Kenneth G. Saag, MD, MSc, from Birmingham VA Medical Center, Birmingham, AL, and colleagues conducted a 12-month multicenter, randomized, double-blind, placebo-controlled study to determine the safety and efficacy of febuxostat in gout patients with estimated glomerular filtration rate (eGFR) ≥15–<50mL/min.
A total of 96 patients were randomized to febuxostat 30mg twice daily, febuxostat 40mg daily, febuxostat 80mg daily, or placebo. The primary endpoint was the change was from baseline in serum creatinine to Month 12. Secondary endpoints included change from baseline in eGFR to Month 12 and proportion of patients with serum urate <6mg/dL at Month 12.
Data showed no significant differences in change from baseline for serum creatinine in either febuxostat groups vs. placebo group at Month 12. There were also no significant differences in change from baseline for eGFR at Month 12. More patients in the febuxostat groups had serum urate levels <6mg/dL at Month 12 vs. patients in the placebo group (P<0.001).
Overall, patients randomized to febuxostat showed significantly lower serum urate levels and no significant worsening of renal function.
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