Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder

Eiji Harada,1 Osamu Shirakawa,2 Yoichi Satoi,3 Lauren B Marangell,4 Rodrigo Escobar5 1Eli Lilly Japan K.K., Medicines Development Unit Japan, Medical Science, Kobe, 2Department of Neuropsychiatry, Kinki University Faculty of Medicine, Osakasayama, 3Eli Lilly Japan K.K., Medicines Development Unit J...

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Autores principales:	Harada E, Shirakawa O, Satoi Y, Marangell LB, Escobar R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	antidepressant dose duloxetine major depressive disorder titration Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/605ed851076645a6ab46bdc7d4e1a89b
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spelling	oai:doaj.org-article:605ed851076645a6ab46bdc7d4e1a89b2021-12-02T06:20:57ZTreatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder1178-2021https://doaj.org/article/605ed851076645a6ab46bdc7d4e1a89b2016-01-01T00:00:00Zhttps://www.dovepress.com/treatment-discontinuation-and-tolerability-as-a-function-of-dose-and-t-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Eiji Harada,1 Osamu Shirakawa,2 Yoichi Satoi,3 Lauren B Marangell,4 Rodrigo Escobar5 1Eli Lilly Japan K.K., Medicines Development Unit Japan, Medical Science, Kobe, 2Department of Neuropsychiatry, Kinki University Faculty of Medicine, Osakasayama, 3Eli Lilly Japan K.K., Medicines Development Unit Japan, Statistical Science, Kobe, Japan; 4The University of Texas Health Science Center School of Medicine, Houston, TX, 5Eli Lilly and Company, Neuroscience, Indianapolis, IN, USA Purpose: We sought to better understand how dose and titration with duloxetine treatment may impact tolerability and treatment discontinuation in patients with major depressive disorder.Patients and methods: We investigated Phase III duloxetine trials. Group 1 was a single placebo-controlled study with a 20 mg initial dose and a slow titration to 40 and 60 mg. Group 2 was a single study with a 40 mg initial dose and final “active” doses of 40 and 60 mg (5 mg control group), with 1-week titration. Group 3 consisted of eight placebo-controlled studies with starting doses of 40, 60, and 80 mg/day with minimal titration (final dose 40–120 mg/day). Tolerability was measured by rate of discontinuation due to adverse events (DCAE).Results: The DCAE in Group 1 were 3.6% in the 60 mg group, 3.3% in the 40 mg group, and 3.2% in the placebo group. In Group 2, the DCAE were 15.0% in the 60 mg group, 8.1% in the 40 mg group, and 4.9% in the 5 mg group. In Group 3, the DCAE were 9.7% and 4.2% in the duloxetine and placebo groups, respectively.Conclusion: This study suggests that starting dose and titration may have impacted tolerability and treatment discontinuation. A lower starting dose of duloxetine and slower titration may contribute to improving treatment tolerability for patients with major depressive disorder. Keywords: antidepressant, dose, duloxetine, major depressive disorder, titrationHarada EShirakawa OSatoi YMarangell LBEscobar RDove Medical Pressarticleantidepressantdoseduloxetinemajor depressive disordertitrationNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2016, Iss Issue 1, Pp 89-97 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	antidepressant dose duloxetine major depressive disorder titration Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	antidepressant dose duloxetine major depressive disorder titration Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Harada E Shirakawa O Satoi Y Marangell LB Escobar R Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
description	Eiji Harada,1 Osamu Shirakawa,2 Yoichi Satoi,3 Lauren B Marangell,4 Rodrigo Escobar5 1Eli Lilly Japan K.K., Medicines Development Unit Japan, Medical Science, Kobe, 2Department of Neuropsychiatry, Kinki University Faculty of Medicine, Osakasayama, 3Eli Lilly Japan K.K., Medicines Development Unit Japan, Statistical Science, Kobe, Japan; 4The University of Texas Health Science Center School of Medicine, Houston, TX, 5Eli Lilly and Company, Neuroscience, Indianapolis, IN, USA Purpose: We sought to better understand how dose and titration with duloxetine treatment may impact tolerability and treatment discontinuation in patients with major depressive disorder.Patients and methods: We investigated Phase III duloxetine trials. Group 1 was a single placebo-controlled study with a 20 mg initial dose and a slow titration to 40 and 60 mg. Group 2 was a single study with a 40 mg initial dose and final “active” doses of 40 and 60 mg (5 mg control group), with 1-week titration. Group 3 consisted of eight placebo-controlled studies with starting doses of 40, 60, and 80 mg/day with minimal titration (final dose 40–120 mg/day). Tolerability was measured by rate of discontinuation due to adverse events (DCAE).Results: The DCAE in Group 1 were 3.6% in the 60 mg group, 3.3% in the 40 mg group, and 3.2% in the placebo group. In Group 2, the DCAE were 15.0% in the 60 mg group, 8.1% in the 40 mg group, and 4.9% in the 5 mg group. In Group 3, the DCAE were 9.7% and 4.2% in the duloxetine and placebo groups, respectively.Conclusion: This study suggests that starting dose and titration may have impacted tolerability and treatment discontinuation. A lower starting dose of duloxetine and slower titration may contribute to improving treatment tolerability for patients with major depressive disorder. Keywords: antidepressant, dose, duloxetine, major depressive disorder, titration
format	article
author	Harada E Shirakawa O Satoi Y Marangell LB Escobar R
author_facet	Harada E Shirakawa O Satoi Y Marangell LB Escobar R
author_sort	Harada E
title	Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title_short	Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title_full	Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title_fullStr	Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title_full_unstemmed	Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title_sort	treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/605ed851076645a6ab46bdc7d4e1a89b
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Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder

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