Febuxostat: a new drug for an old disease. Do we really need it?

BACKGROUND Febuxostat is a non-purine selective inhibitor of xanthine oxidase whose therapeutic effect is decreasing the serum uric acid concentration. Febuxostat has a marketing authorisation for the treatment of chronic hyperuricaemia in conditions where urate/uric acid deposition has already occurred. The recommended dose of febuxostat is 80 mg once daily. If the person's serum uric acid concentration is above 6 mg/dL after 2-4 weeks, febuxostat 120 mg once daily may be considered. The most common side effects associated with febuxostat are diarrhoea, nausea, headache, liver function test abnormalities and rash. The evidence in support of the clinical effectiveness of febuxostat in comparison with allopurinol is not strong.
DISCUSSION A meta-analysis showed that although the urate-lowering efficacy of febuxostat was statistically significantly higher than fixed-dose allopurinol (300 mg/day), a higher proportion of patients receiving febuxostat needed treatment for gout flares compared with those receiving fixed-dose allopurinol. For the febuxostat 80 mg/day group this difference was not statistically significant (p > 0.18), but for the 120 mg/day febuxostat group it was. Moreover, guidelines recommend dose titration for allopurinol according to therapeutic targets. It is possible that dose-titrated allopurinol may be more effective than fixed-dose allopurinol.
CONCLUSIONS Febuxostat is a plausible improvement on current second-line options. These options are considered where allopurinol is not appropriate, e.g. because of chronic kidney disease, intolerance or lack of response.