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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)...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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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. |
format | Online Article Text |
id | pubmed-5346512 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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