| 초록 |
Background: The aim of this 12-week, open-label, non-inferiority trial was to compare the safety and efficacy of febuxostat with allopurinol in treating chronic gout patients with chronic kidney disease (CKD).
Methods: Patients were randomized to febuxostat (n= 53; 40mg daily for the first 4 weeks, 80mg thereafter) or allopurinol (n=53; dose adjusted based on ones kidney function), and both groups were stratified by baseline serum uric acid (SUA) 10.0 mg/dL. SUA was checked for 4 times (week2, 4, 8, 12) The primary end point was the proportion of SUA below 6.0 mg/dL at the end of the study. The non-inferiority margin for the difference in rates (of SUA below 6.0 mg/dL) was defined as -15 %. Efficacy analyses were done both by intention-to-treat (ITT) and per protocol (PP).
Results: Uric acid control with febuxostat (n= 49, 94.2 %) was non-inferior to that achieved with allopurinol (n= 13, 26 %), difference 0.68 [97.5 % CI 0.54 to ∞]. The proportion of SUA below 6.0 mg/dL at week 2 was 57.69 % (febuxostat) and 12% (allopurinol), respectively. And the rate increased in both group to 94.23 % (febuxostat), 26 % (allopurinol) at week 12 (p<0.0001). The rate of GFR change or incidence of AKI had no difference in both group. Skin eruption was observed in 1 case with allopurinol, but was tolerable.
Conclusion: Febuxostat was as effective as allopurinol in reducing SUA in chronic gout patients with CKD, with a similar safety profile.
Table: Table 1. Baseline characteristics of the participants |