The Urate-lowering Efficacy and Safety of Febuxostat in Korean Patients with Gout
- Authors
- 박성환; 송영욱; 박원; 고은미; 유빈; 이수곤; 유대현; 이윤종; 김현아; 최효진; 김호연; 정형기
- Issue Date
- 2013
- Publisher
- 대한류마티스학회
- Keywords
- Gout; Febuxostat; Urate-lowering efficacy; Korean patients
- Citation
- 대한류마티스학회지, v.20, no.4, pp.223 - 230
- Journal Title
- 대한류마티스학회지
- Volume
- 20
- Number
- 4
- Start Page
- 223
- End Page
- 230
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/15771
- ISSN
- 2093-940X
- Abstract
- Objective. To compare the urate-lowering efficacy and the safety of febuxostat, allopurinol and placebo in Korean patients with gout for 4 weeks.
Methods. Subjects (n=182) with gout were randomized to febuxostat (40, 80, 120 mg), allopurinol 300 mg, or placebo group. The primary end point was the proportion of subjects whose serum urate concentration fell to less than 6.0 mg/dL after the 4-week treatment.
Results. The primary end point was reached at 25.7%, 80.0% and 83.3% of patients receiving 40, 80 and 120 mg of febuxostat, respectively, 58.3% of those receiving 300 mg of allopurinol and none of the placebo (p<0.001: each febuxostat dose or allopurinol group versus placebo group, p=0.0484 and p=0.0196: febuxostat 80 and 120 mg compared with allopurinol, respectively). The number and proportion of subjects who developed adverse events (AEs) were 13 subjects (37%), 14 (39%) and 18 (50%) in the febuxostat of 40, 80 and 120 mg group, respectively, 21 (57%) in the allopurinol 300 mg group and 17 (46%) in the placebo group. No statistically significant differences in the incidence rates of adverse events were observed between the groups. There was no significant difference in gout flare-up incidence.
Conclusion. Febuxostat, 80 mg or 120 mg, was more effective than allopurinol (300 mg) or placebo, when lowering the serum urate. The safety of febuxostat and allopurinol was comparable.
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