Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results
Introduction: Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) and an analogue to carbamazepine (CBZ) and oxcarbazepine (OXC). In this study, we evaluate initial therapeutic response to ESL and events in the change from CBZ and OXC. Methods: We evaluated 61 patients with a broad spect...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier España
2014-03-01
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| Series: | Neurología (English Edition) |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2173580814000108 |
| _version_ | 1818329144897830912 |
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| author | A. Massot R. Vivanco A. Principe J. Roquer R. Rocamora |
| author_facet | A. Massot R. Vivanco A. Principe J. Roquer R. Rocamora |
| author_sort | A. Massot |
| collection | DOAJ |
| description | Introduction: Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) and an analogue to carbamazepine (CBZ) and oxcarbazepine (OXC). In this study, we evaluate initial therapeutic response to ESL and events in the change from CBZ and OXC. Methods: We evaluated 61 patients with a broad spectrum of drug-resistant epilepsies in a cross-sectional study. The switch from CBZ and OXC to ESL was carried out in a single night at ratios of 1:1.3 and 1:1 mg respectively. Results: The most common form of epilepsy was temporal lobe epilepsy (62.3%). The most common aetiology was mesial temporal sclerosis (26.2%). Mean follow-up time was 4.7 ± 3.2 months. In 40 patients with a minimum follow-up period of 3 months, monthly median seizure frequency dropped by 63.6% (P<.001) and a reduction of 80% or more was recorded in 30%. Adverse events (AEs) occurred in 54%; all appeared during the titration phase. They were more frequent at doses in excess of 800 mg (73.9% vs. 47.4%; P = .042). The most common AE was dizziness (34.4%), which was commonly associated with VPA, LTG and/or LCS consumption (19.2% vs. 45.7%; P = .031). The retention rate at 3 months was 75.4%. A total of 25 patients replaced CBZ or OXC treatment with ESL; any AEs were transient (69.2% for CBZ and 33% for OXC; P = .073). At 3 months after the treatment change, median seizure frequency had decreased by 20% (P < .075). Conclusions: ESL is effective in the treatment of focal epilepsies and its early retention rate is >70%. AEs occurred during the titration phase and corresponded to associated AEDs. A rapid change from CBZ and OXC to ESL treatment can be safely performed. Resumen: Introducción: La eslicarbazepina (ESL) es un nuevo fármaco antiepiléptico (FAE) análogo de la carbamazepina (CBZ) y la oxcarbazepina (OXC). Analizamos su respuesta terapéutica inicial y el paso desde CBZ y OXC. Métodos: Evaluamos en un estudio transversal a 61 pacientes con un amplio espectro de epilepsias farmacorresistentes. El cambio desde CBZ y OXC se realizó en una noche con una equivalencia de 1:1,3 y 1:1 mg. Resultados: La epilepsia más frecuente fue la de lóbulo temporal (62,3%). La etiología más frecuente la esclerosis mesial (26,2%). El seguimiento medio fue de 4,7 ± 3,2 meses. En 40 pacientes con seguimiento mínimo de 3 meses, la frecuencia mediana de crisis se redujo un 63,6% (p < 0,001), siendo en un 30% la reducción ≥ 80%. Los efectos adversos (EA) aparecieron en el 54,3% siempre durante la fase de titulación, siendo más frecuentes a dosis superiores a 800 mg (73,9% vs. 47,4%; p = 0,042) y el más importante el mareo (34,4%), siendo más habitual en asociación con VPA, LTG y/o LCS (19,2% vs. 45,7%; p = 0,031). La tasa de retención temprana a los 3 meses fue del 75,4%. En 25 pacientes se cambió desde CBZ o OXC, siendo los EA transitorios (69,2% y 33%; p = 0,073). Pasados 3 meses del cambio, la frecuencia mediana de crisis había disminuido un 20% (p < 0,075). Conclusiones: La ESL es eficaz en el tratamiento de epilepsias focales, con una tasa de retención temprana > 70%. Los EA tienen lugar durante la fase de titulación y según los fármamcos antiepilépticos asociados. El cambio rápido desde CBZ y OXC puede realizarse de forma segura. Keywords: Eslicarbazepine, Epilepsy, Drug-resistant, Eslicarbazepine, Carbamazepine, Oxcarbazepine, Palabras clave: Eslicarbazepina, Epilepsia, Farmacorresistente, Eslicarbazepina, Carbamazepina, Oxcarbazepina |
| first_indexed | 2024-12-13T12:43:24Z |
| format | Article |
| id | doaj.art-8364f68aa58648b185e77b4ab82d9d66 |
| institution | Directory Open Access Journal |
| issn | 2173-5808 |
| language | English |
| last_indexed | 2024-12-13T12:43:24Z |
| publishDate | 2014-03-01 |
| publisher | Elsevier España |
| record_format | Article |
| series | Neurología (English Edition) |
| spelling | doaj.art-8364f68aa58648b185e77b4ab82d9d662022-12-21T23:45:34ZengElsevier EspañaNeurología (English Edition)2173-58082014-03-0129294101Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary resultsA. Massot0R. Vivanco1A. Principe2J. Roquer3R. Rocamora4Unidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, SpainUnidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, SpainUnidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, SpainUnidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, SpainCorresponding author.; Unidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, SpainIntroduction: Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) and an analogue to carbamazepine (CBZ) and oxcarbazepine (OXC). In this study, we evaluate initial therapeutic response to ESL and events in the change from CBZ and OXC. Methods: We evaluated 61 patients with a broad spectrum of drug-resistant epilepsies in a cross-sectional study. The switch from CBZ and OXC to ESL was carried out in a single night at ratios of 1:1.3 and 1:1 mg respectively. Results: The most common form of epilepsy was temporal lobe epilepsy (62.3%). The most common aetiology was mesial temporal sclerosis (26.2%). Mean follow-up time was 4.7 ± 3.2 months. In 40 patients with a minimum follow-up period of 3 months, monthly median seizure frequency dropped by 63.6% (P<.001) and a reduction of 80% or more was recorded in 30%. Adverse events (AEs) occurred in 54%; all appeared during the titration phase. They were more frequent at doses in excess of 800 mg (73.9% vs. 47.4%; P = .042). The most common AE was dizziness (34.4%), which was commonly associated with VPA, LTG and/or LCS consumption (19.2% vs. 45.7%; P = .031). The retention rate at 3 months was 75.4%. A total of 25 patients replaced CBZ or OXC treatment with ESL; any AEs were transient (69.2% for CBZ and 33% for OXC; P = .073). At 3 months after the treatment change, median seizure frequency had decreased by 20% (P < .075). Conclusions: ESL is effective in the treatment of focal epilepsies and its early retention rate is >70%. AEs occurred during the titration phase and corresponded to associated AEDs. A rapid change from CBZ and OXC to ESL treatment can be safely performed. Resumen: Introducción: La eslicarbazepina (ESL) es un nuevo fármaco antiepiléptico (FAE) análogo de la carbamazepina (CBZ) y la oxcarbazepina (OXC). Analizamos su respuesta terapéutica inicial y el paso desde CBZ y OXC. Métodos: Evaluamos en un estudio transversal a 61 pacientes con un amplio espectro de epilepsias farmacorresistentes. El cambio desde CBZ y OXC se realizó en una noche con una equivalencia de 1:1,3 y 1:1 mg. Resultados: La epilepsia más frecuente fue la de lóbulo temporal (62,3%). La etiología más frecuente la esclerosis mesial (26,2%). El seguimiento medio fue de 4,7 ± 3,2 meses. En 40 pacientes con seguimiento mínimo de 3 meses, la frecuencia mediana de crisis se redujo un 63,6% (p < 0,001), siendo en un 30% la reducción ≥ 80%. Los efectos adversos (EA) aparecieron en el 54,3% siempre durante la fase de titulación, siendo más frecuentes a dosis superiores a 800 mg (73,9% vs. 47,4%; p = 0,042) y el más importante el mareo (34,4%), siendo más habitual en asociación con VPA, LTG y/o LCS (19,2% vs. 45,7%; p = 0,031). La tasa de retención temprana a los 3 meses fue del 75,4%. En 25 pacientes se cambió desde CBZ o OXC, siendo los EA transitorios (69,2% y 33%; p = 0,073). Pasados 3 meses del cambio, la frecuencia mediana de crisis había disminuido un 20% (p < 0,075). Conclusiones: La ESL es eficaz en el tratamiento de epilepsias focales, con una tasa de retención temprana > 70%. Los EA tienen lugar durante la fase de titulación y según los fármamcos antiepilépticos asociados. El cambio rápido desde CBZ y OXC puede realizarse de forma segura. Keywords: Eslicarbazepine, Epilepsy, Drug-resistant, Eslicarbazepine, Carbamazepine, Oxcarbazepine, Palabras clave: Eslicarbazepina, Epilepsia, Farmacorresistente, Eslicarbazepina, Carbamazepina, Oxcarbazepinahttp://www.sciencedirect.com/science/article/pii/S2173580814000108 |
| spellingShingle | A. Massot R. Vivanco A. Principe J. Roquer R. Rocamora Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results Neurología (English Edition) |
| title | Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results |
| title_full | Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results |
| title_fullStr | Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results |
| title_full_unstemmed | Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results |
| title_short | Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results |
| title_sort | post authorisation study of eslicarbazepine as treatment for drug resistant epilepsy preliminary results |
| url | http://www.sciencedirect.com/science/article/pii/S2173580814000108 |
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