The efficacy and safety of benzbromarone and febuxostat in combined-type hyperuricemia: a single-center study.

objectivesTo explore the short-term urate-lowering efficacy and safety of benzbromarone versus febuxostat in patients with combined-type hyperuricemia.

methodsThis retrospective study included treatment-naïve adults with combined-type hyperuricemia (24-h urinary uric acid > 600 mg/24h and fractional excretion of uric acid < 5.5%) who initiated benzbromarone (25 mg/day) or febuxostat (20 mg/day). The primary endpoint was the proportion achieving serum urate (SUA) < 360 µmol/L at 4 weeks. Secondary endpoints included absolute SUA reduction and safety. Multivariable logistic and Cox regression models were performed with the adjustment of baseline SUA, estimated glomerular filtration rate (eGFR), and concomitant sodium bicarbonate use.

results104 males were enrolled (benzbromarone 49, febuxostat 55). The unadjusted 4-week target achievement rate was higher with benzbromarone (53.1% vs. 27.3%, p = 0.013). After multivariable adjustment, this difference was no longer significant (adjusted OR 2.20, 95% CI 0.88-5.46; p = 0.090). Sodium bicarbonate use was more frequent with benzbromarone (63.3% vs. 32.7%, p = 0.004) and was associated with target attainment (adjusted OR 2.46, p = 0.048). Among 66 patients with extended follow-up, the between-group difference attenuated over time, with comparable cumulative rates by week 12 (84.4% vs. 73.5%, p = 0.438). Both treatments were well tolerated without serious adverse events (SAEs) reported.

conclusionBenzbromarone and febuxostat demonstrated different early serum urate target attainment rates at 4 weeks, with a numerically higher unadjusted rate observed in the benzbromarone group that was attenuated and no longer statistically significant after multivariable adjustment. Cumulative target achievement converged over time among patients with extended follow-up. These findings require confirmation in prospective studies with extended follow-up to evaluate long-term clinical outcomes. Key Points • Low-dose benzbromarone showed a numerically higher 4-week serum urate target attainment rate than febuxostat, although this difference was not statistically significant after adjustment for confounders. • Concomitant sodium bicarbonate use was associated with earlier serum urate target attainment, although this association may reflect both the potential contribution of urinary alkalinization and treatment-selection patterns in routine clinical practice. • Cumulative target achievement rates converged by week 12, suggesting comparable sustained efficacy with continued therapy. • Both treatments were well tolerated, with no serious adverse events reported over 12 weeks.