Gout arthritis is associated with severe pain, redness and tenderness in joints. Febuxostat has proved to be adequate and safe to help curb renal impairment in gout. This study has shown that it significantly lowers the serum uric acid without any significant deterioration in renal function.

Renal impairment is a risk factor for gout and a barrier to optimal gout management. Data regarding the safety and efficacy of febuxostat in subjects with moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] ≥ 15 to < 50 mL/min) are limited. This exploratory study addresses this evidence gap.

96 subjects with moderate to severe renal impairment and gout enrolled in a 12 month multicenter, randomized, double-blind, placebo-controlled study. Subjects were randomized to febuxostat 30 mg BID, febuxostat 40/80 mg QD, or placebo. The primary efficacy endpoint was the change from baseline (CFB) in serum creatinine (sCr) to month 12. Secondary endpoints included CFB in eGFR to month 12 and proportion of subjects with serum urate (sUA) < 6.0 mg/dL at month 12.

At month 12 there were no significant differences in sCr CFB in either febuxostat group compared to placebo; similarly, there were no significant differences in eGFR CFB at month 12. The proportion of subjects at month 12 with sUA < 6.0 mg/dL was significantly greater in both febuxostat groups compared to placebo (P<0.001). Treatment emergent adverse events (≥1) occurred in 78.1%, 87.5%, and 78.1% of febuxostat 30 mg BID, febuxostat 40/80 mg QD, and placebo-treat subjects, respectively; events most frequently involved renal impairment and renal function analyses categories.

Febuxostat proved efficacious and well tolerated in gout subjects with moderate to severe renal impairment. Subjects randomized to febuxostat demonstrated significantly lower sUA and no significant deterioration in renal function.