Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study
Autor(a) principal: | |
---|---|
Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.16/2592 |
Resumo: | 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. |
id |
RCAP_420610b020a9e2296d7381ee2c46a60f |
---|---|
oai_identifier_str |
oai:repositorio.chporto.pt:10400.16/2592 |
network_acronym_str |
RCAP |
network_name_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository_id_str |
7160 |
spelling |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension studyantiseizure medicationcarbamazepinefocal seizuresresponder rateretentionseizure freedom rateObjective: 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.Blackwell ScienceRepositório Científico do Centro Hospitalar Universitário de Santo AntónioTrinka, EugenRocamora, RodrigoChaves, JoãoMoreira, JoanaIkedo, FábioSoares‐da‐Silva, PatrícioEstol, ConradoNewton, MarkCarne, RossKowacs, PedroPetrova, DorinaSyankov, DimitarMaslarov, DimitarStanev, SlaviLasso, JorgeBašić, SilvioBar, MichalVyskočilová, DanaPazdera, LadislavHaldre, SulevKaarina Kälviäinen, ReettaPeltola, JukkaGeorges Maillard, LouisDeckert‐Schmitz, MariaSpringub, JoachimBarcs, GáborMénes, AndreaTóth, MariannaGiallonardo, Anna TeresaPaganini, MarcoAsmane, SantaLogina, LnaraMeilute Lescinskiene, LoretaCruz, AnaUmeres, HugoCzapiński, PiotrTrzebińska‐Frydrychowska, EwaSales, FranciscoFalup‐Pecurariu, Cristian GavrilSilviu Manescu, EmilianRoceanu, Adina‐MariaOdinak, MiroslavTretyakova, EvgeniyaVolkova, LarisaLebedeva, AnnaLipatova, LiudmilaBogdanov, EnverVladimirovna Polezhaeva, TatianaGebauer‐Bukurov, KsenijaJovanovic‐Mihajlovic, NatalijaMilovanovic, MajaSpasic, MirjanaLipovský, L'UbomírPerichtová, MagdalénaChamilová, JanaBalaguer, ErnestUgarte, AntonioDubenko, AndriyKharchuk, SergiiMoroz, SvitlanaShkrobot, SvitlanaMar'yenko, LidiyaLitovchenko, TetyanaCock, Hannah2021-11-22T13:48:02Z20202020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.16/2592engTrinka 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.166660013-958010.1111/epi.16666info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-10-20T11:01:12Zoai:repositorio.chporto.pt:10400.16/2592Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T20:38:47.488306Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
title |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
spellingShingle |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study Trinka, Eugen antiseizure medication carbamazepine focal seizures responder rate retention seizure freedom rate |
title_short |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
title_full |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
title_fullStr |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
title_full_unstemmed |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
title_sort |
Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study |
author |
Trinka, Eugen |
author_facet |
Trinka, Eugen Rocamora, Rodrigo Chaves, João Moreira, Joana Ikedo, Fábio Soares‐da‐Silva, Patrício Estol, Conrado Newton, Mark Carne, Ross Kowacs, Pedro Petrova, Dorina Syankov, Dimitar Maslarov, Dimitar Stanev, Slavi Lasso, Jorge Bašić, Silvio Bar, Michal Vyskočilová, Dana Pazdera, Ladislav Haldre, Sulev Kaarina Kälviäinen, Reetta Peltola, Jukka Georges Maillard, Louis Deckert‐Schmitz, Maria Springub, Joachim Barcs, Gábor Ménes, Andrea Tóth, Marianna Giallonardo, Anna Teresa Paganini, Marco Asmane, Santa Logina, Lnara Meilute Lescinskiene, Loreta Cruz, Ana Umeres, Hugo Czapiński, Piotr Trzebińska‐Frydrychowska, Ewa Sales, Francisco Falup‐Pecurariu, Cristian Gavril Silviu Manescu, Emilian Roceanu, Adina‐Maria Odinak, Miroslav Tretyakova, Evgeniya Volkova, Larisa Lebedeva, Anna Lipatova, Liudmila Bogdanov, Enver Vladimirovna Polezhaeva, Tatiana Gebauer‐Bukurov, Ksenija Jovanovic‐Mihajlovic, Natalija Milovanovic, Maja Spasic, Mirjana Lipovský, L'Ubomír Perichtová, Magdaléna Chamilová, Jana Balaguer, Ernest Ugarte, Antonio Dubenko, Andriy Kharchuk, Sergii Moroz, Svitlana Shkrobot, Svitlana Mar'yenko, Lidiya Litovchenko, Tetyana Cock, Hannah |
author_role |
author |
author2 |
Rocamora, Rodrigo Chaves, João Moreira, Joana Ikedo, Fábio Soares‐da‐Silva, Patrício Estol, Conrado Newton, Mark Carne, Ross Kowacs, Pedro Petrova, Dorina Syankov, Dimitar Maslarov, Dimitar Stanev, Slavi Lasso, Jorge Bašić, Silvio Bar, Michal Vyskočilová, Dana Pazdera, Ladislav Haldre, Sulev Kaarina Kälviäinen, Reetta Peltola, Jukka Georges Maillard, Louis Deckert‐Schmitz, Maria Springub, Joachim Barcs, Gábor Ménes, Andrea Tóth, Marianna Giallonardo, Anna Teresa Paganini, Marco Asmane, Santa Logina, Lnara Meilute Lescinskiene, Loreta Cruz, Ana Umeres, Hugo Czapiński, Piotr Trzebińska‐Frydrychowska, Ewa Sales, Francisco Falup‐Pecurariu, Cristian Gavril Silviu Manescu, Emilian Roceanu, Adina‐Maria Odinak, Miroslav Tretyakova, Evgeniya Volkova, Larisa Lebedeva, Anna Lipatova, Liudmila Bogdanov, Enver Vladimirovna Polezhaeva, Tatiana Gebauer‐Bukurov, Ksenija Jovanovic‐Mihajlovic, Natalija Milovanovic, Maja Spasic, Mirjana Lipovský, L'Ubomír Perichtová, Magdaléna Chamilová, Jana Balaguer, Ernest Ugarte, Antonio Dubenko, Andriy Kharchuk, Sergii Moroz, Svitlana Shkrobot, Svitlana Mar'yenko, Lidiya Litovchenko, Tetyana Cock, Hannah |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Repositório Científico do Centro Hospitalar Universitário de Santo António |
dc.contributor.author.fl_str_mv |
Trinka, Eugen Rocamora, Rodrigo Chaves, João Moreira, Joana Ikedo, Fábio Soares‐da‐Silva, Patrício Estol, Conrado Newton, Mark Carne, Ross Kowacs, Pedro Petrova, Dorina Syankov, Dimitar Maslarov, Dimitar Stanev, Slavi Lasso, Jorge Bašić, Silvio Bar, Michal Vyskočilová, Dana Pazdera, Ladislav Haldre, Sulev Kaarina Kälviäinen, Reetta Peltola, Jukka Georges Maillard, Louis Deckert‐Schmitz, Maria Springub, Joachim Barcs, Gábor Ménes, Andrea Tóth, Marianna Giallonardo, Anna Teresa Paganini, Marco Asmane, Santa Logina, Lnara Meilute Lescinskiene, Loreta Cruz, Ana Umeres, Hugo Czapiński, Piotr Trzebińska‐Frydrychowska, Ewa Sales, Francisco Falup‐Pecurariu, Cristian Gavril Silviu Manescu, Emilian Roceanu, Adina‐Maria Odinak, Miroslav Tretyakova, Evgeniya Volkova, Larisa Lebedeva, Anna Lipatova, Liudmila Bogdanov, Enver Vladimirovna Polezhaeva, Tatiana Gebauer‐Bukurov, Ksenija Jovanovic‐Mihajlovic, Natalija Milovanovic, Maja Spasic, Mirjana Lipovský, L'Ubomír Perichtová, Magdaléna Chamilová, Jana Balaguer, Ernest Ugarte, Antonio Dubenko, Andriy Kharchuk, Sergii Moroz, Svitlana Shkrobot, Svitlana Mar'yenko, Lidiya Litovchenko, Tetyana Cock, Hannah |
dc.subject.por.fl_str_mv |
antiseizure medication carbamazepine focal seizures responder rate retention seizure freedom rate |
topic |
antiseizure medication carbamazepine focal seizures responder rate retention seizure freedom rate |
description |
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. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020 2020-01-01T00:00:00Z 2021-11-22T13:48:02Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.16/2592 |
url |
http://hdl.handle.net/10400.16/2592 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Trinka 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.16666 0013-9580 10.1111/epi.16666 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Blackwell Science |
publisher.none.fl_str_mv |
Blackwell Science |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
repository.mail.fl_str_mv |
|
_version_ |
1799133648426893312 |