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The Effect of Mild and Moderate Hepatic Impairment on Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat, a Novel Nonpurine Selective Inhibitor of Xanthine Oxidase

From TAP Pharmaceutical Products Inc, Lake Forest, Illinois. All authors are employees of TAP Pharmaceutical Products Inc.

To assess the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, and safety of febuxostat at steady state, multiple once-daily 80-mg oral doses of febuxostat were administered to subjects with normal hepatic function and to subjects with mild or moderate hepatic impairment. There were no statistically significant differences in the plasma pharmacokinetic parameters for unbound febuxostat and its active metabolites between subjects with mild or moderate hepatic impairment and those with normal hepatic function. The percentage decrease in serum uric acid appeared to be lower in hepatic impairment groups (49% [mild] and 48% [moderate]) as compared to the normal hepatic group (62%). This lower percentage decrease was minimal and not considered clinically significant. Febuxostat 80 mg once daily appears to be generally safe and well tolerated in mildly and moderately impaired hepatic function groups, and dose adjustment is not required in subjects with mild to moderate hepatic impairment.

Key Words: Febuxostat • pharmacokinetics • pharmacodynamics • xanthine oxidase • hepatic impairment

Address for reprints: Reza Khosravan, PhD, Department of Drug Metabolism and Pharmacokinetics, TAP Pharmaceutical Products Inc, 675 North Field Drive, Lake Forest, IL 60045.

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