An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia.
OBJECTIVE
Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia.


METHODS
Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements.


RESULTS
The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups.


CONCLUSIONS
The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested.
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xinfang
X
Huang
Hui
H
Du
Jieruo
J
Gu
Dongbao
D
Zhao
Lindi
L
Jiang
Xinfu
X
Li
Xiaoxia
X
Zuo
Yi
Y
Liu
Zhanguo
Z
Li
Xiangpei
X
Li
Ping
P
Zhu
Juan
J
Li
Zhiyi
Z
Zhang
Anbin
A
Huang
Yuanchao
Y
Zhang
Chunde
C
Bao
D000328:Adult; D000493:Allopurinol / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002681:China; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000069465:Febuxostat; D005260:Female; D006073:Gout / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000201:enzymology; D006074:Gout Suppressants / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D033461:Hyperuricemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood; D014969:Xanthine Oxidase / Q000037:antagonists & inhibitors* / Q000378:metabolism
D015415:Biomarkers; D004791:Enzyme Inhibitors; D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat; D014527:Uric Acid; D000493:Allopurinol; D014969:Xanthine Oxidase
allopurinol; febuxostat; gout; hyperuricemia