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Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication
After completion of a 6‐week double‐blind trial of asenapine sublingual tablets (10 or 20 mg/day) versus placebo in Asian patients with acute exacerbation of schizophrenia, including Japanese patients, this open‐label study evaluated the safety and efficacy of a 52‐week treatment with asenapine at f...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10496045/ https://www.ncbi.nlm.nih.gov/pubmed/37232002 http://dx.doi.org/10.1002/npr2.12342 |
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author | Kinoshita, Toshihiko Takekita, Yoshiteru Hiraoka, Shuichi Tamura, Fumihiro Iwama, Yasuhiro |
author_facet | Kinoshita, Toshihiko Takekita, Yoshiteru Hiraoka, Shuichi Tamura, Fumihiro Iwama, Yasuhiro |
author_sort | Kinoshita, Toshihiko |
collection | PubMed |
description | After completion of a 6‐week double‐blind trial of asenapine sublingual tablets (10 or 20 mg/day) versus placebo in Asian patients with acute exacerbation of schizophrenia, including Japanese patients, this open‐label study evaluated the safety and efficacy of a 52‐week treatment with asenapine at flexible doses. In 201 subjects, including 44 who had received placebo (P/A group) and 157 who had received asenapine (A/A group) in the feeder trial, adverse events occurred at rates of 90.9% and 85.4% and serious adverse events at rates of 11.4% and 20.4%, respectively. One patient in the P/A group died. No clinically significant abnormal measurements of body weight, body mass index, or glycated hemoglobin, fasting plasma glucose, insulin, and prolactin levels were observed. The sustained efficacy rate, as evaluated by the Positive and Negative Syndrome Scale total score and other measures, remained at approximately 50% between 6 and 12 months of treatment. These results suggest that long‐term treatment with asenapine is well tolerated and provides sustained efficacy. |
format | Online Article Text |
id | pubmed-10496045 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-104960452023-09-13 Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication Kinoshita, Toshihiko Takekita, Yoshiteru Hiraoka, Shuichi Tamura, Fumihiro Iwama, Yasuhiro Neuropsychopharmacol Rep Original Articles After completion of a 6‐week double‐blind trial of asenapine sublingual tablets (10 or 20 mg/day) versus placebo in Asian patients with acute exacerbation of schizophrenia, including Japanese patients, this open‐label study evaluated the safety and efficacy of a 52‐week treatment with asenapine at flexible doses. In 201 subjects, including 44 who had received placebo (P/A group) and 157 who had received asenapine (A/A group) in the feeder trial, adverse events occurred at rates of 90.9% and 85.4% and serious adverse events at rates of 11.4% and 20.4%, respectively. One patient in the P/A group died. No clinically significant abnormal measurements of body weight, body mass index, or glycated hemoglobin, fasting plasma glucose, insulin, and prolactin levels were observed. The sustained efficacy rate, as evaluated by the Positive and Negative Syndrome Scale total score and other measures, remained at approximately 50% between 6 and 12 months of treatment. These results suggest that long‐term treatment with asenapine is well tolerated and provides sustained efficacy. John Wiley and Sons Inc. 2023-05-25 /pmc/articles/PMC10496045/ /pubmed/37232002 http://dx.doi.org/10.1002/npr2.12342 Text en © 2023 The Authors. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsychopharmacology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Kinoshita, Toshihiko Takekita, Yoshiteru Hiraoka, Shuichi Tamura, Fumihiro Iwama, Yasuhiro Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title | Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title_full | Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title_fullStr | Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title_full_unstemmed | Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title_short | Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication |
title_sort | long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: a phase iii extension study with follow‐up for 52 weeks (p06125)—secondary publication |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10496045/ https://www.ncbi.nlm.nih.gov/pubmed/37232002 http://dx.doi.org/10.1002/npr2.12342 |
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