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

2020Journal article Open access
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dc.contributor.authorTrinka, Eugen
dc.contributor.authorRocamora, Rodrigo
dc.contributor.authorChaves, João
dc.contributor.authorMoreira, Joana
dc.contributor.authorIkedo, Fábio
dc.contributor.authorSoares‐da‐Silva, Patrício
dc.contributor.authorEstol, Conrado
dc.contributor.authorNewton, Mark
dc.contributor.authorCarne, Ross
dc.contributor.authorKowacs, Pedro
dc.contributor.authorPetrova, Dorina
dc.contributor.authorSyankov, Dimitar
dc.contributor.authorMaslarov, Dimitar
dc.contributor.authorStanev, Slavi
dc.contributor.authorLasso, Jorge
dc.contributor.authorBašić, Silvio
dc.contributor.authorBar, Michal
dc.contributor.authorVyskočilová, Dana
dc.contributor.authorPazdera, Ladislav
dc.contributor.authorHaldre, Sulev
dc.contributor.authorKaarina Kälviäinen, Reetta
dc.contributor.authorPeltola, Jukka
dc.contributor.authorGeorges Maillard, Louis
dc.contributor.authorDeckert‐Schmitz, Maria
dc.contributor.authorSpringub, Joachim
dc.contributor.authorBarcs, Gábor
dc.contributor.authorMénes, Andrea
dc.contributor.authorTóth, Marianna
dc.contributor.authorGiallonardo, Anna Teresa
dc.contributor.authorPaganini, Marco
dc.contributor.authorAsmane, Santa
dc.contributor.authorLogina, Lnara
dc.contributor.authorMeilute Lescinskiene, Loreta
dc.contributor.authorCruz, Ana
dc.contributor.authorUmeres, Hugo
dc.contributor.authorCzapiński, Piotr
dc.contributor.authorTrzebińska‐Frydrychowska, Ewa
dc.contributor.authorSales, Francisco
dc.contributor.authorFalup‐Pecurariu, Cristian Gavril
dc.contributor.authorSilviu Manescu, Emilian
dc.contributor.authorRoceanu, Adina‐Maria
dc.contributor.authorOdinak, Miroslav
dc.contributor.authorTretyakova, Evgeniya
dc.contributor.authorVolkova, Larisa
dc.contributor.authorLebedeva, Anna
dc.contributor.authorLipatova, Liudmila
dc.contributor.authorBogdanov, Enver
dc.contributor.authorVladimirovna Polezhaeva, Tatiana
dc.contributor.authorGebauer‐Bukurov, Ksenija
dc.contributor.authorJovanovic‐Mihajlovic, Natalija
dc.contributor.authorMilovanovic, Maja
dc.contributor.authorSpasic, Mirjana
dc.contributor.authorLipovský, L'Ubomír
dc.contributor.authorPerichtová, Magdaléna
dc.contributor.authorChamilová, Jana
dc.contributor.authorBalaguer, Ernest
dc.contributor.authorUgarte, Antonio
dc.contributor.authorDubenko, Andriy
dc.contributor.authorKharchuk, Sergii
dc.contributor.authorMoroz, Svitlana
dc.contributor.authorShkrobot, Svitlana
dc.contributor.authorMar'yenko, Lidiya
dc.contributor.authorLitovchenko, Tetyana
dc.contributor.authorCock, Hannah
dc.date.accessioned2021-11-22T13:48:02Z
dc.date.available2021-11-22T13:48:02Z
dc.date.issued2020
dc.description.abstractObjective: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationTrinka E, Rocamora R, Chaves J, et al. 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):2129-2141. doi:10.1111/epi.16666pt_PT
dc.identifier.doi10.1111/epi.16666pt_PT
dc.identifier.issn0013-9580
dc.identifier.issn1528-1167
dc.identifier.urihttp://hdl.handle.net/10400.16/2592
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBlackwell Sciencept_PT
dc.relation.publisherversionhttps://onlinelibrary.wiley.com/doi/10.1111/epi.16666pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/pt_PT
dc.subjectantiseizure medicationpt_PT
dc.subjectcarbamazepinept_PT
dc.subjectfocal seizurespt_PT
dc.subjectresponder ratept_PT
dc.subjectretentionpt_PT
dc.subjectseizure freedom ratept_PT
dc.titleLong‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceUnited States of Americapt_PT
oaire.citation.endPage2141pt_PT
oaire.citation.issue10pt_PT
oaire.citation.startPage2129pt_PT
oaire.citation.titleEpilepsiapt_PT
oaire.citation.volume61pt_PT
person.familyNameChaves
person.givenNameJoão
person.identifier.orcid0000-0003-4454-5232
person.identifier.scopus-author-id12446353200
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationf6b7b8da-41ec-4fbc-a585-5880bd973ca4
relation.isAuthorOfPublication.latestForDiscoveryf6b7b8da-41ec-4fbc-a585-5880bd973ca4

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