論文

国際誌
2020年9月

Long-Term Safety and Effectiveness of the Xanthine Oxidoreductase Inhibitor, Topiroxostat in Japanese Hyperuricemic Patients with or Without Gout: A 54-week Open-label, Multicenter, Post-marketing Observational Study.

Clinical drug investigation
  • Tomohiko Ishikawa
  • ,
  • Tatsushi Maeda
  • ,
  • Teruo Hashimoto
  • ,
  • Tetsuya Nakagawa
  • ,
  • Kazuhito Ichikawa
  • ,
  • Yasushi Sato
  • ,
  • Yoshihiko Kanno

40
9
開始ページ
847
終了ページ
859
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s40261-020-00941-3

BACKGROUND AND OBJECTIVES: Topiroxostat, a selective xanthine oxidoreductase inhibitor, is used for the management of hyperuricemic patients with or without gout in Japan. Accumulating evidence has demonstrated the efficacy of topiroxostat for the treatment of hyperuricemia with or without gout. However, the safety and efficacy of topiroxostat in the clinical setting remain unclear, and there is little large-scale clinical evidence. We conducted a post-marketing observational study over 54 weeks. PATIENTS AND METHODS: Patients were centrally enrolled, and case report forms of 4491 patients were collected between April 2014 and March 2019 from 825 medical sites. RESULTS: Overall, 4329 patients were assessed for safety and 4253 patients for effectiveness. The overall incidence of adverse drug reactions was 6.95%, and the incidence rates of adverse drug reactions of gouty arthritis, hepatic dysfunction, and skin disorders, which are of special interest in this study, were 0.79%, 1.73%, and 0.95%, respectively. No case of serious gouty arthritis was observed. Serum urate levels decreased stably over time and showed a significant reduction rate at 54 weeks (21.19% ± 22.07%) and on the final visit (19.91% ± 23.35%) compared to the baseline. The rates for subjects who achieved serum uric acid levels ≤ 6.0 mg/dL at 18 and 54 weeks after administration were 43.80% and 48.28%, respectively. CONCLUSIONS: This study suggests that there is no particular concern about adverse drug reactions or the efficacy of topiroxostat for hyperuricemic patients with or without gout in a post-marketing setting in Japan.

リンク情報
DOI
https://doi.org/10.1007/s40261-020-00941-3
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/32621143
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452866
ID情報
  • DOI : 10.1007/s40261-020-00941-3
  • PubMed ID : 32621143
  • PubMed Central 記事ID : PMC7452866

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