Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Kinoshita, Toshihiko, Takekita, Yoshiteru, Hiraoka, Shuichi, Tamura, Fumihiro, Iwama, Yasuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
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
_version_ 1785105024716636160
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
work_keys_str_mv AT kinoshitatoshihiko longtermsafetyandefficacyofsublingualasenapineforthetreatmentofschizophreniaaphaseiiiextensionstudywithfollowupfor52weeksp06125secondarypublication
AT takekitayoshiteru longtermsafetyandefficacyofsublingualasenapineforthetreatmentofschizophreniaaphaseiiiextensionstudywithfollowupfor52weeksp06125secondarypublication
AT hiraokashuichi longtermsafetyandefficacyofsublingualasenapineforthetreatmentofschizophreniaaphaseiiiextensionstudywithfollowupfor52weeksp06125secondarypublication
AT tamurafumihiro longtermsafetyandefficacyofsublingualasenapineforthetreatmentofschizophreniaaphaseiiiextensionstudywithfollowupfor52weeksp06125secondarypublication
AT iwamayasuhiro longtermsafetyandefficacyofsublingualasenapineforthetreatmentofschizophreniaaphaseiiiextensionstudywithfollowupfor52weeksp06125secondarypublication