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Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials

BACKGROUND: Preliminary placebo-controlled evidence paved the ground to the US Food and Drug Administration approval extension of lisdexamfetamine for the treatment of moderate-to-severe binge eating disorder (BED) in adults. OBJECTIVES: To provide a preliminary qualitative and quantitative synthesi...

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Autores principales: Fornaro, Michele, Solmi, Marco, Perna, Giampaolo, De Berardis, Domenico, Veronese, Nicola, Orsolini, Laura, Ganança, Licinia, Stubbs, Brendon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966690/
https://www.ncbi.nlm.nih.gov/pubmed/27524900
http://dx.doi.org/10.2147/NDT.S109637
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author Fornaro, Michele
Solmi, Marco
Perna, Giampaolo
De Berardis, Domenico
Veronese, Nicola
Orsolini, Laura
Ganança, Licinia
Stubbs, Brendon
author_facet Fornaro, Michele
Solmi, Marco
Perna, Giampaolo
De Berardis, Domenico
Veronese, Nicola
Orsolini, Laura
Ganança, Licinia
Stubbs, Brendon
author_sort Fornaro, Michele
collection PubMed
description BACKGROUND: Preliminary placebo-controlled evidence paved the ground to the US Food and Drug Administration approval extension of lisdexamfetamine for the treatment of moderate-to-severe binge eating disorder (BED) in adults. OBJECTIVES: To provide a preliminary qualitative and quantitative synthesis of the placebo-controlled, randomized clinical trials (RCTs) considering the efficacy and tolerability of lisdexamfetamine in the acute and/or maintenance treatment of moderate-to-severe BED in adults. METHODS: A preliminary, yet comprehensive, systematic review was performed by accessing a broad range of resources providing publicly available data about lisdexamfetamine at the time of inquiry (March 2016). Study eligibility criteria, participants, and interventions were considered focusing on major clinical and functional outcomes of either efficacy or tolerability of lisdexamfetamine in the treatment of moderate-to-severe BED in adults. RESULTS: Meta-analysis of data pooled from three acute RCTs significantly favored lisdexamfetamine over placebo in the reduction of binge eating days/week, Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating total score, weight, response, and remission rates (all, P≤0.01). In contrast, discontinuation rates due to treatment-emergent adverse events were significantly higher among patients in receipt of lisdexamfetamine (relative risk 2.19, P=0.04) versus placebo. LIMITATIONS: Publication, selection, performance, attrition, reporting, sponsorship, and “diagnostic shift” biases. Lack of inclusion of adverse event effects other than those requiring discontinuation of the trial(s), as well as lack of information about clinically relevant psychiatric or other medical comorbidities, limits the overall generalizability of pooled results. CONCLUSION: Across the included acute phase RCTs, lisdexamfetamine (at 30, 50, or 70 mg/day) led to significant reduction in a number of clinically relevant outcomes compared to placebo. Moreover, safety concerns related to adverse events, high discontinuation rates, and the need for additional long-term maintenance of RCTs solicit careful monitoring of the drug in terms of overall safety and tolerability by further RCTs.
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spelling pubmed-49666902016-08-12 Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials Fornaro, Michele Solmi, Marco Perna, Giampaolo De Berardis, Domenico Veronese, Nicola Orsolini, Laura Ganança, Licinia Stubbs, Brendon Neuropsychiatr Dis Treat Original Research BACKGROUND: Preliminary placebo-controlled evidence paved the ground to the US Food and Drug Administration approval extension of lisdexamfetamine for the treatment of moderate-to-severe binge eating disorder (BED) in adults. OBJECTIVES: To provide a preliminary qualitative and quantitative synthesis of the placebo-controlled, randomized clinical trials (RCTs) considering the efficacy and tolerability of lisdexamfetamine in the acute and/or maintenance treatment of moderate-to-severe BED in adults. METHODS: A preliminary, yet comprehensive, systematic review was performed by accessing a broad range of resources providing publicly available data about lisdexamfetamine at the time of inquiry (March 2016). Study eligibility criteria, participants, and interventions were considered focusing on major clinical and functional outcomes of either efficacy or tolerability of lisdexamfetamine in the treatment of moderate-to-severe BED in adults. RESULTS: Meta-analysis of data pooled from three acute RCTs significantly favored lisdexamfetamine over placebo in the reduction of binge eating days/week, Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating total score, weight, response, and remission rates (all, P≤0.01). In contrast, discontinuation rates due to treatment-emergent adverse events were significantly higher among patients in receipt of lisdexamfetamine (relative risk 2.19, P=0.04) versus placebo. LIMITATIONS: Publication, selection, performance, attrition, reporting, sponsorship, and “diagnostic shift” biases. Lack of inclusion of adverse event effects other than those requiring discontinuation of the trial(s), as well as lack of information about clinically relevant psychiatric or other medical comorbidities, limits the overall generalizability of pooled results. CONCLUSION: Across the included acute phase RCTs, lisdexamfetamine (at 30, 50, or 70 mg/day) led to significant reduction in a number of clinically relevant outcomes compared to placebo. Moreover, safety concerns related to adverse events, high discontinuation rates, and the need for additional long-term maintenance of RCTs solicit careful monitoring of the drug in terms of overall safety and tolerability by further RCTs. Dove Medical Press 2016-07-25 /pmc/articles/PMC4966690/ /pubmed/27524900 http://dx.doi.org/10.2147/NDT.S109637 Text en © 2016 Fornaro et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. 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
Fornaro, Michele
Solmi, Marco
Perna, Giampaolo
De Berardis, Domenico
Veronese, Nicola
Orsolini, Laura
Ganança, Licinia
Stubbs, Brendon
Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title_full Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title_fullStr Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title_full_unstemmed Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title_short Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
title_sort lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966690/
https://www.ncbi.nlm.nih.gov/pubmed/27524900
http://dx.doi.org/10.2147/NDT.S109637
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