Long-term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open-label extension study

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  • dc.contributor.author Trinka, Eugen
  • dc.contributor.author Rocamora, Rodrigo
  • dc.contributor.author Chaves, João
  • dc.contributor.author Moreira, Joana
  • dc.contributor.author Ikedo, Fábio
  • dc.contributor.author Soares-da-Silva, Patrício
  • dc.contributor.author BIA-2093-311/EXT Investigators Study Group
  • dc.date.accessioned 2021-09-13T07:37:36Z
  • dc.date.available 2021-09-13T07:37:36Z
  • dc.date.issued 2020
  • dc.description.abstract Objective: To assess the efficacy, safety, and tolerability of eslicarbazepine acetate (ESL) monotherapy during long-term treatment. Methods: An open-label extension (OLE) study was conducted in adults completing a phase 3, randomized, double-blind, noninferiority trial, during which they had received monotherapy with either once-daily ESL or twice-daily controlled-release carbamazepine (CBZ-CR) for newly diagnosed focal epilepsy. In the OLE study, all patients received ESL (800-1600 mg/d) for 2 years. Primary efficacy outcome was retention time (from baseline of the OLE study). Secondary efficacy assessments included seizure freedom rate (no seizures during the OLE study) and responder rate (≥50% seizure frequency reduction from baseline of double-blind trial). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs). Results: Of 206 randomized patients, 96 who received ESL in the double-blind trial (ESL/ESL) and 88 who received CBZ-CR in the double-blind trial (CBZ-CR/ESL) were treated with ESL monotherapy (89.3% overall). Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time). After 24 months, the probability of ESL withdrawal was 0.0638 (95% confidence interval [CI] = 0.0292-0.1366) in the ESL/ESL group and 0.0472 (95% CI = 0.0180-0.1210) in the CBZ-CR/ESL group. Seizure freedom rates were 90.6% (ESL/ESL) and 80.7% (CBZ-CR/ESL; P = .0531). Responder rates remained >80% in both groups throughout the study. Incidence of serious TEAEs was similar between groups (7.3% vs 5.7%; 0% vs 1.1% possibly related), as were the incidences of TEAEs considered at least possibly related to treatment (17.7% vs 18.2%) and TEAEs leading to discontinuation (3.1% vs 4.5%). The types of TEAEs were generally consistent with the known safety profile of ESL. Significance: ESL monotherapy was efficacious and generally well tolerated over the long term, including in patients who transitioned from CBZ-CR monotherapy. No new safety concerns emerged.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Trinka E, Rocamora R, Chaves J, Moreira J, Ikedo F, Soares-da-Silva P; BIA-2093-311/EXT Investigators Study Group. Long-term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open-label extension study. Epilepsia. 2020;61(10):2129-41. DOI: 10.1111/epi.16666
  • dc.identifier.doi http://dx.doi.org/10.1111/epi.16666
  • dc.identifier.issn 0013-9580
  • dc.identifier.uri http://hdl.handle.net/10230/48439
  • dc.language.iso eng
  • dc.publisher Wiley
  • dc.relation.ispartof Epilepsia. 2020;61(10):2129-41
  • dc.rights © 2020 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epileps. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
  • dc.subject.keyword Antiseizure medication
  • dc.subject.keyword Carbamazepine
  • dc.subject.keyword Focal seizures
  • dc.subject.keyword Responder rate
  • dc.subject.keyword Retention
  • dc.subject.keyword Seizure freedom rate
  • dc.title Long-term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open-label extension study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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