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PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice
The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Berlin Heidelberg
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8940799/ https://www.ncbi.nlm.nih.gov/pubmed/34427754 http://dx.doi.org/10.1007/s00415-021-10751-y |
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author | Villanueva, Vicente D’Souza, Wendyl Goji, Hiroko Kim, Dong Wook Liguori, Claudio McMurray, Rob Najm, Imad Santamarina, Estevo Steinhoff, Bernhard J. Vlasov, Pavel Wu, Tony Trinka, Eugen |
author_facet | Villanueva, Vicente D’Souza, Wendyl Goji, Hiroko Kim, Dong Wook Liguori, Claudio McMurray, Rob Najm, Imad Santamarina, Estevo Steinhoff, Bernhard J. Vlasov, Pavel Wu, Tony Trinka, Eugen |
author_sort | Villanueva, Vicente |
collection | PubMed |
description | The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (≥ 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (≥ 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-021-10751-y. |
format | Online Article Text |
id | pubmed-8940799 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-89407992022-04-07 PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice Villanueva, Vicente D’Souza, Wendyl Goji, Hiroko Kim, Dong Wook Liguori, Claudio McMurray, Rob Najm, Imad Santamarina, Estevo Steinhoff, Bernhard J. Vlasov, Pavel Wu, Tony Trinka, Eugen J Neurol Original Communication The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (≥ 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (≥ 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-021-10751-y. Springer Berlin Heidelberg 2021-08-24 2022 /pmc/articles/PMC8940799/ /pubmed/34427754 http://dx.doi.org/10.1007/s00415-021-10751-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/) . |
spellingShingle | Original Communication Villanueva, Vicente D’Souza, Wendyl Goji, Hiroko Kim, Dong Wook Liguori, Claudio McMurray, Rob Najm, Imad Santamarina, Estevo Steinhoff, Bernhard J. Vlasov, Pavel Wu, Tony Trinka, Eugen PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title | PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title_full | PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title_fullStr | PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title_full_unstemmed | PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title_short | PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
title_sort | permit study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice |
topic | Original Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8940799/ https://www.ncbi.nlm.nih.gov/pubmed/34427754 http://dx.doi.org/10.1007/s00415-021-10751-y |
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