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Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy
OBJECTIVE: To assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add‐on treatment over 6 months in a real‐world adult population with partial‐onset seizures. METHODS: This non‐interventional, multicenter, prospective study was p...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5067651/ https://www.ncbi.nlm.nih.gov/pubmed/26915469 http://dx.doi.org/10.1111/ane.12574 |
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author | Holtkamp, M. McMurray, R. Bagul, M. Sousa, R. Kockelmann, E. |
author_facet | Holtkamp, M. McMurray, R. Bagul, M. Sousa, R. Kockelmann, E. |
author_sort | Holtkamp, M. |
collection | PubMed |
description | OBJECTIVE: To assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add‐on treatment over 6 months in a real‐world adult population with partial‐onset seizures. METHODS: This non‐interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add‐on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected. RESULTS: After 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE‐10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue. CONCLUSIONS: This study shows that ESL was well tolerated and efficacious as add‐on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed. |
format | Online Article Text |
id | pubmed-5067651 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50676512016-11-01 Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy Holtkamp, M. McMurray, R. Bagul, M. Sousa, R. Kockelmann, E. Acta Neurol Scand Original Articles OBJECTIVE: To assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add‐on treatment over 6 months in a real‐world adult population with partial‐onset seizures. METHODS: This non‐interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add‐on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected. RESULTS: After 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE‐10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue. CONCLUSIONS: This study shows that ESL was well tolerated and efficacious as add‐on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed. John Wiley and Sons Inc. 2016-02-24 2016-07 /pmc/articles/PMC5067651/ /pubmed/26915469 http://dx.doi.org/10.1111/ane.12574 Text en © 2016 Esai Europe Ltd. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Holtkamp, M. McMurray, R. Bagul, M. Sousa, R. Kockelmann, E. Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title | Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title_full | Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title_fullStr | Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title_full_unstemmed | Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title_short | Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
title_sort | real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5067651/ https://www.ncbi.nlm.nih.gov/pubmed/26915469 http://dx.doi.org/10.1111/ane.12574 |
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