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Objective  To assess the efficacy and safety of febuxostat extended release ( XR ) and immediate release ( IR ) in patients with gout and normal or impaired renal function.    Methods  This was a 3‐month, phase  III , multicenter, double‐blind, placebo‐controlled study. Patients (n = 1,790) with a history of gout and normal or impaired (mild‐to‐severe) renal function were randomized to receive placebo, febuxostat  IR  40 or 80 mg, or febuxostat  XR  40 or 80 mg once daily (1:1:1:1:1 ratio). End points included proportions of patients with a serum urate ( UA ) level of <5.0 mg/dl at month 3 (primary end point), a serum  UA  level of <6.0 mg/dl at month 3, and ≥1 gout flare requiring treatment over 3 months (secondary end points).    Results  Both febuxostat formulations led to significantly greater proportions of patients achieving a serum  UA  level of <5.0 mg/dl or <6.0 mg/dl at month 3 ( P  < 0.001 for all comparisons versus placebo). Equivalent doses of febuxostat  XR  and  IR  had similar treatment effects on serum  UA  level end points; however, a significantly greater proportion of patients achieved a serum  UA  level of <5.0 mg/dl with  XR  40 mg versus  IR  40 mg. Similar proportions of patients experienced ≥1 gout flare across treatment groups. Rates of treatment‐emergent adverse events were low and evenly distributed between treatment arms. A preplanned subgroup analysis demonstrated that febuxostat formulations were well tolerated and generally effective on serum  UA  level end points (versus placebo) across all renal function subgroups.    Conclusion  Both formulations of febuxostat ( XR  and  IR ) were well tolerated and effective in patients with gout and normal or impaired renal function, including patients with severe renal impairment.

Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase III Placebo‐Controlled Study