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The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

BACKGROUND: The objectives of this meta‐analysis of data from randomized, placebo‐controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD)...

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Autores principales: Florea, Ioana, Loft, Henrik, Danchenko, Natalya, Rive, Benoît, Brignone, Melanie, Merikle, Elizabeth, Jacobsen, Paula L., Sheehan, David V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346512/
https://www.ncbi.nlm.nih.gov/pubmed/28293465
http://dx.doi.org/10.1002/brb3.622
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author Florea, Ioana
Loft, Henrik
Danchenko, Natalya
Rive, Benoît
Brignone, Melanie
Merikle, Elizabeth
Jacobsen, Paula L.
Sheehan, David V.
author_facet Florea, Ioana
Loft, Henrik
Danchenko, Natalya
Rive, Benoît
Brignone, Melanie
Merikle, Elizabeth
Jacobsen, Paula L.
Sheehan, David V.
author_sort Florea, Ioana
collection PubMed
description BACKGROUND: The objectives of this meta‐analysis of data from randomized, placebo‐controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD). METHODS: Data from nine short‐term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random‐effects meta‐analysis, which used aggregated study‐level data for all therapeutic vortioxetine doses and a mixed‐effect model for repeated measures using the full analysis set. RESULTS: A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5–20 mg/day). At study end, the meta‐analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n = 564, change from baseline versus placebo [Δ] −0.24, p = NS; 10 mg, n = 445, Δ −1.68, p ≤ .001; 15 mg, n = 204, Δ −0.91, p = NS; 20 mg, n = 340, Δ −1.94, p ≤ .01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n = 170/573; odds ratio [OR] relative to placebo 1.7, p < .001) and 20 mg (n = 144/447; OR 1.6, p < .05), but not 5 mg (n = 207/757; OR 1.1, p = NS) or 15 mg (n = 92/295; OR 1.3, p = NS). CONCLUSION: Vortioxetine 5–20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.
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spelling pubmed-53465122017-03-14 The effect of vortioxetine on overall patient functioning in patients with major depressive disorder Florea, Ioana Loft, Henrik Danchenko, Natalya Rive, Benoît Brignone, Melanie Merikle, Elizabeth Jacobsen, Paula L. Sheehan, David V. Brain Behav Original Research BACKGROUND: The objectives of this meta‐analysis of data from randomized, placebo‐controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD). METHODS: Data from nine short‐term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random‐effects meta‐analysis, which used aggregated study‐level data for all therapeutic vortioxetine doses and a mixed‐effect model for repeated measures using the full analysis set. RESULTS: A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5–20 mg/day). At study end, the meta‐analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n = 564, change from baseline versus placebo [Δ] −0.24, p = NS; 10 mg, n = 445, Δ −1.68, p ≤ .001; 15 mg, n = 204, Δ −0.91, p = NS; 20 mg, n = 340, Δ −1.94, p ≤ .01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n = 170/573; odds ratio [OR] relative to placebo 1.7, p < .001) and 20 mg (n = 144/447; OR 1.6, p < .05), but not 5 mg (n = 207/757; OR 1.1, p = NS) or 15 mg (n = 92/295; OR 1.3, p = NS). CONCLUSION: Vortioxetine 5–20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission. John Wiley and Sons Inc. 2017-02-02 /pmc/articles/PMC5346512/ /pubmed/28293465 http://dx.doi.org/10.1002/brb3.622 Text en © 2017 The Authors. Brain and Behavior published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Research
Florea, Ioana
Loft, Henrik
Danchenko, Natalya
Rive, Benoît
Brignone, Melanie
Merikle, Elizabeth
Jacobsen, Paula L.
Sheehan, David V.
The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title_full The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title_fullStr The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title_full_unstemmed The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title_short The effect of vortioxetine on overall patient functioning in patients with major depressive disorder
title_sort effect of vortioxetine on overall patient functioning in patients with major depressive disorder
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346512/
https://www.ncbi.nlm.nih.gov/pubmed/28293465
http://dx.doi.org/10.1002/brb3.622
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