eprintid: 10112849
rev_number: 28
eprint_status: archive
userid: 608
dir: disk0/10/11/28/49
datestamp: 2020-10-22 09:27:09
lastmod: 2022-01-13 23:32:08
status_changed: 2020-10-22 09:27:09
type: article
metadata_visibility: show
creators_name: Sankar, R
creators_name: Kirkham, FJ
creators_name: Holmes, GL
creators_name: Pina-Garza, JE
creators_name: Wheless, J
creators_name: Gama, H
creators_name: Moreira, J
creators_name: Cantu, D
creators_name: Tosiello, R
creators_name: Blum, D
creators_name: Grinnell, T
title: Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures
ispublished: pub
divisions: UCL
divisions: B02
divisions: D13
divisions: G26
keywords: Pediatric, Eslicarbazepine acetate, Safety, Tolerability, Open-label extension, Antiseizure drug
note: This article is published under a Creative Commons license (https://creativecommons.org/licenses/by-nc-nd/4.0/)
abstract: Objective: The objective of this study was to evaluate long-term safety and tolerability outcomes in two open-label extension (OLE) studies of adjunctive eslicarbazepine acetate (ESL) in children with focal seizures. / Methods: Safety data from patients aged 4–17 years in OLEs of Studies 2093-208 and -305 were pooled and analyzed. Studies 208 and 305 were randomized, double-blind, placebo-controlled studies of adjunctive treatment with ESL in children with focal seizures refractory to treatment with 1–2 antiseizure drugs; patients could continue into uncontrolled OLEs (up to 5 years total duration). The OLEs evaluated the safety and tolerability of ESL (10–30 mg/kg/day; maximum 1200 mg/day). / Results: The 1-year OLE and post-1-year OLE safety populations comprised 337 and 177 ESL-treated patients, respectively. The overall incidence of treatment-emergent adverse events (TEAEs) with ESL was 64.1% during the 1-year OLE and 52.5% during the post-1-year OLE. Nasopharyngitis, partial seizures, vomiting, pyrexia, headache, somnolence, and respiratory tract infection were the most frequently reported TEAEs during the 1-year OLE. The overall incidence of serious adverse events (AEs) was 8.9% during the 1-year OLE and 10.2% during the post-1-year OLE. Partial seizures (1.2%) and pneumonia (1.2%) were the most frequently reported serious AEs during the 1-year OLE. The overall incidence of TEAEs leading to discontinuation was 4.2% during the 1-year OLE and 0.6% during the post-1-year OLE. Partial seizures (1.5%) was the most frequently reported TEAE leading to discontinuation during the 1-year OLE. / Conclusions: Overall, long-term treatment with ESL was generally well tolerated in pediatric patients aged 4–17 years with focal seizures. TEAEs were comparable to those observed in adults with no new events of concern.
date: 2020-11
date_type: published
official_url: http://dx.doi.org/10.1016/j.yebeh.2020.107458
oa_status: green
full_text_type: pub
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1821228
doi: 10.1016/j.yebeh.2020.107458
lyricists_name: Kirkham, Fenella
lyricists_id: FKIRK91
actors_name: Dewerpe, Marie
actors_id: MDDEW97
actors_role: owner
full_text_status: public
publication: Epilepsy and Behavior
volume: 112
article_number: 107458
citation:        Sankar, R;    Kirkham, FJ;    Holmes, GL;    Pina-Garza, JE;    Wheless, J;    Gama, H;    Moreira, J;                 ... Grinnell, T; + view all <#>        Sankar, R;  Kirkham, FJ;  Holmes, GL;  Pina-Garza, JE;  Wheless, J;  Gama, H;  Moreira, J;  Cantu, D;  Tosiello, R;  Blum, D;  Grinnell, T;   - view fewer <#>    (2020)    Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures.                   Epilepsy and Behavior , 112     , Article 107458.  10.1016/j.yebeh.2020.107458 <https://doi.org/10.1016/j.yebeh.2020.107458>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10112849/1/Kirkham_1-s2.0-S1525505020306387-main.pdf