An allopurinol-controlled, multicenter, randomized, open-label, parallel
between-group, comparative study of febuxostat (TMX-67), a non-purine-selective
inhibitor of xanthine oxidase, in patients with hyperuricemia including those
with gout in Japan: phase 2 exploratory clinical study.
Author(s): Naoyuki K, Shin F, Toshikazu H, Tatsuo H, Kenjiro K, Toshitaka N, Takanori U,
Tetsuya Y, Hisashi Y, Yuji M.
Affiliation(s): Institute of Rheumatology, Tokyo Women's Medical University, Teikyo University,
Tokyo, Japan. kamatani@msb.biglobe.ne.jp
Publication date & source: 2011, J Clin Rheumatol. , 17(4 Suppl 2):S44-9
BACKGROUND: Allopurinol has been widely used for the treatment of hyperuricemia,
however, it may be associated with various adverse effects. Febuxostat has been
identified as a potentially safe and efficacious alternative.
OBJECTIVES: Febuxostat was administered to patients with hyperuricemia including
gout in Japan to compare its efficacy and safety with those of allopurinol.
METHODS: The starting dose of febuxostat and allopurinol was 10 and 100 mg/d,
respectively, and was increased to the fixed maintenance dose of 40 or 60 mg/d
for febuxostat and 300 mg/d for allopurinol for 16 weeks.
RESULTS: : The percent change in the serum uric acid level at 16 weeks compared
with the baseline serum uric acid level was -42.96% ± 13.33% and -52.47% ± 9.79%
for the febuxostat 40- and 60-mg/d groups, respectively, and -36.55% ± 18.59% for
the allopurinol group, indicating that the hypouricemic effects of febuxostat
increased in a dose-dependent manner and equaled to or surpassed those of
allopurinol (P = 0.0239, 2-sample t test). The percentage of patients with serum
uric acid levels of 6.0 mg/dL or less at 16 weeks was 88.9% and 100% for the
febuxostat 40- and 60-mg/d groups, respectively, and 68.8% for the allopurinol
group, showing higher achievements for the febuxostat groups compared with the
allopurinol group. All adverse drug reactions were mild to moderate in severity,
and there were no severe symptoms or reactions leading to drug discontinuation.
CONCLUSIONS: These results suggest that febuxostat is safe at doses of 40 and 60
mg/d and has equal or greater efficacy than 300 mg/d allopurinol.
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