• Naoyuki Kamatani, Kamatani Naoyuki, Shin Fujimori, Fujimori Shin, Toshikazu Hada, Hada Toshikazu, Tatsuo Hosoya, Hosoya Tatsuo, Kenjiro Kohri, Kohri Kenjiro, Toshitaka Nakamura, Nakamura Toshitaka, Takanori Ueda, Ueda Takanori, Tetsuya Yamamoto, Yamamoto Tetsuya, Hisashi Yamanaka, Yamanaka Hisashi, Yuji Matsuzawa, and Matsuzawa Yuji.
• Institute of Rheumatology, Tokyo Women's Medical University, Teikyo University, Tokyo, Japan. kamatani@msb.biglobe.ne.jp
• J Clin Rheumatol. 2011 Jun 1; 17 (4 Suppl 2): S44-9.

BackgroundAllopurinol 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.ObjectivesFebuxostat was administered to patients with hyperuricemia including gout in Japan to compare its efficacy and safety with those of allopurinol.MethodsThe 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.ConclusionsThese 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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