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KMID : 0388220130200040223
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Journal of the Korean Rheumatism Association
2013 Volume.20 No. 4 p.223 ~ p.230
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The Urate-lowering Efficacy and Safety of Febuxostat in Korean Patients with Gout
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Park Sung-Hwan
Song Yeong-Wook
Park Won
Koh Eun-Mi
Yoo Bin
Lee Soo-Kon
Yoo Dae-Hyun
Lee Yun-Jong
Kim Hyun-Ah
Choi Hyo-Jin
Kim Ho-Youn
Jung Hyoung-Ki
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Abstract
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Objective. To compare the urate-lowering efficacy and the safety of febuxostat, allopurinol and placebo in Korean pa-tients 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 sub-jects 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 fe-buxostat 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 sub-jects (37%), 14 (39%) and 18 (50%) in the febuxostat of 40, 80 and 120 mg group, respectively, 21 (57%) in the allopur-inol 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 effec-tive than allopurinol (300 mg) or placebo, when lowering the serum urate. The safety of febuxostat and allopurinol was comparable.
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KEYWORD
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Gout, Febuxostat, Urate-lowering efficacy, Korean patients
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