Febuxostat compared with allopurinol in patients with hyperuricemia and gout

New England Journal of Medicine

Volumn 353, Issue 23, 2005, Pages 2450-2461

  Becker, Michael A ^a,e   Schumacher Jr , H Ralph ^b   Wortmann, Robert L ^c   MacDonald, Patricia A ^d   Eustace, Denise ^d   Palo, William A ^d   Streit, Janet ^d   Joseph Ridge, Nancy ^d  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF OKLAHOMA   (United States)

^d TAP Pharmaceutical Products   (United States)

^e UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLOPURINOL; COLCHICINE; FEBUXOSTAT; NAPROXEN;

ADULT; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONCENTRATION (PARAMETERS); CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DOSE RESPONSE; FEMALE; GOUT; HUMAN; HYPERURICEMIA; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; URIC ACID BLOOD LEVEL;

ALLOPURINOL; DOUBLE-BLIND METHOD; ENZYME INHIBITORS; FEMALE; GOUT; GOUT SUPPRESSANTS; HUMANS; HYPERURICEMIA; MALE; MIDDLE AGED; THIAZOLES; URIC ACID; XANTHINE OXIDASE;

EID: 28944437578     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa050373     Document Type: Article

References (37)

1. Wortmann RL. Gout and hyperuricemia. Curr Opin Rheumatol 2002;14:281-6.
2. Wortmann RL, Kelley WN. Gout and hyperuricemia. In: Ruddy S, Harris ED Jr, Sledge CB, eds. Kelley's textbook of rheumatology. 6th ed. Philadelphia: W.B. Saunders, 2001:1339-48.
3. Allen DJ, Milosovich G, Mattocks AM. Inhibition of monosodium urate needle crystal growth. Arthritis Rheum 1965;8:1123-33.
4. Loeb JN. The influence of temperature on the solubility of monosodium urate. Arthritis Rheum 1972;15:189-92.
5. Wilcox WR, Khalaf A, Weinberger A, Kippen I, Klinenberg JR. Solubility of uric acid and monosodium urate. Med Biol Eng 1972;10:522-31.
6. Bluestone R, Kippen I, Campion D, Klinenberg J, Whitehouse M. Urate binding: a clue to the pathogenesis of gout. J Rheumatol 1974;1:230-5.
7. Tak HK, Cooper SM, Wilcox WR. Studies on the nucleation of monosodium urate at 37 degrees C. Arthritis Rheum 1980;23:574-80.
8. Perl-Treves D, Addadi L. A structural approach to pathological crystallizations - gout: the possible role of albumin in sodium urate crystallization. Proc R Soc Lond B Biol Sci 1988;235:145-59.
9. Fiddis RW, Vlachos N, Calvert PD. Studies of urate crystallisation in relation to gout. Ann Rheum Dis 1983;42:Suppl 1:12-5.
10. Shoji A, Yamanaka H, Kamatani N. A retrospective study of the relationship between serum urate level and recurrent attacks of gouty arthritis: evidence for reduction of recurrent gouty arthritis with antihyperuricemic therapy. Arthritis Rheum 2004;51:321-5.
11. Perez-Ruiz F, Calabozo M, Pijoan J, Herrero-Beites AM, Ruibal A. Effect of urate-lowering therapy on the velocity of size reduction of tophi in chronic gout. Arthritis Rheum 2002;47:356-60.
12. Perez-Ruiz F, Alonso-Ruiz A, Calabozo M, Herrero-Beites A, Garcia-Erauskin G, Ruiz-Lucea E. Efficacy of allopurinol and benzbromarone for the control of hyperuricaemia: a pathogenic approach to the treatment of primary chronic gout. Ann Rheum Dis 1998;57:545-9.
13. Schlesinger N, Schumacher HR Jr. Gout: can management be improved? Curr Opin Rheumatol 2001;13:240-4.
14. Schlesinger N. Management of acute and chronic gouty arthritis: present state-of-the-art. Drugs 2004;64:2399-416.
15. Terkeltaub RA. Gout. N Engl J Med 2003;349:1647-55.
16. Fam AG. Gout in the elderly: clinical presentation and treatment. Drugs Aging 1998;13:229-43.
17. Harris MD, Siegel LB, Alloway JA. Gout and hyperuricemia. Am Fam Physician 1999;59:925-34.
18. Okamoto K, Eger BT, Nishino T, Kondo S, Pai EF, Nishino T. An extremely potent inhibitor of xanthine oxidoreductase: crystal structure of the enzyme-inhibitor complex and mechanism of inhibition. J Biol Chem 2003;278:1848-55.
19. 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;76:1835-47.
20. Horiuchi H, Ota M, Kobayashi M, et al. A comparative study on the hypouricemic activity and potency in renal xanthine calculus formation of two xanthine oxidase/xanthine dehydrogenase inhibitors: TEI-6720 and allopurinol in rats. Res Commun Mol Pathol Pharmacol 1999;104:307-19.
21. Osada Y, Tsuchimoto M, Fukushima H, et al. Hypouricemic effect of the novel xanthine oxidase inhibitor, TEI-6720, in rodents. Eur J Pharmacol 1993;241:183-8.
22. Becker MA, Kisicki J, Khosraven R, et al. Febuxostat (TMX-67), a novel, non-purine, selective inhibitor of xanthine oxidase, is safe and decreases serum urate in healthy volunteers. Nucleosides Nucleotides Nucleic Acids 2004;23:1111-6.
23. Hoshide S, Nishimura S, Ishii S, Matsuzawa K, Saito N, Tanaka T. Metabolites of TMX-67, a new pharmaceutical entity for the treatment of gout or hyperuricemia, and their pharmacokinetic profiles in humans. Drug Metab Rev 2000;32:Suppl 2:269.
24. Khosravan R, Mayer M, Grabowski B, Vernillet L, Wu J-T, Joseph-Ridge N. Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase - effect of mild and moderate hepatic impairment on pharmacokinetics, pharmacodynamics, and safety. Arthritis Rheum 2004;50:S337. abstract.
25. Mayer MD, Khosravan R, Vernillet L, Wu JT, Joseph-Ridge N, Mulford DJ. Pharmacokinetics and pharmacodynamics of febuxostat, a new non-purine selective inhibitor of xanthine oxidase, in subjects with renal impairment. Am J Ther 2005;12:22-34.
26. Wallace SL, Robinson H, Masi AT, Decker JL, McCarty DJ, Yu TF. Preliminary criteria for the classification of the acute arthritis of primary gout. Arthritis Rheum 1977;20:895-900.
27. Kot TV, Day RO, Brooks PM. Preventing acute gout when starting allopurinol therapy: colchicine or NSAIDs? Med J Aust 1993;159:182-4.
28. Yu TF, Gutman AB. Efficacy of colchicine prophylaxis in gout: prevention of recurrent gouty arthritis over a mean period of five years in 208 gouty subjects. Ann Intern Med 1961;55:179-92.
29. Schumacher HR, Becker MA, Palo W, Hunt B, MacDonald PA, Joseph-Ridge N. Tophaceous gout - quantitative evaluation by direct physical measurement. J Rheumatol (in press).
30. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988;75:800-2.
31. Brewis I, Ellis RM, Scott JT. Single daily dose of allopurinol. Ann Rheum Dis 1975;34:256-9.
32. Rodnan GP, Robin JA, Tolchin SF, Elion GB. Allopurinol and gouty hyperuricemia: efficacy of a single daily dose. JAMA 1975;231:1143-7.
33. Yamanaka H, Togashi R, Hakoda M, et al. Optimal range of serum urate concentrations to minimize risk of gouty attacks during anti-hyperuricemic treatment. Adv Exp Med Biol 1998;431:13-8.
34. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
35. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;20:109-17.
36. Campion EW, Glynn RJ, DeLabry LO. Asymptomatic hyperuricemia: risks and consequences in the Normative Aging Study. Am J Med 1987;82:421-6.
37. Hall AP, Barry PE, Dawber TR, Mc-Namara PM. Epidemiology of gout and hyperuricemia: a long-term population study. Am J Med 1967;42:27-37.