Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study

Rheumatology

Volumn 48, Issue 2, 2009, Pages 188-194

  Schumacher Jr , H R ^a   Becker, M A ^b   Lloyd, E ^c   MacDonald, P A ^c   Lademacher, C ^c  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c TAKEDA PHARMACEUTICALS   (United States)

Author keywords

Allopurinol; Febuxostat; Gout; Hyperuricaemia

Indexed keywords

ANALGESIC AGENT; ANTIINFLAMMATORY AGENT; ANTILIPEMIC AGENT; COLCHICINE; DIURETIC AGENT; FEBUXOSTAT; URIC ACID;

ABDOMINAL PAIN; ADULT; AGED; ALZHEIMER DISEASE; APPENDIX PERFORATION; ARTHROPATHY; ARTICLE; ATRIOVENTRICULAR BLOCK; BASAL CELL CARCINOMA; CHOLECYSTITIS; CLINICAL TRIAL; CONCUSSION; CONNECTIVE TISSUE DISEASE; CREATININE BLOOD LEVEL; DEPRESSION; DIARRHEA; DISEASE EXACERBATION; DIVERTICULITIS; DIVERTICULOSIS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG INDUCED CANCER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSESTHESIA; EDEMA; FEMALE; FRACTURE; FRAGILITY FRACTURE; GASTROINTESTINAL PAIN; GASTROINTESTINAL SYMPTOM; GOUT; HEART ATRIUM FIBRILLATION; HEART DISEASE; HEART INFARCTION; HEPATOBILIARY DISEASE; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; INFECTION; INFLUENZA; INTERVERTEBRAL DISK DEGENERATION; KIDNEY DYSFUNCTION; LIMB INJURY; LIVER FUNCTION TEST; LONG TERM CARE; LOWER RESPIRATORY TRACT INFECTION; LUNG INFECTION; LUNG TUMOR; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEPHROTOXICITY; OPEN STUDY; OSTEOARTHRITIS; OSTEOARTHROPATHY; OUTCOME ASSESSMENT; PAIN; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROSTATE CANCER; RASH; ROTATOR CUFF INJURY; SIDE EFFECT; SKIN INJURY; SMALL INTESTINE OBSTRUCTION; SPINAL CORD DISEASE; TENDON DISEASE; THORAX PAIN; TONGUE CANCER; UPPER RESPIRATORY TRACT INFECTION; URIC ACID BLOOD LEVEL; URINARY TRACT DISEASE; URINARY TRACT INFECTION; URINE RETENTION; VERTEBRAL CANAL STENOSIS;

ADULT; AGED; BIOLOGICAL MARKERS; CLINICAL TRIALS, PHASE II AS TOPIC; FEMALE; FOLLOW-UP STUDIES; GOUT; GOUT SUPPRESSANTS; HUMANS; JOINTS; MALE; MIDDLE AGED; THIAZOLES; TREATMENT OUTCOME; URIC ACID; YOUNG ADULT;

EID: 58749106802     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ken457     Document Type: Article

References (36)

1. Fiddis RW, Vlachos N, Calvert PD. Studies of urate crystallisation in relation to gout. Ann Rheum Dis 1983;42(Suppl. 1):12-5.
2. Kippen I, Klinenberg JR, Weinberger A, Wilcox WR. Factors affecting urate solubility in vitro. Ann Rheum Dis 1974;33:313-7.
3. 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.
4. Alvarez-Nemegyei J, Medina-Escobedo M, Villanueva-Jorge S, Vazquez-Mellado J. Prevalence and risk factors for urolithiasis in primary gout: Is a reappraisal needed? J Rheumatol 2005;32:2189-91.
5. 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, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005;52:916-23.
6. Li-Yu J, Clayburne G, Sieck M et al. Treatment of chronic gout. Can we determine when urate stores are depleted enough to prevent attacks of gout? J Rheumatol 2001;28:577-80.
7. Perez-Ruiz F, Atxotegi J, Hernando I, Calabozo M, Nolla JM. Using serum urate levels to determine the period free of gouty symptoms after withdrawal of long-term urate-lowering therapy: A prospective study. Arthritis Rheum 2006;55: 786-90.
8. Perez-Ruiz F, Calabozo M, Pijoan JI, 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.
9. Zhang W, Doherty M, Bardin T 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;65:1312-24.
10. Richette P, Briere C, Hoenen-Clavert V, Loeuille D, Bardin T. Rasburicase for tophaceous gout not treatable with allopurinol: An exploratory study. J Rheumatol 2007;34:2093-8.
11. Sundy JS, Becker MA, Baraf HS et al. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: Results of a phase II randomized study. Arthritis Rheum 2008;58:2882-91.
12. 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.
13. 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.
14. Takano Y, Hase-Aoki K, Horiuchi H et al. Selectivity of febuxostat, a novel nonpurine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci 2005; 76:1835-47.
15. 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.
16. Schumacher HR Jr. Febuxostat: A non-purine, selective inhibitor of xanthine oxidase for the management of hyperuricaemia in patients with gout. Expert Opin Investig Drugs 2005;14:893-903.
17. Becker MA, Kisicki J, Khosravan 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.
18. Schumacher HR, Becker MA, Wortmann RL et al. Febuxostat vs allopurinol and placebo in subjects with hyperuricemia and gout: The 28-week APEX study. Arthritis Rheum 2005;52:S680.
19. Becker MA, Schumacher HR Jr, Wortmann RL et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005;353: 2450-61.
20. Terkeltaub RA. Clinical practice. Gout. N Engl J Med 2003;349:1647-55.
21. 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.
22. Sarawate CA, Patel PA, Schumacher HR, Yang W, Brewer KK, Bakst AW. Serum urate levels and gout flares: Analysis from managed care data. J Clin Rheumatol 2006;12:61-5.
23. McCarthy GM, Barthelemy CR, Veum JA, Wortmann RL. Influence of antihyperuricemic therapy on the clinical and radiographic progression of gout. Arthritis Rheum 1991;34:1489-94.
24. Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol 2004;31:2429-32.
25. Riedel AA, Nelson M, Joseph-Ridge N, Wallace K, MacDonald P, Becker M. Compliance with allopurinol therapy among managed care enrollees with gout: A retrospective analysis of administrative claims. J Rheumatol 2004;31:1575-81.
26. Sarawate CA, Brewer KK, Yang W et al. Gout medication treatment patterns and adherence to standards of care from a managed care perspective. Mayo Clin Proc 2006;81:925-34.
27. Neogi T, Hunter DJ, Chaisson CE, Allensworth-Davies D, Zhang Y. Frequency and predictors of inappropriate management of recurrent gout attacks in a longitudinal study. J Rheumatol 2006;33:104-9.
28. Roddy E, Zhang W, Doherty M. Concordance of the management of chronic gout in a UK primary-care population with the EULAR gout recommendations. Ann Rheum Dis 2007;66:1311-5.
29. Singh JA, Hodges JS, Toscano JP, Asch SM. Quality of care for gout in the US needs improvement. Arthritis Rheum 2007;57:822-9.
30. Hochberg MC, Thomas J, Thomas DJ, Mead L, Levine DM, Klag MJ. Racial differences in the incidence of gout. The role of hypertension. Arthritis Rheum 1995;38:628-32.
31. Klemp P, Stansfield SA, Castle B, Robertson MC. Gout is on the increase in New Zealand. Ann Rheum Dis 1997;56:22-6.
32. 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;23:1117-8.
33. Khosravan R, Grabowski BA, Mayer MD, Wu JT, Joseph-Ridge N, Vernillet L. 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;46:88-102.
34. 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.
35. Schumacher HR, Taylor W, Joseph-Ridge N et al. Outcome evaluations in gout. J Rheumatol 2007;34:1381-5.
36. Schumacher HR Jr, Becker MA, Palo WA, Streit J, MacDonald PA, Joseph-Ridge N. Tophaceous gout: Quantitative evaluation by direct physical measurement. J Rheumatol 2005;32:2368-72.