Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

Takeshi Terao,1 Atsuko Ishida,2 Toshifumi Kimura,3 Mitsuhiro Yoshida,4 Terufumi Hara2 1Department of Neuropsychiatry, Faculty of Medicine, Oita University, Oita, 2Post-Marketing Surveillance Department, 3MA Specialty & General Care Medicine Department, 4Biomedical Data Sciences Department,...

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Autores principales:	Terao T, Ishida A, Kimura T, Yoshida M, Hara T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	lamotrigine bipolar mood episode post-marketing surveillance study safety efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/f18039b371494520ad7a26f6a32755fb
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spelling	oai:doaj.org-article:f18039b371494520ad7a26f6a32755fb2021-12-02T03:01:46ZAssessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report1178-2021https://doaj.org/article/f18039b371494520ad7a26f6a32755fb2017-06-01T00:00:00Zhttps://www.dovepress.com/assessment-of-safety-and-efficacy-of-lamotrigine-over-the-course-of-1--peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Takeshi Terao,1 Atsuko Ishida,2 Toshifumi Kimura,3 Mitsuhiro Yoshida,4 Terufumi Hara2 1Department of Neuropsychiatry, Faculty of Medicine, Oita University, Oita, 2Post-Marketing Surveillance Department, 3MA Specialty & General Care Medicine Department, 4Biomedical Data Sciences Department, Development & Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan Background: A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD).Patients and methods: Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation.Results: A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment.Conclusion: The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. Keywords: lamotrigine, bipolar, mood episode, post-marketing surveillance study, safety, efficacyTerao TIshida AKimura TYoshida MHara TDove Medical Pressarticlelamotriginebipolarmood episodepost-marketing surveillance studysafetyefficacyNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 1441-1448 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	lamotrigine bipolar mood episode post-marketing surveillance study safety efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	lamotrigine bipolar mood episode post-marketing surveillance study safety efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Terao T Ishida A Kimura T Yoshida M Hara T Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
description	Takeshi Terao,1 Atsuko Ishida,2 Toshifumi Kimura,3 Mitsuhiro Yoshida,4 Terufumi Hara2 1Department of Neuropsychiatry, Faculty of Medicine, Oita University, Oita, 2Post-Marketing Surveillance Department, 3MA Specialty & General Care Medicine Department, 4Biomedical Data Sciences Department, Development & Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan Background: A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD).Patients and methods: Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation.Results: A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment.Conclusion: The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. Keywords: lamotrigine, bipolar, mood episode, post-marketing surveillance study, safety, efficacy
format	article
author	Terao T Ishida A Kimura T Yoshida M Hara T
author_facet	Terao T Ishida A Kimura T Yoshida M Hara T
author_sort	Terao T
title	Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
title_short	Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
title_full	Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
title_fullStr	Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
title_full_unstemmed	Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
title_sort	assessment of safety and efficacy of lamotrigine over the course of 1-year observation in japanese patients with bipolar disorder: post-marketing surveillance study report
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/f18039b371494520ad7a26f6a32755fb
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Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

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