Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression

Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression

Masaki Kato,1 Toshifumi Kimura,2 Takeshi Kimura,3 Terufumi Hara3 1Department of Neuropsychiatry, Kansai Medical University, Moriguchi-shi, Osaka, Japan; 2Medical Affairs, 3Clinical Safety and PMS, Development and Medical Affairs Division, GlaxoSmithKline K.K., Shibuya-ku, Tokyo, Japan Objective:...

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Autores principales: Kato M, Kimura T, Hara T
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/ee88181ec17b4414a31679391cedc50e
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spelling oai:doaj.org-article:ee88181ec17b4414a31679391cedc50e2021-12-02T03:19:15ZSafety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression1178-2021https://doaj.org/article/ee88181ec17b4414a31679391cedc50e2015-02-01T00:00:00Zhttp://www.dovepress.com/safety-and-effectiveness-of-controlled-release-paroxetine-in-routine-c-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021 Masaki Kato,1 Toshifumi Kimura,2 Takeshi Kimura,3 Terufumi Hara3 1Department of Neuropsychiatry, Kansai Medical University, Moriguchi-shi, Osaka, Japan; 2Medical Affairs, 3Clinical Safety and PMS, Development and Medical Affairs Division, GlaxoSmithKline K.K., Shibuya-ku, Tokyo, Japan Objective: Selective serotonin reuptake inhibitors are commonly used in the pharmacotherapy of depression. However, adverse events can lead to their early discontinuation. This study evaluated the safety and effectiveness of paroxetine controlled-release (CR) tablets in Japanese patients with depression/depressive state (hereafter referred to as depression) in routine clinical practice in Japan. Patients and methods: This was an open-label, noninterventional, prospective, postmarketing surveillance study. A total of 3,213 patients aged 12–92 years with depression were prescribed paroxetine CR for 8 weeks at the physician’s discretion. Safety was evaluated on the basis of the reporting of adverse drug reactions. Effectiveness was evaluated on the basis of the physician’s assessment using the Clinical Global Impression-Global Improvement (CGI-GI) and the Clinical Global Impression-Severity of Illness (CGI-SI) scales, as well as on the basis of the patients’ self-reported satisfaction. The primary effectiveness outcome was the improvement rate based on the physician’s assessment using the CGI-GI. Results: The incidence of adverse drug reactions was 11.2% (359/3,213; 95% confidence interval [CI]: 10.1%–12.3%). The common adverse drug reactions that accounted for 1.0% or more of the incidence were nausea (3.5%) and somnolence (2.7%). The proportion of patients who continued paroxetine CR at week 8 was 80.2% (2,577/3,213; 95% CI: 78.8%–81.6%). The improvement rate at week 8 (last observation carried forward) was 72.8% (2,132/2,927; 95% CI: 71.2%–74.4%). The proportion of patients with CGI-SI scores of moderately or severely ill decreased from 63.6% at baseline to 17.9% at week 8. The proportion of patients who were satisfied with paroxetine CR treatment was 69.8% (2,040/2,921; 95% CI: 68.1%–71.5%). Conclusion: The results of this study suggest that paroxetine CR is a well-tolerated and efficacious treatment for depression in routine clinical practice. Keywords: paroxetine, controlled-release, postmarketing surveillance, depressionKato MKimura TKimura THara TDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2015, Iss default, Pp 435-452 (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
Kato M
Kimura T
Kimura T
Hara T
Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
description Masaki Kato,1 Toshifumi Kimura,2 Takeshi Kimura,3 Terufumi Hara3 1Department of Neuropsychiatry, Kansai Medical University, Moriguchi-shi, Osaka, Japan; 2Medical Affairs, 3Clinical Safety and PMS, Development and Medical Affairs Division, GlaxoSmithKline K.K., Shibuya-ku, Tokyo, Japan Objective: Selective serotonin reuptake inhibitors are commonly used in the pharmacotherapy of depression. However, adverse events can lead to their early discontinuation. This study evaluated the safety and effectiveness of paroxetine controlled-release (CR) tablets in Japanese patients with depression/depressive state (hereafter referred to as depression) in routine clinical practice in Japan. Patients and methods: This was an open-label, noninterventional, prospective, postmarketing surveillance study. A total of 3,213 patients aged 12–92 years with depression were prescribed paroxetine CR for 8 weeks at the physician’s discretion. Safety was evaluated on the basis of the reporting of adverse drug reactions. Effectiveness was evaluated on the basis of the physician’s assessment using the Clinical Global Impression-Global Improvement (CGI-GI) and the Clinical Global Impression-Severity of Illness (CGI-SI) scales, as well as on the basis of the patients’ self-reported satisfaction. The primary effectiveness outcome was the improvement rate based on the physician’s assessment using the CGI-GI. Results: The incidence of adverse drug reactions was 11.2% (359/3,213; 95% confidence interval [CI]: 10.1%–12.3%). The common adverse drug reactions that accounted for 1.0% or more of the incidence were nausea (3.5%) and somnolence (2.7%). The proportion of patients who continued paroxetine CR at week 8 was 80.2% (2,577/3,213; 95% CI: 78.8%–81.6%). The improvement rate at week 8 (last observation carried forward) was 72.8% (2,132/2,927; 95% CI: 71.2%–74.4%). The proportion of patients with CGI-SI scores of moderately or severely ill decreased from 63.6% at baseline to 17.9% at week 8. The proportion of patients who were satisfied with paroxetine CR treatment was 69.8% (2,040/2,921; 95% CI: 68.1%–71.5%). Conclusion: The results of this study suggest that paroxetine CR is a well-tolerated and efficacious treatment for depression in routine clinical practice. Keywords: paroxetine, controlled-release, postmarketing surveillance, depression
format article
author Kato M
Kimura T
Kimura T
Hara T
author_facet Kato M
Kimura T
Kimura T
Hara T
author_sort Kato M
title Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
title_short Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
title_full Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
title_fullStr Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
title_full_unstemmed Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
title_sort safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression
publisher Dove Medical Press
publishDate 2015
url https://doaj.org/article/ee88181ec17b4414a31679391cedc50e
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