Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study

Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study

Author Hufnagel, Andreas Google Scholar
Ben-Menachem, Elinor Google Scholar
Gabbai, Alberto Alain Autor UNIFESP Google Scholar
Falcao, Amilcar Google Scholar
Almeida, Luis Google Scholar
Soares-da-Silva, Patricio Google Scholar
BIA-2093-302 Investigators Study Google Scholar
Institution Univ Essen Gesamthsch
Sahlgrens Univ Hosp
Universidade Federal de São Paulo (UNIFESP)
Univ Coimbra
4Hlth Consulting
Univ Aveiro
BIAL Portela & Ca SA
Univ Porto
Abstract Objective: To evaluate the long-term safety, tolerability and efficacy of once-daily eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.Methods: One-year open-label extension (OLE) study with ESL in patients who completed a randomised, double-blind placebo-controlled trial (study BIA-2093-302; Epilepsy Res. 89 (2010) 278-285). Starting dose was 800 mg once-daily, for 4 weeks; thereafter, dose could be individualised within the 400-1200 mg range. Doses of concomitant antiepileptic drugs were to be kept stable.Results: Overall, 325 patients were enrolled (intent-to-treat population); 223 (68.6%) patients completed 1-year of treatment. ESL median dose was 800 mg once-daily. Compared to the baseline period of the double-blind study completed prior to this OLE study, median seizure frequency decreased by 32% in weeks 1-4, and between 37% and 39% thereafter. the responder rate (seizure reduction >= 50%) was 37% during weeks 1-4 and thereafter ranged between 38% and 42% per 12-week interval. Proportion of seizure-free patients per 12-week interval ranged between 5% and 11%. Improvements from baseline in several Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and Montgomery Asberg Depression Rating Scale (MADRS) scores were observed. Adverse events (AEs) were reported by 83% of patients. AEs occurring in >= 10% of patients were dizziness, headache and somnolence. AEs were usually of mild to moderate intensity.Conclusion: in this study, ESL demonstrated a sustained therapeutic effect and was well tolerated during 1-year add-on treatment of adults with partial-onset seizures. Additionally, significant improvements in quality of life domains and depressive symptoms were observed under long-term treatment with once-daily ESL. (c) 2012 Elsevier B.V. All rights reserved.
Keywords Eslicarbazepine acetate
Antiepileptics
Long-term treatment
Depressive symptoms
Quality of life
Language English
Sponsor BIAL - Portela Co, S.A
Date 2013-02-01
Published in Epilepsy Research. Amsterdam: Elsevier B.V., v. 103, n. 2-3, p. 262-269, 2013.
ISSN 0920-1211 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 262-269
Origin http://dx.doi.org/10.1016/j.eplepsyres.2012.07.014
Access rights Closed access
Type Article
Web of Science ID WOS:000315372600016
URI http://repositorio.unifesp.br/handle/11600/35933

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