Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Integrated analysis of pooled data from double-blind phase III clinical studies

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dc.contributor.author Gil-Nagel, Antonio
dc.contributor.author Elger, Christian
dc.contributor.author Ben-Menachem, Elinor
dc.contributor.author Halasz, Peter
dc.contributor.author Lopes-Lima, Jose
dc.contributor.author Gabbai, Alberto A. [UNIFESP]
dc.contributor.author Nunes, Teresa
dc.contributor.author Falcao, Amilcar
dc.contributor.author Almeida, Luis
dc.contributor.author Soares-da-Silva, Patricio
dc.date.accessioned 2016-01-24T14:30:51Z
dc.date.available 2016-01-24T14:30:51Z
dc.date.issued 2013-01-01
dc.identifier http://dx.doi.org/10.1111/j.1528-1167.2012.03605.x
dc.identifier.citation Epilepsia. Hoboken: Wiley-Blackwell, v. 54, n. 1, p. 98-107, 2013.
dc.identifier.issn 0013-9580
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/35667
dc.description.abstract Purpose: To evaluate the efficacy and safety profile of eslicarbazepine acetate (ESL) added to stable antiepileptic therapy in adults with partial-onset seizures. Methods: Data from 1,049 patients enrolled from 125 centers, in 23 countries, in three phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed. Following a 2-week titration period, ESL was administered at 400 mg, 800 mg, and 1,200 mg once-daily doses for 12 weeks. Key Findings: Seizure frequency was significantly reduced with ESL 800 mg (p < 0.0001) and 1,200 mg (p < 0.0001) compared to placebo. Median relative reduction in seizure frequency was, respectively, 35% and 39% (placebo 15%) and responder rate was 36% and 44% (placebo 22%). ESL was more efficacious than placebo regardless of gender, geographic region, epilepsy duration, age at time of diagnosis, seizure type, and number and type of concomitant antiepileptic drugs (AEDs). Incidence of adverse events (AEs) and AEs leading to discontinuation were dose dependent. AEs occurred mainly during the first weeks of treatment, with no difference between groups after 6 weeks. Most common AEs (>10% patients) were dizziness, somnolence, and headache. the incidence of AEs in ESL groups compared to placebo was generally consistent among different subpopulations. Significance: Once-daily ESL 800 mg and 1,200 mg showed consistent results across all efficacy and safety end points. Results were independent of study population characteristics and type and number of concomitant AEDs. en
dc.description.sponsorship BIAL - Portela Co, SA
dc.description.sponsorship BIAL
dc.format.extent 98-107
dc.language.iso eng
dc.publisher Wiley-Blackwell
dc.relation.ispartof Epilepsia
dc.rights Acesso aberto
dc.subject Adjunctive therapy en
dc.subject Adults en
dc.subject Antiepileptic drugs en
dc.subject Eslicarbazepine acetate en
dc.subject Partial-onset seizures en
dc.subject Refractory epilepsy en
dc.title Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Integrated analysis of pooled data from double-blind phase III clinical studies en
dc.type Artigo
dc.rights.license http://olabout.wiley.com/WileyCDA/Section/id-406071.html
dc.contributor.institution Hosp Ruber Int
dc.contributor.institution Univ Bonn
dc.contributor.institution Sahlgrens Univ Hosp
dc.contributor.institution Expt Med Res Inst
dc.contributor.institution Univ Porto
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution BIAL Portela & Ca SA
dc.contributor.institution 4Health Ltd
dc.contributor.institution Univ Coimbra
dc.contributor.institution Univ Aveiro
dc.description.affiliation Hosp Ruber Int, Dept Neurol, Madrid, Spain
dc.description.affiliation Univ Bonn, Dept Epileptol, Bonn, Germany
dc.description.affiliation Sahlgrens Univ Hosp, Dept Clin Neurosci & Physiol, S-41345 Gothenburg, Sweden
dc.description.affiliation Expt Med Res Inst, Budapest, Hungary
dc.description.affiliation Univ Porto, Hosp Santo Antonio, Porto Hosp Ctr, Dept Cent Nervous Syst & Senses Organs, P-4100 Oporto, Portugal
dc.description.affiliation Univ Porto, Abel Salazar Biomed Sci Inst, P-4100 Oporto, Portugal
dc.description.affiliation Universidade Federal de São Paulo, Paulista Med Sch, Neurol Studies Ctr, São Paulo, Brazil
dc.description.affiliation BIAL Portela & Ca SA, Dept Res & Dev, S Mamede Do Coronado, Portugal
dc.description.affiliation 4Health Ltd, Cantanhede, Portugal
dc.description.affiliation Univ Coimbra, Fac Pharm, Coimbra, Portugal
dc.description.affiliation Univ Aveiro, Hlth Sci Sect, P-3800 Aveiro, Portugal
dc.description.affiliation Univ Porto, Fac Med, Dept Pharmacol & Therapeut, P-4100 Oporto, Portugal
dc.description.affiliationUnifesp Universidade Federal de São Paulo, Paulista Med Sch, Neurol Studies Ctr, São Paulo, Brazil
dc.identifier.doi 10.1111/j.1528-1167.2012.03605.x
dc.description.source Web of Science
dc.identifier.wos WOS:000313116500017



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