Сравнительная эффективность и безопасность терапии по снижению уровня уратов для лечения гиперурикемии
Аннотация
Распространенность гиперурикемии и подагры возрастает, но до сих пор не проведена оценка сравнительной эффективности и безопасности различных методов их лечения. Целью сетевого метаанализа было сравнение эффективности и безопасности различных методов лечения гиперурикемии. Систематическому анализу были подвергнуты 15 рандомизированных контролируемых исследований (РКИ) с участием 7246 пациентов в период до января 2016 г., в которых сравнивали эффективность различных препаратов, снижающих уровень мочевой кислоты (МК) (аллопуринол, бензбромарон, фебуксостат, пеглотиказу и пробенецид) при гиперурикемии. Эффективность и безопасность лекарственных средств (как исходы данного анализа) оценивались по достижению целевого уровня МК в сыворотке и возникновению нежелательных явлений (НЯ), независимо от их наличия. Эффективность (ее показатели, выраженные как отношения шансов (ОШ) и 95% доверительные интервалы (ДИ)) и безопасность лекарственных средств оценивались по совокупным вероятностям градации. Результаты показывают, что фебуксостат, бензбромарон, пробенецид, пеглотиказа и аллопуринол были очень эффективными в лечении гиперурикемии по сравнению с плацебо. Фебуксостат обладал большей эффективностью и безопасностью по сравнению с другими препаратами. Кроме того, фебуксостат 120 мг при приеме 1 р/сут был более эффективным при снижении уровня уратов (ОШ: 0,17, 95% ДИ: 0,12–0,24) и безопаснее (OR: 0,72, 95% ДИ: 0,56–0,91), чем аллопуринол.
По материалам статьи Comparative efcacy and safety of urate-lowering therapy for the treatment of hyperuricemia: a systematic review and network meta-analysis. Shu Li, Hongxi Yang, Yanan Guo, Fengjiang Wei, Xilin Yang, Daiqing Li, Mingzhen Li, Weili Xu, Weidong Li, Li Sun, Ying Gao & Yaogang Wang
Список литературы
1. Becker MA et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med, 2005, 353: 2450–2461.
2. Smith E et al. The global burden of gout: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis, 2014, 73: 1470–1476.
3. Roddy E, Choi HK. Epidemiology of gout. Rheum Dis Clin North Am, 2014, 40: 155–175.
4. Conen D et al. Prevalence of hyperuricemia and relation of serum uric acid with cardiovascular risk factors in a developing country. BMC Public Health, 2004, 4(9).
5. Qiu L et al. Prevalence of hyperuricemia and its related risk factors in healthy adults from Northern and Northeastern Chinese provinces. BMC Public Health, 2013, 13(664).
6. AstraZeneca announces top-line results from the Phase III programme of lesinurad in combination with xanthine oxidase inhibitors in gout patients. Available at: https://www.astrazeneca.com/our-company/media-centre/pressreleases/2014/astrazeneca-lesinurad-xanthineoxidase-results-gout-patients-13082014.html (Accessed: 15th February 2016) (2014).
7. Pittman JR, Bross MH. Diagnosis and management of gout. Am Fam Physician, 1999, 59: 1799–1806, 1810.
8. Lin KC, Lin HY, Chou P. Te interaction between uric acid level and other risk factors on the development of gout among asymptomatic hyperuricemic men in a prospective study. J Rheumatol, 2000, 27: 1501–1505.
9. Retrospective analysis of a large cohort. Clin Rheumatol, 2014, 33: 549–553.
10. Luk AJ, Simkin PA. Epidemiology of hyperuricemia and gout. Am J Manag Care, 11: S435–S442, quiz S465-438.
11. Neogi T. Clinical practice. Gout. N Engl J Med, 2011, 364: 443–452.
12. Roddy E, Mallen CD, Doherty M. Gout. BMJ, 2013, 347.
13. Johnson R J, Kivlighn S D, Kim Y G, Suga S, Fogo AB. Reappraisal of the pathogenesis and consequences of hyperuricemia in hypertension, cardiovascular disease, and renal disease. Am J Kidney Dis, 1999, 33: 225–234.
14. Edwards NL. Te role of hyperuricemia and gout in kidney and cardiovascular disease. Cleve Clin J Med, 2008, 75 Suppl 5: 13–16.
15. Stamp LK, Chapman PT. Urate-lowering therapy: current options and future prospects for elderly patients with gout. Drugs Aging, 2014, 31: 777–786.
16. Khanna D et al. American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res, 2012, 64: 1431–1446.
17. Jansen TL, Reinders MK, van Roon EN, Brouwers JR. Benzbromarone withdrawn from the European market: another case of “absence of evidence is evidence of absence”? Clin Exp Rheumatol, 2004, 22: 651.
18. Lee MH, Graham GG, Williams KM, Day RO. A beneft-risk assessment of benzbromarone in the treatment of gout. Was its withdrawal from the market in the best interest of patients? Drug Saf, 2008, 31: 643–665.
19. Ramasamy SN et al. Allopurinol hypersensitivity: a systematic review of all published cases, 1950-2012. Drug Saf, 2013, 36: 953–980.
20. Wu XW, Muzny DM, Lee CC, Caskey C T. Two independent mutational events in the loss of urate oxidase during hominoid evolution. J Mol Evol, 1992, 34: 78–84.
21. Diaz-Torne C, Perez-Herrero N, Perez-Ruiz F. New medications in development for the treatment of hyperuricemia of gout. Curr Opin Rheumatol, 2015, 27: 164–169.
22. Sivera F et al. Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative. Ann Rheum Dis, 2014, 73: 328–335.
23. Ye P et al. Efcacy and tolerability of febuxostat in hyperuricemic patients with or without gout: a systematic review and meta-analysis. Clin Ter, 2013, 35: 180–189.
24. Faruque LI et al. A systematic review and metaanalysis on the safety and efcacy of febuxostat versus allopurinol in chronic gout. Semin Arthritis Rheum, 2013, 43: 367–375.
25. Bucher HC, Guyatt GH, Grifth LE, Walter SD. Te results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol, 1997, 50: 683–691.
26. Caldwell DM, Ades AE Higgins JP. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ, 2005, 331: 897–900.
27. Chen X, Liu MX, Yan GY. Drug-target interaction prediction by random walk on the heterogeneous network. Mol Biosyst, 2012, 8: 1970–1978.
28. Chen X et al. Drug-target interaction prediction: databases, web servers and computational models. Brief Bioinform, 2016, 17: 696–712.
29. Chen X et al. NLLSS: Predicting Synergistic Drug Combinations Based on Semi-supervised Learning. PLoS Comput Biol, 2016, 12: e1004975.
30. Wang E et al. Predictive genomics: a cancer hallmark network framework for predicting tumor clinical phenotypes using genome sequencing data. Semin Cancer Biol, 2015, 30: 4–12.
31. Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med, 2002, 21: 2313–2324.
32. Hutton B et al. Te PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-analyses of Health Care Interventions: Checklist and ExplanationsPRISMA Extension for Network Metaanalysis. Ann Intern Med, 2015, 162: 777–784.
33. O’Connor D, Green S, Higgins JP. In Cochrane Hand book for Systematic Reviews of Interventions: Cochrane Book Series (eds Higgins, J. P. & Green, S.), 2008, Ch. 5: 81–94 (John Wiley & Sons, Ltd).
34. Becker MA et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twentyeight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efcacy in patients with gout. Arthritis Rheum, 2005, 52: 916–923.
35. Becker MA et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ter, 2010, 12: R63.
36. Huang X et al. An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia. Int J Rheum Dis, 2014, 17: 679–686.
37. Kamatani N et al. An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. J Clin Rheumatol, 2011, 17: 44–49
38. Kamatani N et al. An allopurinol-controlled, randomized, double-dummy, double-blind, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol, 2011, 17: 13–18.
39. Kamatani N et al. Placebo-controlled doubleblind dose-response study of the non-purineselective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 clinical study. J Clin Rheumatol, 2011, 17: 35–43.
40. Kamatani N. et al. Placebo-controlled, doubleblind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol, 2011, 17: 19–26.
41. Perez-Ruiz F et al. Treatment of chronic gout in patients with renal function impairment: an open, randomized, actively controlled study. J Clin Rheumatol, 1999, 5: 49–55.
42. Reinders MK et al. Efcacy and tolerability of urate-lowering drugs in gout: a randomised controlled trial of benzbromarone versus probenecid afer failure of allopurinol. Ann Rheum Dis, 2009, 68: 51–56.
43. Reinders MK et al. A randomised controlled trial on the efcacy and tolerability with dose escalation of allopurinol 300–600 mg/ day versus benzbromarone 100–200 mg/day in patients with gout. Ann Rheum Dis, 2009, 68: 892–897.
44. Schumacher HR et al. Efects 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.
45. Sundy JS et al. Efcacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA, 2011, 306: 711–720.
46. Xu S. et al. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efcacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis, 2015, 18: 669–678.
47. Yu KH et al. Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study. Scand J Rheumatol, 2016, 45: 304–311.
48. Higgins JP, Altman DG. In Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series (eds Higgins, J. P. & Green, S.), 2008, Ch. 8: 187–241 (John Wiley & Sons, Ltd).
49. Higgins JP, Tompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ, 2003, 327: 557–560.
50. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment metaanalysis: an overview and tutorial. J Clin Epidemiol, 2011, 64: 163–171.
51. Li T, Puhan MA, Vedula SS, Singh S, Dickersin K. Network meta-analysis-highly attractive but more methodological research is needed. BMC Med., 2011, 9: 79.
52. Jansen JP et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health, 2011, 14: 417–428.
53. Jansen JP, Naci H. Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of efect modifers. BMC Med., 2013, 11: 159.
54. Ko TM et al. Use of HLA-B*58:01 genotyping to prevent allopurinol induced severe cutaneous adverse reactions in Taiwan: national prospective cohort study. BMJ, 2015, 351: h4848.
55. Beard SM, von Scheele BG, Nuki G, Pearson IV. Cost-efectiveness of febuxostat in chronic gout. Eur J Health Econ., 2014, 15: 453–463.
56. Tayar JH, Lopez-Olivo MA, Suarez-Almazor ME. Febuxostat for treating chronic gout. Cochrane Database Syst Rev., 2013, 11: 202–203.
57. Zhang W 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 Terapeutics (ESCISIT). Ann Rheum Dis., 2006, 65: 1312–1324.
Рецензия
Для цитирования:
Сравнительная эффективность и безопасность терапии по снижению уровня уратов для лечения гиперурикемии. Медицинский Совет. 2018;(9):68-81.
For citation:
Comparative efcacy and safety of urate-lowering therapy for the treatment of hyperuricemia. Meditsinskiy sovet = Medical Council. 2018;(9):68-81. (In Russ.)
Просмотров:
3658
Послать статью по эл. почте 