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.authorGil-Nagel, Antonio
dc.contributor.authorElger, Christian
dc.contributor.authorBen-Menachem, Elinor
dc.contributor.authorHalasz, Peter
dc.contributor.authorLopes-Lima, Jose
dc.contributor.authorGabbai, Alberto Alain [UNIFESP]
dc.contributor.authorNunes, Teresa
dc.contributor.authorFalcao, Amilcar
dc.contributor.authorAlmeida, Luis
dc.contributor.authorSoares-da-Silva, Patricio
dc.contributor.institutionHospital Ruber Internacional
dc.contributor.institutionUniversity of Bonn
dc.contributor.institutionSahlgrenska University Hospital
dc.contributor.institutionInstitute for Experimental Medical Research
dc.contributor.institutionUniversidade do Porto
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionBIAL Portela & Ca SA
dc.contributor.institution4Health
dc.contributor.institutionUniversidade de Coimbra
dc.contributor.institutionUniversidade de Aveiro
dc.date.accessioned2016-01-24T14:30:51Z
dc.date.available2016-01-24T14:30:51Z
dc.date.issued2013-01-01
dc.description.abstractPurpose: 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.affiliationHosp Ruber Int, Dept Neurol, Madrid, Spain
dc.description.affiliationUniv Bonn, Dept Epileptol, Bonn, Germany
dc.description.affiliationSahlgrens Univ Hosp, Dept Clin Neurosci & Physiol, S-41345 Gothenburg, Sweden
dc.description.affiliationExpt Med Res Inst, Budapest, Hungary
dc.description.affiliationUniv Porto, Hosp Santo Antonio, Porto Hosp Ctr, Dept Cent Nervous Syst & Senses Organs, P-4100 Oporto, Portugal
dc.description.affiliationUniv Porto, Abel Salazar Biomed Sci Inst, P-4100 Oporto, Portugal
dc.description.affiliationUniversidade Federal de São Paulo, Paulista Med Sch, Neurol Studies Ctr, São Paulo, Brazil
dc.description.affiliationBIAL Portela & Ca SA, Dept Res & Dev, S Mamede Do Coronado, Portugal
dc.description.affiliation4Health Ltd, Cantanhede, Portugal
dc.description.affiliationUniv Coimbra, Fac Pharm, Coimbra, Portugal
dc.description.affiliationUniv Aveiro, Hlth Sci Sect, P-3800 Aveiro, Portugal
dc.description.affiliationUniv Porto, Fac Med, Dept Pharmacol & Therapeut, P-4100 Oporto, Portugal
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Paulista Med Sch, Neurol Studies Ctr, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent98-107
dc.identifierhttp://dx.doi.org/10.1111/j.1528-1167.2012.03605.x
dc.identifier.citationEpilepsia. Hoboken: Wiley-Blackwell, v. 54, n. 1, p. 98-107, 2013.
dc.identifier.doi10.1111/j.1528-1167.2012.03605.x
dc.identifier.issn0013-9580
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/35667
dc.identifier.wosWOS:000313116500017
dc.language.isoeng
dc.publisherWiley-Blackwell
dc.relation.ispartofEpilepsia
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.licensehttp://olabout.wiley.com/WileyCDA/Section/id-406071.html
dc.subjectAdjunctive therapyen
dc.subjectAdultsen
dc.subjectAntiepileptic drugsen
dc.subjectEslicarbazepine acetateen
dc.subjectPartial-onset seizuresen
dc.subjectRefractory epilepsyen
dc.titleEfficacy 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 studiesen
dc.typeinfo:eu-repo/semantics/article
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