Both extended-release and immediate-release formulations of febuxostat have demonstrated efficacy and tolerability in individuals with gout and normal or impaired renal function, according to a study recently published in Arthritis & Rheumatology.

The study included 1790 individuals with gout and a history of normal or impaired renal function. Participants were randomly assigned to received immediate-release febuxostat 40 or 80 mg, extended-release febuxostat 40 or 80 mg, or placebo once per day in equal ratios. Serum urate less than 5.0 mg/dL or 6.0 mg/dL at the 3-month mark were achieved with both formulations of febuxostat vs placebo (P <.001). Similar treatment effects were achieved between equal doses of extended-release and immediate-release febuxostat, with the exception of 40 mg formulations, for which serum urate <5.0 mg/dL was achieved more successfully with extended release than with immediate release.

Experiencing at least 1 flare of gout was similar across all groups, and treatment-emergent adverse events were infrequent and comparable across groups as well. Febuxostat was effective on serum urate end points and was well tolerated across subgroups of renal function.


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This multicenter, phase 3, placebo-controlled study was double-blind and lasted for 3 months. The primary end point of the study was the number of patients experiencing serum urate less than 5.0 mg/dL at the 3-month mark, with secondary end points including serum urate less than 6.0 mg/dL at 3 months and at least 1 flare of gout after 3 months that required treatment.

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The study researchers conclude that “both formulations of febuxostat…were well tolerated and effective in patients with gout and normal or impaired renal function, including patients with severe renal impairment.”

This study was supported by Takeda Pharmaceuticals International, Inc. Please refer to reference for a complete list of authors’ disclosures.

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Reference

Saag KG, Becker MA, Whelton A, et al. Efficacy and safety of febuxostat extended and immediate release in patients with gout and renal impairment: Phase III placebo-controlled study [published online August 3, 2018]. Arthritis Rheumatol. doi: 10.1002/art.40685