Renal safety and urate-lowering efficacy of febuxostat in gout patients with stage 4-5 chronic kidney disease not yet on dialysis.

Background/Aims: The safety and efficacy of febuxostat in patients with stage 4-5 chronic kidney disease (CKD) are still unclear owing to a lack of studies in these patients. Therefore, we aimed to evaluate the effect of febuxostat on renal function, general safety, and efficacy in gout patients with stage 4-5 CKD.

Methods: Among 739 patients who had been administered febuxostat from May 2012 to December 2016 at a single hospital in Korea, 370 patients who had been monitored for 1 year were analyzed. Serum uric acid levels and estimated glomerular filtration rate (eGFR) of patients with gouty arthritis were collected at baseline and 1 year after febuxostat administration.

Results: Among the 370 patients, 280 patients were stage 1-3 CKD, 63 patients were stage 4-5 CKD, and 27 patients were on dialysis. The eGFR of 63 patients with stage 4-5 CKD, excluding dialysis patients, was 19.84 ± 7.08 mL/min/1.73 m2 when they began to take febuxostat and 23.49 ± 16.67 mL/min/1.73 m2 after 12 months (p = 0.13). The urate-lowering effect after 12 months of febuxostat medication showed statistical significance (8.96 ± 2.31 mg/dL at baseline and 4.88 ± 1.68 mg/dL after 12 months, p < 0.01). The difference in incidence of adverse events among patients with stage 1-3 CKD, those with stage 4-5 CKD, and those on dialysis was not significant.

Conclusions: Febuxostat demonstrated renal safety and good urate-lowering efficacy in gout patients with stage 4-5 CKD, who are not yet on dialysis.