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

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dc.contributor.authorHufnagel, Andreas
dc.contributor.authorBen-Menachem, Elinor
dc.contributor.authorGabbai, Alberto Alain [UNIFESP]
dc.contributor.authorFalcao, Amilcar
dc.contributor.authorAlmeida, Luis
dc.contributor.authorSoares-da-Silva, Patricio
dc.contributor.authorBIA-2093-302 Investigators Study
dc.contributor.institutionUniv Essen Gesamthsch
dc.contributor.institutionSahlgrens Univ Hosp
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Coimbra
dc.contributor.institution4Hlth Consulting
dc.contributor.institutionUniv Aveiro
dc.contributor.institutionBIAL Portela & Ca SA
dc.contributor.institutionUniv Porto
dc.date.accessioned2016-01-24T14:31:13Z
dc.date.available2016-01-24T14:31:13Z
dc.date.issued2013-02-01
dc.description.abstractObjective: 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.en
dc.description.affiliationUniv Essen Gesamthsch, Dept Neurol, Essen, Germany
dc.description.affiliationSahlgrens Univ Hosp, Sahlgren Acad, Dept Clin Neurosci & Physiol, Gothenburg, Sweden
dc.description.affiliationUniversidade Federal de São Paulo, Escola Paulista Med, Ctr Estudos Neurol, São Paulo, Brazil
dc.description.affiliationUniv Coimbra, Fac Pharm, Coimbra, Portugal
dc.description.affiliation4Hlth Consulting, Cantanhede, Portugal
dc.description.affiliationUniv Aveiro, Dept Hlth Sci, P-3800 Aveiro, Portugal
dc.description.affiliationBIAL Portela & Ca SA, Dept Res & Dev, P-4745457 S Mamede Do Coronado, Portugal
dc.description.affiliationUniv Porto, Fac Med, Dept Pharmacol & Therapeut, P-4100 Oporto, Portugal
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Escola Paulista Med, Ctr Estudos Neurol, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipBIAL - Portela Co, S.A
dc.format.extent262-269
dc.identifierhttp://dx.doi.org/10.1016/j.eplepsyres.2012.07.014
dc.identifier.citationEpilepsy Research. Amsterdam: Elsevier B.V., v. 103, n. 2-3, p. 262-269, 2013.
dc.identifier.doi10.1016/j.eplepsyres.2012.07.014
dc.identifier.issn0920-1211
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/35933
dc.identifier.wosWOS:000315372600016
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofEpilepsy Research
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.subjectEslicarbazepine acetateen
dc.subjectAntiepilepticsen
dc.subjectLong-term treatmenten
dc.subjectDepressive symptomsen
dc.subjectQuality of lifeen
dc.titleLong-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 studyen
dc.typeinfo:eu-repo/semantics/article
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