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

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...

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Autores principales: Harada, Eiji, Shirakawa, Osamu, Satoi, Yoichi, Marangell, Lauren B, Escobar, Rodrigo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4714731/
https://www.ncbi.nlm.nih.gov/pubmed/26811681
http://dx.doi.org/10.2147/NDT.S86598
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author Harada, Eiji
Shirakawa, Osamu
Satoi, Yoichi
Marangell, Lauren B
Escobar, Rodrigo
author_facet Harada, Eiji
Shirakawa, Osamu
Satoi, Yoichi
Marangell, Lauren B
Escobar, Rodrigo
author_sort Harada, Eiji
collection PubMed
description 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.
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spelling pubmed-47147312016-01-25 Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder Harada, Eiji Shirakawa, Osamu Satoi, Yoichi Marangell, Lauren B Escobar, Rodrigo Neuropsychiatr Dis Treat Original Research 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. Dove Medical Press 2016-01-11 /pmc/articles/PMC4714731/ /pubmed/26811681 http://dx.doi.org/10.2147/NDT.S86598 Text en © 2016 Harada et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Harada, Eiji
Shirakawa, Osamu
Satoi, Yoichi
Marangell, Lauren B
Escobar, Rodrigo
Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder
title 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_short 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
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4714731/
https://www.ncbi.nlm.nih.gov/pubmed/26811681
http://dx.doi.org/10.2147/NDT.S86598
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