The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia

Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Akihide Wakamatsu,2 Ai Tanimura,3 Kazuo Morita,3 Toshio Yamaoka,3 Hideo Usui,3 Yoshimasa Ogawa,3 Akiko Fujino,3 Kazutake Yoshizawa11Evidence Generation Department, Medical Affairs Division, 2Medical Affairs Strategy Department, Medical Affairs...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Nakagawa R, Ohnishi T, Kobayashi H, Wakamatsu A, Tanimura A, Morita K, Yamaoka T, Usui H, Ogawa Y, Fujino A, Yoshizawa K
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/a45c28c98e154f0994bcd839e9058c61
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a45c28c98e154f0994bcd839e9058c61
record_format	dspace
spelling	oai:doaj.org-article:a45c28c98e154f0994bcd839e9058c612021-12-02T05:52:27ZThe social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia1178-2021https://doaj.org/article/a45c28c98e154f0994bcd839e9058c612015-06-01T00:00:00Zhttp://www.dovepress.com/the-social-functional-outcome-of-being-naturalistically-treated-with-p-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Akihide Wakamatsu,2 Ai Tanimura,3 Kazuo Morita,3 Toshio Yamaoka,3 Hideo Usui,3 Yoshimasa Ogawa,3 Akiko Fujino,3 Kazutake Yoshizawa11Evidence Generation Department, Medical Affairs Division, 2Medical Affairs Strategy Department, Medical Affairs Division, 3Drug Safety Surveillance Department, Japan Safety and Surveillance Division, Janssen Pharmaceutical K.K., Tokyo, JapanBackground: Social functioning is an important outcome for patients with schizophrenia. To evaluate the effects of paliperidone extended-release (PAL-ER) on social function, symptomatology, and safety in the routine clinical practice, we conducted a 1-year post-marketing surveillance study of PAL-ER. We also explored relationships between symptomatic improvement and socially functional outcome in patients with schizophrenia.Patients and methods: Patients with an established diagnosis of schizophrenia were allowed flexible 3–12 mg/day dosing during the surveillance. Patients were assessed on social functioning using the Social and Occupational Functioning Assessment Scale (SOFAS) and on symptomatology using the Clinical Global Impression–Schizophrenia scale. All adverse events (AEs) were also collected.Results: A total of 1,429 patients were enrolled in the surveillance study, of whom 1,405 were evaluable for safety and 1,142 were evaluable for efficacy. The treatment discontinuation rate for any reason during the observation period was 34.66%. Significant improvements were observed on both Social and Occupational Functioning Assessment Scale and Clinical Global Impression–Schizophrenia scale during the observation period. The percentage of patients with socially functional remission (SOFAS ≥61) also increased significantly. A significant association between early improvements in positive symptoms, sex, severity of negative symptoms at baseline, and socially functional remission was observed. A total of 33.52% of patients had AEs and 8.75% of patients had serious AEs. Despite the recommendation of monotherapy with PAL-ER, 65.84% of patients were given additional antipsychotics (polypharmacy). Post hoc comparisons of monotherapy versus polypharmacy revealed that the monotherapy group had better outcomes and fewer AEs than the polypharmacy treated group. The improvement in social functioning and the rate of socially functional remission did not differ between groups.Conclusion: PAL-ER treatment showed effective symptom control and improvement in social functioning. The data suggest that early response to antipsychotic treatment should be important for functional outcomes.Keywords: paliperidone, social function, schizophrenia, naturalistic studyNakagawa ROhnishi TKobayashi HWakamatsu ATanimura AMorita KYamaoka TUsui HOgawa YFujino AYoshizawa KDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2015, Iss default, Pp 1511-1521 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Nakagawa R Ohnishi T Kobayashi H Wakamatsu A Tanimura A Morita K Yamaoka T Usui H Ogawa Y Fujino A Yoshizawa K The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
description	Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Akihide Wakamatsu,2 Ai Tanimura,3 Kazuo Morita,3 Toshio Yamaoka,3 Hideo Usui,3 Yoshimasa Ogawa,3 Akiko Fujino,3 Kazutake Yoshizawa11Evidence Generation Department, Medical Affairs Division, 2Medical Affairs Strategy Department, Medical Affairs Division, 3Drug Safety Surveillance Department, Japan Safety and Surveillance Division, Janssen Pharmaceutical K.K., Tokyo, JapanBackground: Social functioning is an important outcome for patients with schizophrenia. To evaluate the effects of paliperidone extended-release (PAL-ER) on social function, symptomatology, and safety in the routine clinical practice, we conducted a 1-year post-marketing surveillance study of PAL-ER. We also explored relationships between symptomatic improvement and socially functional outcome in patients with schizophrenia.Patients and methods: Patients with an established diagnosis of schizophrenia were allowed flexible 3–12 mg/day dosing during the surveillance. Patients were assessed on social functioning using the Social and Occupational Functioning Assessment Scale (SOFAS) and on symptomatology using the Clinical Global Impression–Schizophrenia scale. All adverse events (AEs) were also collected.Results: A total of 1,429 patients were enrolled in the surveillance study, of whom 1,405 were evaluable for safety and 1,142 were evaluable for efficacy. The treatment discontinuation rate for any reason during the observation period was 34.66%. Significant improvements were observed on both Social and Occupational Functioning Assessment Scale and Clinical Global Impression–Schizophrenia scale during the observation period. The percentage of patients with socially functional remission (SOFAS ≥61) also increased significantly. A significant association between early improvements in positive symptoms, sex, severity of negative symptoms at baseline, and socially functional remission was observed. A total of 33.52% of patients had AEs and 8.75% of patients had serious AEs. Despite the recommendation of monotherapy with PAL-ER, 65.84% of patients were given additional antipsychotics (polypharmacy). Post hoc comparisons of monotherapy versus polypharmacy revealed that the monotherapy group had better outcomes and fewer AEs than the polypharmacy treated group. The improvement in social functioning and the rate of socially functional remission did not differ between groups.Conclusion: PAL-ER treatment showed effective symptom control and improvement in social functioning. The data suggest that early response to antipsychotic treatment should be important for functional outcomes.Keywords: paliperidone, social function, schizophrenia, naturalistic study
format	article
author	Nakagawa R Ohnishi T Kobayashi H Wakamatsu A Tanimura A Morita K Yamaoka T Usui H Ogawa Y Fujino A Yoshizawa K
author_facet	Nakagawa R Ohnishi T Kobayashi H Wakamatsu A Tanimura A Morita K Yamaoka T Usui H Ogawa Y Fujino A Yoshizawa K
author_sort	Nakagawa R
title	The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
title_short	The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
title_full	The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
title_fullStr	The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
title_full_unstemmed	The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
title_sort	social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/a45c28c98e154f0994bcd839e9058c61
work_keys_str_mv	AT nakagawar thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT ohnishit thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT kobayashih thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT wakamatsua thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT tanimuraa thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT moritak thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT yamaokat thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT usuih thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT ogaway thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT fujinoa thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT yoshizawak thesocialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT nakagawar socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT ohnishit socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT kobayashih socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT wakamatsua socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT tanimuraa socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT moritak socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT yamaokat socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT usuih socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT ogaway socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT fujinoa socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia AT yoshizawak socialfunctionaloutcomeofbeingnaturalisticallytreatedwithpaliperidoneextendedreleaseinpatientswithschizophrenia
_version_	1718400188463185920

The social functional outcome of being naturalistically treated with paliperidone extended-release in patients with schizophrenia

Ejemplares similares