Effects of febuxostat on serum urate level in Japanese hyperuricemia patients

Abstract

Objective. We assessed the efficacy and adverse effects of febuxostat in male hyperuricemia patients. Subjects and methods. This was a 12-week, multicenter, open-label, uncontrolled study. The enrolled subjects were 89 hyperuricemic male patients (12 overexcretors, 56 normal excretors, and 21 underexcretors). The endpoint was percent change in serum urate level. Results. The concentration of urate in serum before and 12 weeks after beginning administration of febuxostat in the overexcretors was 9.34 ± 1.48 and 5.59 ± 1.17 mg/dl, respectively, while those were 8.59 ± 1.24 and 5.41 ± 1.35 mg/dl, respectively, in the normal excretors, and 8.29 ± 1.01and 5.11 ± 1.71 mg/dl, respectively, in the underexcretors. After 12 weeks, the rate of change in serum urate after beginning administration of febuxostat was − 0.384 ± 0.186 in the overexcretors, − 0.368 ± 0.128 in the normal excretors, and − 0.365 ± 0.217 in the underexcretors, with no significant differences among them. A common adverse event related to febuxostat was gout flare. Conclusion. Febuxostat effectively reduced the concentration of urate in serum in hyperuricemic patients regardless of the level of uric acid excreted in urine without severe adverse effects.

Keywords:

• Febuxostat
• Gout
• Gout flare
• Hyperuricemia
• Uric acid

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Corrigendum

Conflicts of interest

T. Yamamoto received lecture honorariums from Teijin Pharma, Sanwa, and GlaxoSmithKline.

M. Inaba received research funding from Asahikasei Pharma, Astellas, Baieru, Chugai, Daiichi-Sankyo, Eisai, Eli-Lilly Japan, Kyowa Kirin, Kyowa Medics, Takeda, Teijin Pharma, Mitsubishi-Tanabe, and Teijin; and served on speaker bureaus for Asahikasei Pharma, Baieru, Chugai, Daiichi-Sankyo, Kyowa Kirin, Mitsubishi-Tanabe, MSD, Ono, Taisho-Toyama, Takeda, and Teijin Pharma.

Y. Moriwaki received research funding from Asahikasei, Astellas, AstraZeneca, MSD, Otsuka, Kaken, Kyowa Kirin, GlaxoSmithKline, Sanfi, Shionogi, Sumitomo Dainippon, Takeda, Mitsubishi-Tanabe, Teijin Pharma, Torii, Pfizer, Mochida, Novartis, and Boehringer-Ingelhaim; and served on speaker bureaus for Teijin Pharma and Sanwa.

T. Hosoya served on speaker bureaus for Teijin Pharma and Sanwa.

A. Ohtawara received lecture honorariums from Teijin Pharma and Sanwa.

H. Kakuta received a lecture honorarium from Teijin Pharma.

A. Taniguchi received research grants from Takeda and Pfizer and received lecture honorariums from Teijin Pharma, Torii, Abbie, and Eisai.

T. Ueda received research funding from Chugai, Torii, Japan Blood Products Organization, Bristol Myers, Novartis, Kyowa Kirin, Nippon Shinyaku, Asahikasei Pharma, Teijin, Astellas, Eizai, MSD, Alexion, Pfizer, Fujifilm, Sumitomo Dainippon, Shionogi, and Takeda; and received lecture or consultancy honorariums from Teijin, MSD, Novartis Pharma, Janssen Pharma, Sumitomo Dainippon, Fujifilm, Lexion, Kyowa Kirin, Celgene, Chugai, Astellas, Eli Lilly Japan, Asahikasei Pharma, Daiichi Sankyo, and Eizai.

S. Fujimori received lecture or consultancy honorariums from Teijin Pharma, Astellas, Fujiyakuhin, Sanwa, Takeda, Chemiphar, and Kissei.

H. Yamanaka received research grants from AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, and Teijin Pharma; and received honorarium for the lecture or consultancy from Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB.

The other authors have no conflicts of interest declare.

The present study was financially supported by Teijin Pharma, Japan.

Notice of correction: The publisher regrets that the initial version of this article published online on 12 March 2015 contained errors. In Table 1 the values for the number of gout patients and the number of patients with asymptomatic hyperuricemia were transposed. In addition, in the Results section under the heading “Estimated glomerular filtration rate”, the text “eGFR was increased from 74 ± 14 mml/min at baseline (n = 46) to 77 ± 14 mmHg” should have read “eGFR was increased from 74 ± 14 ml/min at baseline (n = 46) to 77 ± 14 ml/min”. These errors have been corrected in the current version.