Background/Purpose:  Febuxostat has shown to be effective and safe in the treatment of hyperuricemia in patients with mild-to-moderate renal impairment without dose adjustment. However, there are insufficient data for the use of febuxostat in patients with severe renal impairment or hemodialysis. We investigated the efficacy and tolerability of febuxostat in patients with hyperuricemia and severe renal impairment (chronic kidney disease, stage 4 or 5).

Methods:  We retrospectively reviewed clinical and laboratory data from a tertiary hospital from 2012 to 2015. We included 57 patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²) who had been treated with febuxostat. Data regarding serum uric acid and serum creatinine level before and after the start of febuxostat treatment, and clinical information including adverse events were obtained from medical records. The paired t-test was used to determine statistical significance of the effect of febuxostat on serum uric acid levels.

Results: Among 57 patients, there were 46 men (81%) and 11 women (19%). Mean age was 57.8±13.7 years (range, 28-79). Before the start of febuxostat treatment, mean serum uric acid level was 9.2±1.9 mg/dL (range, 5.6-16.4), and mean creatinine level was 4.2±2.4 mg/dL (mean eGFR 18.6±7.6 mL/min/1.73m²; range, 3.0-29.7). Mean daily doses of febuxostat and median duration of follow-up under treatment were 54±23 mg (range, 40-160) and 15 months (range, 2-38 months), respectively. Twenty-one patients (36.8%) were on dialysis. Under treatment with febuxostat, serum uric acid levels were significanly reduced at 3 months: Mean reduction of serum uric acid levels was 5.64±3.09 mg/dL (p<0.001) in patients on dialysis and 3.81±2.24 (p<0.001) in patients not on dialysis; Eighteen of 20 patients (90%) on dialysis and 26 of 36 patients (72.2%) not on dialysis achieved a target serum uric acid level ≤6.0mg/dL. In one patient, febuxostat was stopped because of skin itching and generalized edema. In most patients (98%), febuxostat was well tolerated without withdrawals due to side effects.

Conclusion: This study showed that febuxostat was efficacious and was well tolerated in hyperuricemic patients with severe renal impairment undergoing or not undergoing dialysis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-efficacy-and-tolerability-of-febuxostat-in-hyperuricemic-patients-with-severe-renal-impairment/