Please use this identifier to cite or link to this item: https://repositorio.unifesp.br/11600/35933
Title: 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
Authors: Hufnagel, Andreas
Ben-Menachem, Elinor
Gabbai, Alberto Alain [UNIFESP]
Falcao, Amilcar
Almeida, Luis
Soares-da-Silva, Patricio
BIA-2093-302 Investigators Study
Keywords: Eslicarbazepine acetate
Antiepileptics
Long-term treatment
Depressive symptoms
Quality of life
Issue Date: 2013-02-01
Publisher: Elsevier B.V.
Citation: Epilepsy Research. Amsterdam: Elsevier B.V., v. 103, n. 2-3, p. 262-269, 2013.
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.
URI: http://repositorio.unifesp.br/handle/11600/35933
metadata.dc.language.iso: eng
Other Identifiers: http://dx.doi.org/10.1016/j.eplepsyres.2012.07.014
metadata.dc.rights: Acesso restrito
metadata.dc.type: Artigo
metadata.dc.format.extent: 262-269
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