1529-0131a/asset/cover.gif?v=1&s=4b71f39689e424fbb0e6725b1c033cc646a4272b "Arthritis Care & Research")
Dr. Schumacher has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Takeda Global Research & Development Center, Inc., and Savient.
2151-4658/asset/olbannerleft.gif?v=1&s=75d1dd4933b4687fdb365bb32190b0a4ef453ee7)
2151-4658/asset/olbannerright.gif?v=1&s=a36ba6af41bd9af370864f6461a516746a709d31)
Gout
You have full text access to this OnlineOpen article
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†‡
Article first published online: 30 OCT 2008
DOI: 10.1002/art.24209
Copyright © 2008 by the American College of Rheumatology
Additional Information
How to Cite
Schumacher, H. R., Becker, M. A., Wortmann, R. L., MacDonald, P. A., Hunt, B., Streit, J., Lademacher, C. and Joseph-Ridge, N. (2008), 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 Care & Research, 59: 1540–1548. doi: 10.1002/art.24209
- †
ClinicalTrials.gov identifier: NCT00174915.
- ‡
Previously published in abstract form: Schumacher HR, Becker MA, Wortmann RL, MacDonald PA, Hunt B, Streit J, et al. Febuxostat vs allopurinol and placebo in subjects with hyperuricemia and gout: the 28-week APEX study [abstract]. Arthritis Rheum 2005;52 Suppl 9:S680.
Publication History
- Issue published online: 30 OCT 2008
- Article first published online: 30 OCT 2008
- Manuscript Accepted: 10 JUN 2008
- Manuscript Received: 20 DEC 2007
Funded by
- Takeda Global Research & Development Center, Inc., Deerfield, Illinois
- Takeda Global Research & Development Center, Inc.
- Abstract
- Article
- References
- Cited By
Abstract
Objective
To compare the urate-lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function.
Methods
Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once-daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks.
Results
Significantly (P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl compared with allopurinol (22%) and placebo (0%). A significantly (P < 0.05) higher percentage of subjects with impaired renal function treated with febuxostat 80 mg (4 [44%] of 9), 120 mg (5 [45%] of 11), and 240 mg (3 [60%] of 5) achieved the primary end point compared with those treated with 100 mg of allopurinol (0 [0%] of 10). Proportions of subjects experiencing any adverse event or serious adverse event were similar across groups, although diarrhea and dizziness were more frequent in the febuxostat 240 mg group. The primary reasons for withdrawal were similar across groups except for gout flares, which were more frequent with febuxostat than with allopurinol.
Conclusion
At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.