Effects, safety, and plasma levels of topiroxostat and its metabolites in patients receiving hemodialysis

BackgroundSerum uric acid concentrations have been associated with mortality in patients receiving hemodialysis. Treatment options are sometimes limited because of the accumulation of a drug and/or its metabolites. The aim of the present study is to investigate the efficacy, safety, and plasma levels of topiroxostat, a selective xanthine oxidase inhibitor, and its metabolites in patients receiving hemodialysis.MethodsThis was a 52-week open study. The plasma concentrations of topiroxostat and its metabolites were measured. The endpoints selected were effects on serum uric acid concentrations and the safety and tolerability of topiroxostat. A statistical analysis was performed using a paired t test with Bonferroni corrections.ResultsNineteen participants were followed for 52 weeks without significant adverse effects. Serum uric acid concentrations decreased from 527 ± 49 to 325 ± 62, 297 ± 99, 297 ± 68, and 296 ± 83 μmol/L (weeks 4, 12, 26, and 52; p