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 mumol/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 mumol/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 mumol/l), the target recommended by EULAR, and offers a new option for the long-term treatment of
gout.