Effects of febuxostat on serum urate level in Japanese hyperuricemia patients.

Objective. We assessed the efficacy and adverse effects of febuxostat in male hyperuricemia patients. Subjects and methods. This was a 12-week, multicenter, open-label, uncontrolled study. The enrolled subjects were 89 hyperuricemic male patients (12 overexcretors, 56 normal excretors, and 21 underexcretors). The endpoint was percent change in serum urate level. Results. The concentration of urate in serum before and 12 weeks after beginning administration of febuxostat in the overexcretors was 9.34 +/- 1.48 and 5.59 +/- 1.17 mg/dl, respectively, while those were 8.59 +/- 1.24 and 5.41 +/- 1.35 mg/dl, respectively, in the normal excretors, and 8.29 +/- 1.01 and 5.11 +/- 1.71 mg/dl, respectively, in the underexcretors. After 12 weeks, the rate of change in serum urate after beginning administration of febuxostat was - 0.384 +/- 0.186 in the overexcretors, - 0.368 +/- 0.128 in the normal excretors, and - 0.365 +/- 0.217 in the underexcretors, with no significant differences among them. A common adverse event related to febuxostat was gout flare. Conclusion. Febuxostat effectively reduced the concentration of urate in serum in hyperuricemic patients regardless of the level of uric acid excreted in urine without severe adverse effects.