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Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials

INTRODUCTION/OBJECTIVE: Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD). METHODS: Data were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD durati...

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Autores principales: Montgomery, Stuart A., Gommoll, Carl P., Chen, Changzheng, Greenberg, William M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411644/
https://www.ncbi.nlm.nih.gov/pubmed/24902007
http://dx.doi.org/10.1017/S1092852914000273
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author Montgomery, Stuart A.
Gommoll, Carl P.
Chen, Changzheng
Greenberg, William M.
author_facet Montgomery, Stuart A.
Gommoll, Carl P.
Chen, Changzheng
Greenberg, William M.
author_sort Montgomery, Stuart A.
collection PubMed
description INTRODUCTION/OBJECTIVE: Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD). METHODS: Data were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery–Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10). RESULTS: In the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (−15.8 versus −12.9; LS mean difference, −2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001). DISCUSSION: Clinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission. CONCLUSION: Levomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18–78, with varying histories and symptom severity.
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spelling pubmed-44116442015-05-01 Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials Montgomery, Stuart A. Gommoll, Carl P. Chen, Changzheng Greenberg, William M. CNS Spectr Original Research INTRODUCTION/OBJECTIVE: Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD). METHODS: Data were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery–Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10). RESULTS: In the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (−15.8 versus −12.9; LS mean difference, −2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001). DISCUSSION: Clinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission. CONCLUSION: Levomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18–78, with varying histories and symptom severity. Cambridge University Press 2014-06-05 2015-04 /pmc/articles/PMC4411644/ /pubmed/24902007 http://dx.doi.org/10.1017/S1092852914000273 Text en © Cambridge University Press 2014 The online version of this article is published within an Open Access environment subject to the conditions of the Creative Commons Attribution licence http://creativecommons.org/licenses/by/3.0/
spellingShingle Original Research
Montgomery, Stuart A.
Gommoll, Carl P.
Chen, Changzheng
Greenberg, William M.
Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title_full Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title_fullStr Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title_full_unstemmed Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title_short Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
title_sort efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411644/
https://www.ncbi.nlm.nih.gov/pubmed/24902007
http://dx.doi.org/10.1017/S1092852914000273
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