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Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures

Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures
Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures

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.

Antiseizure drug, Eslicarbazepine acetate, Open-label extension, Pediatric, Safety, Tolerability
1525-5050
Sankar, Raman
5cb62d54-1f1c-45d8-92f3-bef0e596b451
Kirkham, Fenella J.
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Holmes, Gregory L.
56f4b415-3c28-497b-84c3-4fb69031e716
Pina-Garza, J. Eric
c839cf84-4c71-45ed-8a82-680e2346c83b
Wheless, James
0210a973-d02a-4e14-bbce-5daa6950a336
Gama, Helena
b9e92b6b-1038-4091-9100-f87c03e25db6
Moreira, Joana
55a8ba5d-0294-4443-a5a0-97a96707e6fa
Cantu, David
56fa410d-44fa-453a-a420-93e18da4e22a
Tosiello, Robert
324f0cd2-2eed-4212-bfee-8eaf14d9a7c9
Blum, David
f201306e-d9af-4d7d-bc05-cb463be5f941
Grinnell, Todd
6f61331d-8fbc-4c7d-bfa1-b9bdf6aa37bf
Sankar, Raman
5cb62d54-1f1c-45d8-92f3-bef0e596b451
Kirkham, Fenella J.
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Holmes, Gregory L.
56f4b415-3c28-497b-84c3-4fb69031e716
Pina-Garza, J. Eric
c839cf84-4c71-45ed-8a82-680e2346c83b
Wheless, James
0210a973-d02a-4e14-bbce-5daa6950a336
Gama, Helena
b9e92b6b-1038-4091-9100-f87c03e25db6
Moreira, Joana
55a8ba5d-0294-4443-a5a0-97a96707e6fa
Cantu, David
56fa410d-44fa-453a-a420-93e18da4e22a
Tosiello, Robert
324f0cd2-2eed-4212-bfee-8eaf14d9a7c9
Blum, David
f201306e-d9af-4d7d-bc05-cb463be5f941
Grinnell, Todd
6f61331d-8fbc-4c7d-bfa1-b9bdf6aa37bf

Sankar, Raman, Kirkham, Fenella J., Holmes, Gregory L., Pina-Garza, J. Eric, Wheless, James, Gama, Helena, Moreira, Joana, Cantu, David, Tosiello, Robert, Blum, David and Grinnell, Todd (2020) Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures. Epilepsy and Behavior, 112, [107458]. (doi:10.1016/j.yebeh.2020.107458).

Record type: Article

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.

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More information

Accepted/In Press date: 31 August 2020
e-pub ahead of print date: 24 September 2020
Published date: November 2020
Additional Information: Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Keywords: Antiseizure drug, Eslicarbazepine acetate, Open-label extension, Pediatric, Safety, Tolerability

Identifiers

Local EPrints ID: 446143
URI: http://eprints.soton.ac.uk/id/eprint/446143
ISSN: 1525-5050
PURE UUID: ad67b853-fd26-4bfc-82fd-50fd487ae72e
ORCID for Fenella J. Kirkham: ORCID iD orcid.org/0000-0002-2443-7958

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Date deposited: 21 Jan 2021 17:35
Last modified: 19 Oct 2022 01:37

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Contributors

Author: Raman Sankar
Author: Gregory L. Holmes
Author: J. Eric Pina-Garza
Author: James Wheless
Author: Helena Gama
Author: Joana Moreira
Author: David Cantu
Author: Robert Tosiello
Author: David Blum
Author: Todd Grinnell

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