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Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

This post hoc analysis assessed the benefit–risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment‐resistant depression (TRD). The Benefit–Risk Action Team framework was utilized to assess the benefit–risk profile using data f...

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Autores principales: Katz, Eva G., Hough, David, Doherty, Teodora, Lane, Rosanne, Singh, Jaskaran, Levitan, Bennett
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894501/
https://www.ncbi.nlm.nih.gov/pubmed/32860422
http://dx.doi.org/10.1002/cpt.2024
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author Katz, Eva G.
Hough, David
Doherty, Teodora
Lane, Rosanne
Singh, Jaskaran
Levitan, Bennett
author_facet Katz, Eva G.
Hough, David
Doherty, Teodora
Lane, Rosanne
Singh, Jaskaran
Levitan, Bennett
author_sort Katz, Eva G.
collection PubMed
description This post hoc analysis assessed the benefit–risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment‐resistant depression (TRD). The Benefit–Risk Action Team framework was utilized to assess the benefit–risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or responders in induction studies and proportion of stable remitters or stable responders who remained relapse‐free in the maintenance study. Risks were death, suicidal ideation, most common adverse events (AEs), and potential long‐term risks. Per 100 patients on esketamine + AD vs. AD + placebo in induction therapy, 5–21 additional patients would remit and 14–17 additional patients would respond. In maintenance therapy, 19–32 fewer relapses would occur with esketamine. In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo, and dizziness). These findings support a positive benefit–risk balance for esketamine + AD as induction and maintenance treatment in patients with TRD.
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spelling pubmed-78945012021-03-02 Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression Katz, Eva G. Hough, David Doherty, Teodora Lane, Rosanne Singh, Jaskaran Levitan, Bennett Clin Pharmacol Ther Research This post hoc analysis assessed the benefit–risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment‐resistant depression (TRD). The Benefit–Risk Action Team framework was utilized to assess the benefit–risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or responders in induction studies and proportion of stable remitters or stable responders who remained relapse‐free in the maintenance study. Risks were death, suicidal ideation, most common adverse events (AEs), and potential long‐term risks. Per 100 patients on esketamine + AD vs. AD + placebo in induction therapy, 5–21 additional patients would remit and 14–17 additional patients would respond. In maintenance therapy, 19–32 fewer relapses would occur with esketamine. In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo, and dizziness). These findings support a positive benefit–risk balance for esketamine + AD as induction and maintenance treatment in patients with TRD. John Wiley and Sons Inc. 2020-10-13 2021-02 /pmc/articles/PMC7894501/ /pubmed/32860422 http://dx.doi.org/10.1002/cpt.2024 Text en © 2020 Janssen. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research
Katz, Eva G.
Hough, David
Doherty, Teodora
Lane, Rosanne
Singh, Jaskaran
Levitan, Bennett
Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title_full Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title_fullStr Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title_full_unstemmed Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title_short Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression
title_sort benefit–risk assessment of esketamine nasal spray vs. placebo in treatment‐resistant depression
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894501/
https://www.ncbi.nlm.nih.gov/pubmed/32860422
http://dx.doi.org/10.1002/cpt.2024
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