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Rheumatology 2009 48(Supplement 2):ii15-ii19; doi:10.1093/rheumatology/kep088
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

This article appears in the following Rheumatology issue: Can we make gout crystal clear? Proceedings of a satellite symposium held on the occasion of the EULAR Congress, Paris, France, June 13, 2008 [View the issue table of contents]

Febuxostat: a new treatment for hyperuricaemia in gout

N. Lawrence Edwards1

1Department of Medicine, University of Florida, Gainesville, FL, USA

Correspondence to: N. Lawrence Edwards, Department of Medicine, University of Florida, Gainesville, FL 32610, USA. E-mail: edwarnl{at}medicine.ufl.edu


   Abstract

Febuxostat is a new non-purine xanthine oxidase inhibitor that is more potent than allopurinol 300 mg daily. In two Phase III trials, significantly more febuxostat-treated gout patients met the primary endpoint [serum urate (sUA) <6 mg/dl (<360 µmol/l) at the last three visits] (48 and 53% with 80 mg; 65 and 62% with 120 mg), compared with those receiving allopurinol 300 mg (22 and 21%; P < 0.001 in both studies). Febuxostat was more effective than allopurinol in the subset with impaired renal function; no dose adjustment is required in mild-to-moderate renal impairment. Long-term extension studies confirmed the efficacy and tolerability of febuxostat. In patients who achieved the sUA target of 6 mg/dl (360 µmol/l), the incidence of gout flares fell steadily and tophi resolved in many patients. The incidence of adverse events such as dizziness, diarrhoea, headache and nausea with febuxostat was similar to allopurinol. The incidence of cardiovascular side-effects (Antiplatelet Trialists Collaboration events) was numerically higher with febuxostat than with allopurinol, but this was not statistically significant. Co-administration of febuxostat with AZA or 6-mercaptopurine is not recommended. Prophylaxis (colchicine and/or NSAIDs) against acute attacks should be used for at least the first 6 months, since early mobilization flares were observed in the clinical trials. In conclusion, febuxostat is more effective than allopurinol 300 mg daily in reducing sUA levels <6 mg/dl (360 µmol/l), the target recommended by EULAR, and offers a new option for the long-term treatment of gout.

KEY WORDS: Gout, Urate-lowering therapy, Allopurinol, Febuxostat, Clinical studies, sUA target, Adverse events

Submitted 18 December 2008; revised version accepted 18 March 2009.
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