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Febuxostat: A Review of Its Use in the Treatment of Hyperuricaemia in Patients with Gout

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Abstract

Febuxostat (Adenuric®, Uloric®, Feburic®) is an orally-active, potent, non-purine, selective xanthine oxidase inhibitor. In the EU, it is indicated in adults for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred. Unlike allopurinol, the prototypical xanthine oxidase inhibitor that is the cornerstone therapy for chronic gout, febuxostat does not require dosage adjustment in patients with mild or moderate renal impairment. In randomized, double-blind studies, 6–12 months’ treatment with febuxostat at dosages approved for use in the EU (80 and 120 mg/day) was significantly more effective in lowering serum uric acid (sUA) levels in patients with hyperuricaemia and gout than allopurinol at dosages commonly prescribed in practice (100–300 mg/day); febuxostat demonstrated greater urate-lowering efficacy than allopurinol in patients with renal impairment. In open-label extension studies, 3–5 years’ treatment with febuxostat maintained a target sUA level of <6.0 mg/dL in most patients; sustained reduction in sUA level was associated with near elimination of gout flares and improved tophus status. Febuxostat therapy was generally well tolerated during clinical development; frequently reported adverse events included liver function abnormalities, diarrhoea and rash. Cardiovascular (CV) events were the most common serious adverse events; the comparative safety of febuxostat and allopurinol is being examined further in large, ongoing trials in patients with gout who already have, or are at risk of developing, CV disease. In conclusion, febuxostat is a well established antihyperuricaemic agent that provides an effective alternative to allopurinol for the management of chronic gout.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. James Frampton is a salaried employee of Adis/Springer.

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    James E. Frampton

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Correspondence to James E. Frampton.

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The manuscript was reviewed by: L.R. Espinosa, Section of Rheumatology, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA; T.L. Jansen, Scientific Institute for Quality of Healthcare, Radboud University Medical Centre, Nijmegen, Netherlands; A.S. Jeyaruban, Faculty of Medicine, James Cook University, Townsville, Queensland, Australia; P.P. Khanna, Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.

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Frampton, J.E. Febuxostat: A Review of Its Use in the Treatment of Hyperuricaemia in Patients with Gout. Drugs 75, 427–438 (2015). https://doi.org/10.1007/s40265-015-0360-7

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