J Rheum Dis.  2013 Aug;20(4):223-230. 10.4078/jrd.2013.20.4.223.

The Urate-lowering Efficacy and Safety of Febuxostat in Korean Patients with Gout

• Park SH
• Song YW
• Park W
• Koh EM
• Yoo B
• Lee SK
• Yoo DH
• Lee YJ
• Kim HA
• Choi HJ
• Kim HY
• Jung HG

• KMID: 2297536
• DOI: http://doi.org/10.4078/jrd.2013.20.4.223

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.

Keyword

Gout; Febuxostat; Urate-lowering efficacy; Korean patients

MeSH Terms

Allopurinol
Gout
Humans
Incidence
Thiazoles
Uric Acid
Febuxostat
Allopurinol
Thiazoles
Uric Acid

Figure

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  Figure 1. Flow chart of the patient allocation.

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  Figure 2. The proportions of subjects with serum urate levels falling to <6.0 mg/dL after the 4-week treatment. ∗p<0.0001 vs. placebo, Febuxostat 40 mg, 80 mg, 120 mg vs. allopurinol, p=0.0054, 0.0484, 0.0196 respectively. p-value by Fisher's exact test or chi-square test.

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  Figure 3. The frequency of subjects with gout flare-up. There were no significant differences in the incidence of gout flare-up between the groups during the treatment period (p>0.05).

Reference

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