Russian (Третьяков А.Ю., Выдрина Н.Д., Сычев Д.А., и др. Влияние полиморфизмов генов CYP2C9 и VKORC1 на антикоагулянтный эффект и поддерживающую дозу фениндиона у пациентов с фибрилляцией предсердий (ре-зультаты пилотного исследования). Клиническая Фармакология и Терапия 2012; (2): 26-9).
2. Gavrisyuk EV, Ignatiev IV, Sychev DA, et al. Analysis of the application of indirect anticoagulant warfarin in patients with persistent atrial fibrillation in outpatient conditions. Klinicheskaya Farmakologiya i Terapiya 2012; (1): 42-6. Russian (Гаврисюк Е.В., Игнатьев И.В., Сычев Д.А., и др. Анализ применения непрямого антикоагулянта варфарина у пациентов с постоянной формой фибрилляции предсердий в поликлинических условиях. Клиническая Фармакология и Терапия 2012; (1):42-6).
3. Lukyanov MM, Boytsov SA, Jakushin SS, et al. Diagnosis treatment, concomitant cardiovascular disease and comorbidities in patients with a diagnosis of "atrial fibrillation" in clinical practice (according to Register Cardiovascular Disease - REKVAZA). Ration Pharmacother Cardiol 2014; 10 (4): 366-77. Russian (Лукьянов М.М., Бойцов С.А., Якушин С.С., и др. Диагностика лечение, сочетанная сер-дечно-сосудистая патология и сопутствующие заболевания у больных с диагнозом «фибрилляция предсердий» в условиях реальной клинической практики (по данным Регистра КардиВАскулярных Заболеваний РЕКВАЗА). Рациональная Фармакотерапия в Кардиологии 2014; 10 (4): 366-77).
4. Petrov VI, Shatalova OV, Maslakov AS. Analysis of antithrombotic therapy in patients with persistent atrial fibrillation (pharmacoepidemiological study). Ration Pharmacother Cardiol 2014; 10 (2): 174-8. Russian (Петров В.И., Шаталова О.В., Маслаков А.С. Анализ антитромботической терапии у боль-ных с постоянной формой фибрилляции предсердий (фармакоэпидемиологическое исследо-вание). Рациональная Фармакотерапия в Кардиологии 2014; 10 (2): 174-8).
5. Khruslov MV, Lobachyov VI, Ukhanova IY. Effectiveness of centralized monitoring of the international normalized ratio in the treatment of warfarin. Tromboz, Gemostaz i Reologiya 2014; 57 (1): 36-40. Russian (Хруслов М.В., Лобачев В.И., Уханова И.Ю. Эффективность централизованного мони-торинга международного нормализованного отношения при лечении варфарином. Тромбоз, Ге-мостаз и Реология 2014; 57(1): 36-40).
6. Serdechnaya EV, Chumak EL. Prevention of thromboembolism in patients with atrial fibrillation: Russian and international recommendations and their implementation in clinical practice. Lechashchiy Vrach 2013; 5: 80-3. Russian (Сердечная Е.В., Чумак Е.Л. Профилактика тромбоэмболических ослож-нений у пациентов с фибрилляцией предсердий: международные и российские рекомендации и их реализация в реальной клинической практике. Лечащий Врач 2013;5: 80-3).
7. Kropacheva ES, Panchenko EP, Ataullahanova DM. Comparison of the efficacy and safety of long-term therapy with warfarin and acenocoumarol in patients with atrial fibrillation. Klinicheskaya Meditsina 2005; 83 (1): 24-7. Russian (Кропачева Е.С., Панченко Е.П., Атауллаханова Д.М. Сравнение эф-фективности и безопасности длительной терапии варфарином и аценокумаролом у больных с мерцательной аритмией. Клиническая Медицина 2005; 83(1): 24-7).
8. Kukes IV, Sychev DA. Analysis of frequency and structure of adverse reactions from oral anticoagulants, recorded by spontaneous reporting in Russia. J Basic and Clinical Pharmacology 2011; 109 (Suppl 1); 76.
9. Goluhova EZ, Arslanbekova SM, Sychev DA, Kuznetsova EV. Features in warfarin dosing polifarmakoterapii patient after implantation of artificial heart valves. Kreativnaya Kardiologiya 2013; (1): 58-65. Russian (Голухова Е.З., Арсланбекова С.М., Сычев Д.А., Кузнецова Е.В. Особенности дозирования вар-фарина в условиях полифармакотерапии у пациентов после имплантации искусственных кла-панов сердца. Креативная Кардиология 2013; (1): 58-65).
10. Sulimov VA, Napalkov DA, Sokolova AA. Comparative efficacy and safety of new oral anticoagulants. Ration Pharmacother Cardiol 2013; 9 (4): 433- 8. Russian (Сулимов В.А., Напалков Д.А., Соко-лова А.А. Сравнительная эффективность и безопасность новых пероральных антикоагулянтов. Рациональная Фармакотерапия в Кардиологии 2013; 9 (4): 433- 8).
11. Gong IY, Kim RB. Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban. Can J Cardiol 2013;29(7 Suppl):S24-33.
12. 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.
13. Ward C, Conner G, Donnan G, et al. Practical management of patients on apixaban: a consensus guide. Thromb J 2013;11(1):27.
14. Camm AJ, Lip GY, Caterina R, et al., ESC Committee for Practice Guidelines (CPG): 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012; 33:2719-2747.
15. Hohnloser SH, Hijazi Z, Thomas L, et al. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J 2012, 33:2821-30.
16. ELIQUIS®(Apixaban) Approved Product Information. Bristol-Myers Squibb Australia Pty Ltd and Pfizer Pty Ltd; 2013. Available at: http://www.bmsa.com.au/products/pages/Home.aspx. Accessed by 30.03.2015.
17. Douxfils J, Chatelain C, Chatelain B, et al. Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide. Thromb Haemost 2013; 110(2):283-94.
18. Becker RC, Yang H, Barrett Y, et al. Chromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban — an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011; 32:183-7.
19. Upreti VV, Song Y, Wang J, et al. Effect of famotidine on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor. Clin Pharmacol: Advances and Applications 2013; 5:59-66.
20. Granger CB, Alexander JH, McMurray JJ, et al. ARISTOTLE Committees and Investigators: apixaban versus warfarin in patients with atrial fibrillation. New Engl J Med 2011; 365:981-92.
21. Granger CB, Alexander JH, Hanna M, et al., for the ARISTOTLE investigators: Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial [abstract]. Eur Heart J 2012; 33(Abstract Supplement): 685-6.
22. Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013; 19(4):446-51.
23. Laulicht B, Bakhru S, Lee C, et al. Small molecule antidote for anticoagulants [abstract]. Circulation 2012; 126:A11395.
24. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011; 124:1573-9.
25. Escolar G, Arellano-Rodrigo E, Reverter JC, et al. Reversal of apixaban induced alterations of hemostasis by different coagulation factor concentrates: studies in vitro with circulating human blood [abstract]. Circulation 2012; 126:520-1.
26. Martin AC, Le Bonniec B, Fischer AM, et al. Evaluation of recombinant activated factor VII, prothrombin complex concentrate, and fibrinogen concentrate to reverse apixaban in a rabbit model of bleeding and thrombosis. Int J Cardiol 2013; 168:4228-33.
27. Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol 2012; 87(Suppl 1):S141-S145.
28. Bauer KA. Reversal of antithrombotic agents. Am J Hematol 2012; 87(Suppl 1):S119-S126.
29. Fukuda T, Honda Y, Kamisato C, et al. Reversal of anticoagulant effects of edoxaban, an oral, direct factor Xa inhibitor, with haemostatic agents. Thromb Haemost 2012; 107:253-29.
30. Marlu R, Hodaj E, Paris A, et al. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban. Thromb Haemost 2012; 108:217-24.
31. Frost C, Nepal S, Wang J, et al. Apixaban, an oral, direct factor Xa inhibitor: single-dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol 2013; 75(2):476-87.
32. Ferrandis R, Castillo J, de Andrés J, et al. The perioperative management of new direct oral anticoagulants: a question without answers. Thromb Haemost 2013; 110:515-22.
33. Baron TH, Kamath PS, McBane RD. Antithrombotic therapy and invasive procedures. New Engl J Med 2013; 368:1079-80.
34. Douketis JD. Pharmacologic properties of the new oral anticoagulants: a clinician-oriented review with a focus on perioperative management. Curr Pharm Des 2010; 16:3436-41.
Review
For citations:
Sychev D.A., Sinitsina I.I., Zakharova G.Yu., Savel'eva M.I., Ryabova A.V., Kryukov A.V., Yurovskii A.Yu. PRACTICAL ASPECTS OF APIXABAN USE IN CLINICAL PRACTICE: VIEW POINT OF CLINICAL PHARMACOLOGIST. Rational Pharmacotherapy in Cardiology. 2015;11(2):209-216. (In Russ.) https://doi.org/10.20996/1819-6446-2015-11-2-209-216
Views:
822
Email this article 