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Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout
BACKGROUND AND OBJECTIVES: Topiroxostat—a novel selective xanthine oxidoreductase inhibitor—has been reported to reduce serum urate levels. The purpose of this study was to assess the efficacy and safety of long-term topiroxostat administration in Japanese hyperuricemic patients with or without gout...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267543/ https://www.ncbi.nlm.nih.gov/pubmed/30219951 http://dx.doi.org/10.1007/s40261-018-0699-0 |
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author | Hosoya, Tatsuo Ishikawa, Tomohiko Ogawa, Yoshimi Sakamoto, Ryusuke Ohashi, Tetsuo |
author_facet | Hosoya, Tatsuo Ishikawa, Tomohiko Ogawa, Yoshimi Sakamoto, Ryusuke Ohashi, Tetsuo |
author_sort | Hosoya, Tatsuo |
collection | PubMed |
description | BACKGROUND AND OBJECTIVES: Topiroxostat—a novel selective xanthine oxidoreductase inhibitor—has been reported to reduce serum urate levels. The purpose of this study was to assess the efficacy and safety of long-term topiroxostat administration in Japanese hyperuricemic patients with or without gout. METHODS: This multicenter, open-label study evaluated the efficacy and safety of long-term twice-daily oral topiroxostat administration in patients with or without gout. The initial topiroxostat dosage was 40–80 mg/day, and the maintenance dosage was 120 mg/day, which was increased to 240 mg/day at 40 mg increments if the serum urate level exceeded 6.0 mg/dL. RESULTS: Serum urate level, which was the primary endpoint, decreased stably over time and showed significant reduction on the final visit (38.44% ± 13.34%) compared with that at the baseline. Both urinary albumin/creatinine ratio and mean blood pressure significantly improved. The overall incidence rate of adverse drug reactions to topiroxostat was 67.8%; on the final visit, the rate of adverse drug reactions was 66.7% with 120 mg/day, 72.2% with 160 mg/day, 53.8% with ≥ 200 mg/day, and 100% with the other dosages. On the final visit, the incidence of gouty arthritis, for which a causal relationship with topiroxostat could not be ruled out, was 4.1% overall, 4.8% with 120 mg/day, 0% with 160 mg/day, and 7.7% with ≥ 200 mg/day. CONCLUSIONS: We verified the efficacy and safety of 58-week oral topiroxostat administration at stepwise increments to up to 240 mg/day. STUDY REGISTRATION: JAPIC CTI-101068. |
format | Online Article Text |
id | pubmed-6267543 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-62675432018-12-11 Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout Hosoya, Tatsuo Ishikawa, Tomohiko Ogawa, Yoshimi Sakamoto, Ryusuke Ohashi, Tetsuo Clin Drug Investig Original Research Article BACKGROUND AND OBJECTIVES: Topiroxostat—a novel selective xanthine oxidoreductase inhibitor—has been reported to reduce serum urate levels. The purpose of this study was to assess the efficacy and safety of long-term topiroxostat administration in Japanese hyperuricemic patients with or without gout. METHODS: This multicenter, open-label study evaluated the efficacy and safety of long-term twice-daily oral topiroxostat administration in patients with or without gout. The initial topiroxostat dosage was 40–80 mg/day, and the maintenance dosage was 120 mg/day, which was increased to 240 mg/day at 40 mg increments if the serum urate level exceeded 6.0 mg/dL. RESULTS: Serum urate level, which was the primary endpoint, decreased stably over time and showed significant reduction on the final visit (38.44% ± 13.34%) compared with that at the baseline. Both urinary albumin/creatinine ratio and mean blood pressure significantly improved. The overall incidence rate of adverse drug reactions to topiroxostat was 67.8%; on the final visit, the rate of adverse drug reactions was 66.7% with 120 mg/day, 72.2% with 160 mg/day, 53.8% with ≥ 200 mg/day, and 100% with the other dosages. On the final visit, the incidence of gouty arthritis, for which a causal relationship with topiroxostat could not be ruled out, was 4.1% overall, 4.8% with 120 mg/day, 0% with 160 mg/day, and 7.7% with ≥ 200 mg/day. CONCLUSIONS: We verified the efficacy and safety of 58-week oral topiroxostat administration at stepwise increments to up to 240 mg/day. STUDY REGISTRATION: JAPIC CTI-101068. Springer International Publishing 2018-09-15 2018 /pmc/articles/PMC6267543/ /pubmed/30219951 http://dx.doi.org/10.1007/s40261-018-0699-0 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Hosoya, Tatsuo Ishikawa, Tomohiko Ogawa, Yoshimi Sakamoto, Ryusuke Ohashi, Tetsuo Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title | Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title_full | Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title_fullStr | Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title_full_unstemmed | Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title_short | Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout |
title_sort | multicenter, open-label study of long-term topiroxostat (fyx-051) administration in japanese hyperuricemic patients with or without gout |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267543/ https://www.ncbi.nlm.nih.gov/pubmed/30219951 http://dx.doi.org/10.1007/s40261-018-0699-0 |
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