Preview

Современная ревматология

Расширенный поиск

Фебуксостат в терапии подагры: от теории к практике

https://doi.org/10.14412/1996-7012-2017-4-83-88

Аннотация

Подагра – хроническое заболевание, требующее назначения постоянной урат-снижающей терапии. «Золотым стандартом» такой терапии является аллопуринол. В течение последнего десятилетия был синтезирован и появился в арсенале врачей новый препарат – фебуксостат, селективный ингибитор ксантиноксидазы. В статье проведен обзор литературы, посвященной основным клиническим исследованиям этого препарата, в которых была показана его эффективность, сопоставимая или превышающая эффективность аллопуринола, а также продемонстрировано возможное назначение его пациентам со сниженной функцией почек, с аллергической реакцией на аллопуринол или же с резистентностью к терапии аллопуринолом, что значительно улучшает прогноз у таких пациентов. При длительном приеме фебуксостата наблюдалось практически полное рассасывание тофусов и прекращение рецидивирования атак подагрического артрита. Все эти факты делают фебуксостат перспективным и необходимым препаратом для лечения подагры.

 

Об авторах

Е. В. Ильиных
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», Москва
Россия


С. А. Владимиров
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», Москва
Россия


М. С. Елисеев
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», Москва
Россия


Литература

1. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017 Jan;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. Epub 2016 Jul 25.

2. Елисеев МС. Подагра. В кн.: Ревматология. Российские клинические рекомендации. Москва: Гэотар МЕДИА; 2017.

3. С. 253-64. [Eliseev MS. Gout. In: Revmatologiya. Rossiiskie klinicheskie rekomendatsii [Rheumatology. Russian clinical recommendations]. Moscow: Geotar MEDIA; 2017. P. 253-64.]

4. Okamoto K, Eger BT, Nishino T, et al. An extremely potent inhibitor of xanthinoxidoreductase. J Biol Chem. 2003 Jan 17;278(3): 1848-55. Epub 2002 Nov 5.

5. Елисеев МС. Лечение подагры: что важно помнить, чтобы избежать ошибок. Доктор.ру. 2013;(2):63-9. [Eliseev MS. Gout treatment: what is important to remember to avoid errors. Doktor.ru. 2013;(2):63-9.

6. (In Russ.)].

7. EMA (European Medicines Agency). http://wwwemea.europa.eu/humandocs/Hu mans/EPAR/adenuric/adenuric.htm

8. Love BL, Barrons R, Veverka A, Snider KM. Urate-lowering therapy for gout: Focus on febuxostat. Pharmacotherapy. 2010 Jun;30(6): 594-608. doi: 10.1592/phco.30.6.594.

9. Zhao L, Takano Y, Horiuchi H. Effect of febuxostat, a novel non-purine, selective inhibitor of xantine oxidase (NP-SIXO), on enzymes in purine and pyrimidine methabolism pathway. Arthritis Rheum. 2003;48 Suppl 9:S531.

10. Khosravan R, Grabowski BA, Wu JT, et al. Pharmacokinetics, pharmacodynamics and safety of febuxostat, a non-purine selective inhibitor of xantine oxidase, in dose escalation study in healthy subjects. Clin Pharmacokinet. 2006;45(8):821-41.

11. Mukoyoshi M, Nishimura S, Hoshide S, et al. In vitro drug-drug interaction studies with febuxostat, a novel non-purine selective inhibitor of xanthine oxidase: plasma protein binding, identification of metabolic enzymes and cytochrome P450 inhibition. Xenobiotica. 2008 May;38(5):496-510. doi: 10.1080/00498 250801956350.

12. Bruce SP. Febuxostat: a selective xanthine oxidase inhibitor for the treatment of hyper-uricemia and gout. Ann Pharmacother. 2006 Dec;40(12):2187-94. Epub 2006 Nov 28.

13. Grabowski B.A., Khosravan R., Vernillet L., et al. Metabolism and excretion of [14C] febuxostat, a novel non-purine selective inhibitor of xantine oxidase, in healthy male subjects. J Clin Pharmacol. 2011 Feb;51(2):189-201. doi: 10.1177/ 0091270010365549. Epub 2010 Mar 30.

14. Komoriya K, Hoshide S, Takeda K, et al. Pharmacokinetics and pharmacodynamics and safety of febuxostat (TMX-67), a non-purine selective inhibitor of xantine oxidase/ xantine dehydrogenase (NPSIXO) in patientsbwith gout and/or hyperuricemia. Nucleosides Nucleotides Nucleic Acids.

15. Oct;23(8-9):1119-22.

16. Swan S, Khosravan R, Mauer MD, et al. Effect of renal impairment on pharmacokinetics, pharmacodynamics, and safety of febuxostat (TMX-67), a novel non-purine, selective inhibitor of xanthine oxidase. Arthritis Rheum. 2003;48(suppl 9):529.

17. Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr. 2014.107. Epub 2014 Jun 19.

18. Juge PA, Truchetet ME, Pillebout E, et al. Efficacy and safety of febuxostat in 73 gouty patients with stage 4/5 chronic kidney disease: A retrospective study of 10 centers. Joint Bone Spine. 2017 Oct;84(5):595-598. doi: 10.1016/j.jbspin.2016.09.020. Epub 2016 Nov 4.

19. Saag KG, Whelton A, Becker MA, et al. Impact of Febuxostat on Renal Function in Gout Patients With Moderate-to-Severe Renal Impairment. Arthritis Rheumatol. 2016 Aug;68(8):2035-43. doi: 10.1002/art.39654.

20. Mukoyoshi M, Nishimura S, Hoshide S, et al. In vitro drug-drug interaction studies with febuxostat, a novel non-purine selective inhibitor of xanthine oxidase: plasma protein binding, identification of metabolic enzymes and cytochrome P450 inhibition. Xenobiotica. 2008 May;38(5):496-510.

21. Grabowski BA, Khosravan R, Wu JT, et al, Pharmacokinetics, Pharmacodynamics and Safety of Febuxostat, a Non-Purine Selective Inhibitor of Xanthine Oxidase, in a Dose Escalation Study in Healthy Subjects. Clin Pharmacokinetics. 2006 Aug;45(8):821-41.

22. Grabowski BA, Khosravan R, Wu JT, et al. Effect of hydrochlorothiazide on pharmaco-kinetics and pharmacodynamics of febuxostat. Br J Clin Pharmacol. 2010 Jul;70(1):57-64.

23. Khosravan R, Mayer MD, Wu JT. Effect of concomitant administration of febuxostat and colchicine on pharmacokinetics of febuxostat and colchicine at steady state. Arthritis Rheum. 2005;52(suppl):102-3.

24. Khosravan R, Wu JT, Joseph-Ridge N, et al. Pharmacokinetic interactions of concomitant administration of febuxostat and NSAIDs. J Clin Pharmacol. 2006 Aug;46(8):855-66.

25. Becker MA, Schumacher HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyper-uricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61.

26. Schumacher HR, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8.

27. doi: 10.1002/art.24209.

28. Seegmiller JE. Xantine stone formation. Am J Med. 1968 Nov;45(5):780-3.

29. Wortmann RL, Becker MA, Schumacher HR, et al. Effect of febuxostat or allopurinol on the clinical manifestations of gout: reduction in gout flares and tophus size over time in the EXCEL trial. ACR/ARHP Annual Scientific Meeting; 2006.

30. Becker MA, Schumacher HR, Espinoza L, et al. A phase III randomized, controlled, multicenter, double-blind trial comparing efficacy and safety of daily febuxo-stat and allopurinol in subjects with gout. The Meeting of the American College of Rheumatology. San Francisco; 2008.

31. Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.

32. Schumacher HR, Wortmann R, Becker M, et al. Long-term safety and efficacy of febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, in subjects with hyperuricemia and gout. Ann Rheum Dis 2005 Jul; 64 Suppl. 3:498.

33. Becker MA, Schumacher Jr HR, Wortmann RL, et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005 Mar; 52(3):916-23.

34. Schumacher HR, Becker MA, Wortmann RL, et al. The FOCUS trial 48-month interim analysis: long-term clinical outcomes of treatment with febuxostat in subjects with gout in an ongoing phase 2, open-label extension study [abstract no. OP0130]. Ann Rheum Dis 2006 Jul; 65 Suppl. II: 93

35. White W, Chohan S, Dabholkar A, et al. Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Am Heart J. 2012 Jul;164(1):14-20. doi: 10.1016/j.ahj.2012. 04.011. Epub 2012 Jun 13.

36. MacDonald T, Ford I, Nuki G, et al. Protocol of the febuxostat versus allopurinol streamlined trial (FAST): a large prospective, randomized open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia. BMJ Open. 2014 Jul 10;4(7):e005354. doi: 10.1136/ bmjopen-2014-005354.

37. Abeles AM. Advances in Urate-Lowering Therapy: Time to Revisit High-Dose Febuxostat. Am J Ther. 2017 May;24(3):e241-e242. doi: 10.1097/MJT.0000000000000565.

38. Yamamoto T, Hidaka Y, Inaba M, et al. Effects of febuxostat on serum urate level in Japanese hyperu- ricemia patients. Mod Rheumatol. 2015 Sep;25(5):779-83. doi: 10.3109/14397595.2015.1016257. Epub 2015 Jun 12.

39. Mizuno T, Hayashi T, Hikosaka S, et al. Efficacy and safety of febuxostat in elderly female patients. Clin Interv Aging. 2014 Sep 4;9:1489-93. doi: 10.2147/CIA.S70855. eCollection 2014.

40. Dalbeth N, Jones G, Terkeltaub R, et al. Lesinurad, a novel selective uric acid reabsorption inhibitor, in combination with febuxostat, in patients with tophaceous gout. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4.

41. Saag KG, Fitz-Patrick D, Kopicko J, et al. Lesinurad combined with allopurinol: a randomized, double-blind, placebo-controlled study in gout patients with an inadequate response to standard-of-care allopurinol (a US-based study). Arthritis Rheumatol. 2017 Jan;69(1):203-212. doi: 10.1002/art.39840.

42. Meng J, Li Y, Yuan X, Lu Y. Effects of febuxostat on insulin resistance and expression of high-sensitivity C-reactive protein in patients with primary gout. Rheumatol Int. 2017 Feb;37(2):299-303. doi: 10.1007/s00296-016-3612-2. Epub 2016 Nov 23.

43. Елисеев МС, Шаяхметова РУ. Опыт применения фебуксостата у пациента с тяжелой инвалидизирующей подагрой. Современная ревматология. 2017;11(3):81-4. [Eliseev MS, Shayakhmetova RU. Experience with febuxostat in a patient with severe disabling gout. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2017;11(3): 81-4. (In Russ.)]. doi: 10.14412/1996-7012-2017-3-81-84


Рецензия

Просмотров: 13160


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


ISSN 1996-7012 (Print)
ISSN 2310-158X (Online)