ФЕБУКСОСТАТ ДЛЯ ЛЕЧЕНИЯ ХРОНИЧЕСКОЙ ГИПЕРУРИКЕМИИ У ПАЦИЕНТОВ, СТРАДАЮЩИХ ПОДАГРОЙ
https://doi.org/10.21518/2079-701X-2017-17-114-122
Аннотация
Фебуксостат – непуриновый, селективный ингибитор изоформ ксантиноксидоредуктазы, он является альтернативой ограниченному числу лекарственных препаратов для снижения уровня уратов, применяемых в последние десятилетия. Ингибирование ксантиноксидоредуктазы фебуксостатом более мощно и эффективно, чем аллопуринолом, что подтверждается более частым достижением целевого уровня уратов в сыворотке крови, особенно у пациентов с высокой концентрацией уратов. В отличие от аллопуринола фармакокинетические свойства фебуксостата не зависят в значительной степени от почечного клиренса, что важно для пациентов с хроническими заболеваниями почек. В нескольких исследованиях проводится дальнейшая оценка безопасности фебуксостата для сердечно-сосудистой системы и его возможного позитивного воздействия на функции почек. Важно и то, что пациентам пожилого возраста не требуется коррекция дозы препарата.
Об авторах
М. С. ПетроваРоссия
Кандидат медицинских наук
В. И. Мазуров
Россия
Академик РАН, доктор медицинских наук, профессор
О. В. Инамова
Россия
Кандидат медицинских наук
Список литературы
1. Smith EUR, Diaz-Torne C, Perez-Ruiz F et al. Epidemiology of gout: an update. Best Pract Res Clin Rheumatol, 2010, 24: 811-827.
2. Kuo CF, Grainge MJ, Zhang W et al. Global epidemiology of gout: prevalence, incidence and risk factors. Nat Rev Rheumatol, 2015 Jul 7. doi: 10.1038/nrrheum.2015.91. [Epub ahead of print].
3. Hak AE, Curhan GC, Grodstein F et al. Menopause, postmenopausal hormone use and risk of incident gout. Ann Rheum Dis, 2010, 69: 1305-1309.
4. Smith E, Hoy D, Cross M et al. The global burden of gout: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis, 2014 Aug, 73(8): 1470-1476.
5. Vos T, Barber RM, Bell B et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet, 2015 Jun 7. pii: S0140-6736(15)60692-4.
6. Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum, 2011, Oct, 63(10): 3136-3141.
7. Lawrence RC, Felson DT, Helmick CG et al, National Arthritis Data Wo Arthritis Rheum. 2008 Jan, 58(1): 26-35. Downloaded by [University of California, San Diego] at 06: 48 07 March 2016.
8. Kuo CF, Grainge MJ, Mallen C et al. Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study. Ann Rheum Dis, 2015 Apr, 74(4): 661-667.
9. Mikuls TR, Farrar JT, Bilker WB et al. Gout epidemiology: results from the UK General Practice Research Database, 1990-1999. Ann Rheum Dis, 2005 Feb, 64(2): 267-272.
10. Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother, 2011 Oct, 9(5): 271-285.
11. Winnard D, Wright C, Taylor WJ et al. National prevalence of gout derived from administrative health data in Aotearoa New Zealand. Rheumatology, 2012, 51: 901-909.
12. Doherty M, Jansen TL, Nuki G et al. Gout: why is this curable disease so seldom cured? Ann Rheum Dis, 2012 Nov, 71(11): 1765-1770.
13. Singh JA, Hodges JS, Toscano JP et al. Quality of care for gout in the US needs improvement. Arthritis Rheum, 2007, 57: 822-829.
14. Perez-Ruiz F, Dalbeth N, Bardin T. A review of uric acid, crystal deposition disease, and gout. Adv Ther, 2015 Jan, 32(1): 31-41.
15. Edwards NL, Sundy JS, Forsythe A et al. Work productivity loss due to flares in patients with chronic gout refractory to conventional therapy. J Med Econ, 2011, 14(1): 10-15.
16. Richette P, Doherty M, Pascual E et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Annals of the Rheumatic Diseases, 2017, 76: 29-42.
17. Richette P, Perez-Ruiz F, Doherty M et al. Improving cardiovascular and renal outcomes in gout: what should we target? Nat Rev Rheumatol, 2014 Nov, 10(11): 654-661.
18. Rees F, Hui M, Doherty M. Optimizing current treatment of gout. Nat Rev Rheumatol, 2014 May, 10(5): 271-283.
19. Zhang W, Doherty М, Bardin Т et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee For International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis, 2006 Oct, 65(10): 1312-1324.
20. Khanna D, Khanna PP, Fitzgerald JD et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken), 2012 Oct, 64(10): 1447-1461.
21. Richette P, Bardin T. Gout. Lancet, 2010 Jan 23, 375(9711): 318-328.
22. Beara-Lasic L, Pillinger MH, Goldfarb DS. Advances in the management of gout: critical appraisal of febuxostat in the control of hyperuricemia. Int J Nephrol Renovasc Dis, 2010, 3: 1-10.
23. Seth R, Kydd AS, Buchbinder R et al. Allopurinol for chronic gout. Cochrane Database Syst Rev, 2014 Oct 14, 10: CD006077.
24. Kydd AS, Seth R, Buchbinder R et al. Uricosuric medications for chronic gout. Cochrane Database Syst Rev, 2014 Nov 14, 11: CD010457.
25. Castrejon I, Toledano E, Rosario MP et al. Safety of allopurinol compared with other uratelowering drugs in patients with gout: a systematic review and meta-analysis. Rheumatol Int, 2015 Jul, 35(7): 1127-1137.
26. Diaz-Torné C, Perez-Herrero N, Perez-Ruiz F. New medications in development for the treatment of hyperuricemia of gout. Curr Opin Rheumatol, 2015 Mar, 27(2): 164-169.
27. Perez-Ruiz F, Dalbeth N, Schlesinger N. Febuxostat, a novel drug for the treatment of hyperuricemia of gout. Future Rheumatol, 2008, 10, 3(5): 421-427.
28. Okamoto K, Eger BT, Nishino T et al. An extremely potent inhibitor of xanthine oxidoreductase. J Biol Chem, 2003, 278: 1848-1855.
29. The vision of Febuxostat. Teijin Pharma Limited. Project stories Vol. 01. Japan, 2013. Available at: http: //www.teijin-pharma.com/project/story01.html [Last accessed 23 August 2015].
30. Adenuric. European Medicines Agency. Human medicines. Authorisation details. United Kingdom, 2015. [Last accessed 19 August 2015].
31. Uloric. U. S. Food and Drug Administration. Drug approval package. United States, 2009. Available at: http: //www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000toc.cfm [Last accessed 19 August 2015].
32. The Pharmaceuticals and Medical Devices Agency annual report FY 2010. Japan, 2011: 147.
33. Uloric. Full prescribing information. U. S. Food and Drug Administration. United States, 2012: 2.
34. Perez-Ruiz F, Punzi L. Hyperuricemia and tissue monourate deposits: prospective therapeutic considerations. Eur Rev Med Pharmacol Sci, 2015 May, 19(9): 1549-1552.
35. Adenuric. Public Summary Document. Pharmaceutical Benefits Advisory Committee. Australia, 2015. Page 1.
36. Japanese Society of Gout and Nucleic Acid Metabolism. Digest of Guideline for the Management of Hyperuricemia and Gout: second edition. Gout and Nucleic Acid Metabolism, 2010, 34(1): 109-144.
37. Zyloprim. U.S. Food and Drug Administration. Drugs@FDA. United States, 2015 [Last accessed 19 August 2015].
38. Takano Y, Hase-Aoki K, Horiuchi H et al. Selectivity of febuxostat, a novel non-purine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci, 2005 Mar 4, 76(16): 1835-1847.
39. Okamoto K, Eger BT, Nishino T et al. An extremely potent inhibitor of xanthine oxidoreductase. Crystal structure of the enzymeinhibitor complex and mechanism of inhibition. J Biol Chem, 2003 Jan 17, 278(3): 1848-1855.
40. Osada Y, Tsuchimoto M, Fukushima H et al. Hypouricemic effect of the novel xanthine oxidase inhibitor, TEI-6720, in rodents. Eur J Pharmacol, 1993 Sep 14, 241(2-3): 183-188.
41. Khosravan R, Grabowski BA, 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 Pharmacokinet, 2006, 45(8): 821-841.
42. Khosravan R, Grabowski B, Wu JT et al. Effect of food or antacid on pharmacokinetics and pharmacodynamics of febuxostat in healthy subjects. Br J Clin Pharmacol, 2008 Mar, 65(3): 355-363.
43. Zhang M, DI X, Xu L et al. Pharmacokinetics and pharmacodynamics of febuxostat under fasting conditions in healthy individuals. Exp Ther Med, 2014 Feb, 7(2): 393-396.
44. Komoriya K, Hoshide S, Takeda K et al. Pharmacokinetics and pharmacodynamics of febuxostat (TMX-67), a non-purine selective inhibitor of xanthine oxidase/xanthine Downloaded by [University of California, San Diego] at 06: 48 07 March 2016 dehydrogenase (NPSIXO) in patients with gout and/or hyperuricemia. Nucleosides Nucleotides Nucleic Acids, 2004 Oct, 23(8-9): 1119-1122.
45. 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): 855-866.
46. 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.
47. Grabowski B, Khosravan R, Wu JT et al. Effect of hydrochlorothiazide on the pharmacokinetics and pharmacodynamics of febuxostat, a nonpurine selective inhibitor of xanthine oxidase. Br J Clin Pharmacol, 2010 Jul, 70(1): 57-64.
48. Hoshide S, Takahashi Y, Ishikawa T et al. PK/PD and safety of a single dose of TMX-67 (febuxostat) in subjects with mild and moderate renal impairment. Nucleosides Nucleotides Nucleic Acids, 2004 Oct, 23(8-9): 1117-1118.
49. Mayer MD, Khosravan R, Vernillet L et al. Pharmacokinetics and pharmacodynamics of febuxostat, a new non-purine selective inhibitor of xanthine oxidase in subjects with renal impairment. Am J Ther, 2005 Jan-Feb, 12(1): 22-34.
50. Khosravan R, Grabowski BA, Mayer MD et al. The effect of mild and moderate hepatic impairment on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol, 2006 Jan, 46(1): 88-102.
51. Khosravan R, Kukulka MJ, Wu JT et al. The effect of age and gender on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol, 2008 Sep, 48(9): 1014-1024. Downloaded by [University of California, San Diego] at 06: 48 07 March 2016.
52. Doré M, Frenette AJ, Mansour AM et al. Febuxostat as a novel option to optimize thiopurines’ metabolism in patients with inadequate metabolite levels. Ann Pharmacother, 2014 May, 48(5): 648-651.
53. Febuxostat. ClincalTrials.gov. United States, 2015. Available at: https: //clinicaltrials.gov/ct2/results?term=febuxostat&pg=1 [Last accessed 23 August 2015].
54. Febuxostat. International Clinical Trials Registry Platform. World Health organization, 2015. Available at: http: //apps.who.int/trialsearch/default.aspx [Last accessed 25 August 2015].
55. Tayar JH, Lopez-Olivo MA, Suarez-Almazor ME. Febuxostat for treating chronic gout. Cochrane Database Syst Rev, 2012 Nov 14, 11: CD008653.
56. Gray CL, Walters-Smith NE. Febuxostat for treatment of chronic gout. Am J Health Syst Pharm, 2011 Mar 1, 68(5): 389-398.
57. Becker MA, Schumacher HR, Wortmann RL et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med, 2005, 353: 2450–2461.
58. Becker MA, Schumacher HR Jr, Wortmann RL et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight day, multicenter, phase II, randomized, doubleblind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum, 2005, 52: 916–923.
59. 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, 59: 1540–1548. Downloaded by [University of California, San Diego] at 06: 48 07 March 2016.
60. 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, 2010, 12: R63.
61. Schumacher HR, Becker MA, Lloyd E, et al. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy study. Rheumatology, 2009, 48: 188–194.
62. Becker MA, Schumacher HR, MacDonald PA et al. Clinical efficacy and safety of successful long-term urate lowering with febuxostat or allopurinol in subjects with gout. J Rheumatol, 2009, 36: 1273–1282.
63. Kamatani N, Fujimori S, Hada T et al. Placebocontrolled double-blind dose-response study of the non-purine-selective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 clinical study. J Clin Rheumatol, 2011 Jun, 17(4 Suppl 2): S35-43.
64. Kamatani N, Fujimori S, Hada T et al. An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purineselective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. J Clin Rheumatol, 2011 Jun, 17(4 Suppl 2): S44-49.
65. Kamatani N, Fujimori S, Hada T et al. An allopurinol-controlled, randomized, double-dummy, double-blind, parallel between-group, comparative study of febuxostat (TMX-67), a nonpurineselective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol, 2011 Jun, 17(4 Suppl 2): S13-18.
66. Kamatani N, Fujimori S, Hada T et al. Placebocontrolled, double-blind study of the nonpurineselective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with Downloaded by [University of California, San Diego] at 06: 48 07 March 2016 hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol, 2011 Jun, 17(4 Suppl 2): S19-26.
67. Perez-Ruiz F, Chinchilla S, Atxotegi J et al. Rheumatology International, 2015, 35(11): 1857-1861.
68. MacDonald TM, Ford I, Nuki G et al. Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, 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.
69. White WB, 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.
70. Sánchez-Lozada LG, Tapia E, Soto V et al. Treatment with the xanthine oxidase inhibitor febuxostat lowers uric acid and alleviates systemic and glomerular hypertension in experimental hyperuricaemia. Nephrol Dial Transplant, 2008 Apr, 23(4): 1179-1185.
71. Whelton A, Macdonald PA, Zhao L et al. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol, 2011 Jan, 17(1): 7-13.
72. Sircar D, Chatterjee S, Waikhom R et al. Efficacy of Febuxostat for Slowing the GFR Decline in Patients With CKD and Asymptomatic Hyperuricemia: A 6-Month, Double-Blind, Randomized, Placebo-Controlled Trial. Am J Kidney Dis, 2015, DOI: 10.1053/j.ajkd.2015.05.017. Downloaded by [University of California, San Diego] at 06: 48 07 March 2016
73. Sofue T, Inui M, Hara T et al. Efficacy and safety of febuxostat in the treatment of hyperuricemia in stable kidney transplant recipients. Drug Des Deliv Ther, 2014 Feb 17, 8: 245-253.
74. Richette P, Frazier A, Bardin T. Impact of antiinflammatory therapies, xanthine oxidase inhibitors and other urate-lowering therapies on cardiovascular diseases in gout. Curr Opin Rheumatol, 2015 Mar, 27(2): 170-174.
Рецензия
Для цитирования:
Петрова МС, Мазуров ВИ, Инамова ОВ. ФЕБУКСОСТАТ ДЛЯ ЛЕЧЕНИЯ ХРОНИЧЕСКОЙ ГИПЕРУРИКЕМИИ У ПАЦИЕНТОВ, СТРАДАЮЩИХ ПОДАГРОЙ. Медицинский Совет. 2017;(17):114-122. https://doi.org/10.21518/2079-701X-2017-17-114-122
For citation:
Petrova MS, Mazurov VI, Inamova OV. FEBUXOSTAT FOR TREATMENT OF CHRONIC HYPERURICEMIA IN GOUT PATIENTS. Meditsinskiy sovet = Medical Council. 2017;(17):114-122. (In Russ.) https://doi.org/10.21518/2079-701X-2017-17-114-122