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Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements

BACKGROUND: When use of a single antiseizure medication (ASM) fails to induce seizure remission, add-on therapy is justified. Perampanel (PER) is approved in Europe as adjunctive therapy for focal, focal to bilateral tonic-clonic seizures and generalized tonic-clonic seizures. Aim of the study was t...

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Autores principales: Bonanni, Paolo, Gambardella, Antonio, Tinuper, Paolo, Acone, Benedetto, Perucca, Emilio, Coppola, Giangennaro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549193/
https://www.ncbi.nlm.nih.gov/pubmed/34702211
http://dx.doi.org/10.1186/s12883-021-02450-y
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author Bonanni, Paolo
Gambardella, Antonio
Tinuper, Paolo
Acone, Benedetto
Perucca, Emilio
Coppola, Giangennaro
author_facet Bonanni, Paolo
Gambardella, Antonio
Tinuper, Paolo
Acone, Benedetto
Perucca, Emilio
Coppola, Giangennaro
author_sort Bonanni, Paolo
collection PubMed
description BACKGROUND: When use of a single antiseizure medication (ASM) fails to induce seizure remission, add-on therapy is justified. Perampanel (PER) is approved in Europe as adjunctive therapy for focal, focal to bilateral tonic-clonic seizures and generalized tonic-clonic seizures. Aim of the study was to establish whether PER is suitable for first add-on use. METHODS: A Delphi methodology was adopted to assess consensus on a list of 39 statements produced by an Expert Board of 5 epileptologists. Using an iterative process, statements were finalized by a Delphi Panel of 84 Italian pediatric and adult neurologists. Each statement was rated anonymously to determine level of agreement on a 9-point Likert scale. Consensus was established as agreement by at least 80% of the panelists. The relevance of each statement was also assessed on a 3-point scale. RESULTS: Consensus was achieved for 37 statements. Characteristics of PER considered to justify its use as first add-on include evidence of a positive impact on quality of life based on long term retention data, efficacy, tolerability, and ease of use; no worsening of cognitive functions and sleep quality; a low potential for drug interactions; a unique mechanism of action. Potential unfavorable factors are the need for a relatively slow dose titration; the potential occurrence of behavioral adverse effects; lack of information on safety when used in pregnancy; limited access to plasma PER levels. CONCLUSION: Perampanel has many features which justify its use as a first add-on. Choice of an ASM as first add-on should be tailored to individual characteristics. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02450-y.
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spelling pubmed-85491932021-10-27 Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements Bonanni, Paolo Gambardella, Antonio Tinuper, Paolo Acone, Benedetto Perucca, Emilio Coppola, Giangennaro BMC Neurol Research Article BACKGROUND: When use of a single antiseizure medication (ASM) fails to induce seizure remission, add-on therapy is justified. Perampanel (PER) is approved in Europe as adjunctive therapy for focal, focal to bilateral tonic-clonic seizures and generalized tonic-clonic seizures. Aim of the study was to establish whether PER is suitable for first add-on use. METHODS: A Delphi methodology was adopted to assess consensus on a list of 39 statements produced by an Expert Board of 5 epileptologists. Using an iterative process, statements were finalized by a Delphi Panel of 84 Italian pediatric and adult neurologists. Each statement was rated anonymously to determine level of agreement on a 9-point Likert scale. Consensus was established as agreement by at least 80% of the panelists. The relevance of each statement was also assessed on a 3-point scale. RESULTS: Consensus was achieved for 37 statements. Characteristics of PER considered to justify its use as first add-on include evidence of a positive impact on quality of life based on long term retention data, efficacy, tolerability, and ease of use; no worsening of cognitive functions and sleep quality; a low potential for drug interactions; a unique mechanism of action. Potential unfavorable factors are the need for a relatively slow dose titration; the potential occurrence of behavioral adverse effects; lack of information on safety when used in pregnancy; limited access to plasma PER levels. CONCLUSION: Perampanel has many features which justify its use as a first add-on. Choice of an ASM as first add-on should be tailored to individual characteristics. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02450-y. BioMed Central 2021-10-26 /pmc/articles/PMC8549193/ /pubmed/34702211 http://dx.doi.org/10.1186/s12883-021-02450-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Bonanni, Paolo
Gambardella, Antonio
Tinuper, Paolo
Acone, Benedetto
Perucca, Emilio
Coppola, Giangennaro
Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title_full Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title_fullStr Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title_full_unstemmed Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title_short Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements
title_sort perampanel as first add-on antiseizure medication: italian consensus clinical practice statements
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549193/
https://www.ncbi.nlm.nih.gov/pubmed/34702211
http://dx.doi.org/10.1186/s12883-021-02450-y
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