V Villanueva1, P Bermejo2, J Montoya3, M Toledo4, A Gómez-Ibáñez1, M Garcés1, L Vilella4, F J López-González5, X Rodriguez-Osorio5, D Campos6, P Martínez7, P Giner8, J Zurita9, J Rodríguez-Uranga10, J Ojeda11, J A Mauri12, J L Camacho12, J Ruiz-Giménez13, J J Poza14, A Massot-Tarrús15, M L Galiano15, M Bonet16. 1. Hospital Universitario y Politécnico La Fe, Valencia, Spain. 2. Hospital Universitario Puerta Hierro, Madrid, Spain. 3. Hospital Lluis Alcanyis, Xátiva, Spain. 4. Hospital Universitario Vall d'Hebron, Barcelona, Spain. 5. Hospital Clinico Universitario, Santiago, Spain. 6. Hospital Clínico Universitario, Valladolid, Spain. 7. Hospital Universitario Virgen del Rocio, Sevilla, Spain. 8. Hospital Universitario Dr. Peset, Valencia, Spain. 9. Hospital Universitario Infanta Leonor, Madrid, Spain. 10. Clínica Sagrado Corazón, Instituto de Especialidades Neurológicas, Sevilla, Spain. 11. Hospital Universitario Infanta Sofía, Madrid, Spain. 12. Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain. 13. Hospital Universitario Virgen de las Nieves, Granada, Spain. 14. Hospital Universitario Donosti, San Sebastian, Spain. 15. Hospital Universitario Gregorio Marañon, Madrid, Spain. 16. Hospital Arnau de Vilanova, Valencia, Spain.
Abstract
PURPOSE: Evaluate real-life experience with eslicarbazepine acetate (ESL) after first monotherapy failure in a large series of patients with focal epilepsy. METHOD: Multicentre, retrospective, 1-year, observational study in patients older than 18 years, with focal epilepsy, who had failed first antiepileptic drug monotherapy and who received ESL. Data from clinical records were analysed at baseline, 3, 6 and 12 months to assess effectiveness and tolerability. RESULTS: Eslicarbazepine acetate was initiated in 253 patients. The 1-year retention rate was 92.9%, and the final median dose of ESL was 800 mg. At 12 months, 62.3% of patients had been seizure free for 6 months; 37.3% had been seizure free for 1 year. During follow-up, 31.6% of the patients reported ESL-related adverse events (AEs), most commonly somnolence (8.7%) and dizziness (5.1%), and 3.6% discontinued due to AEs. Hyponatraemia was observed in seven patients (2.8%). After starting ESL, 137 patients (54.2%) withdrew the prior monotherapy and converted to ESL monotherapy; 75.9% were seizure free, 87.6% were responders, 4.4% worsened, and 23.4% reported ESL-related AEs. CONCLUSION: Use of ESL after first monotherapy failure was associated with an optimal seizure control and tolerability profile. Over half of patients were converted to ESL monotherapy during follow-up.
PURPOSE: Evaluate real-life experience with eslicarbazepine acetate (ESL) after first monotherapy failure in a large series of patients with focal epilepsy. METHOD: Multicentre, retrospective, 1-year, observational study in patients older than 18 years, with focal epilepsy, who had failed first antiepileptic drug monotherapy and who received ESL. Data from clinical records were analysed at baseline, 3, 6 and 12 months to assess effectiveness and tolerability. RESULTS:Eslicarbazepine acetate was initiated in 253 patients. The 1-year retention rate was 92.9%, and the final median dose of ESL was 800 mg. At 12 months, 62.3% of patients had been seizure free for 6 months; 37.3% had been seizure free for 1 year. During follow-up, 31.6% of the patients reported ESL-related adverse events (AEs), most commonly somnolence (8.7%) and dizziness (5.1%), and 3.6% discontinued due to AEs. Hyponatraemia was observed in seven patients (2.8%). After starting ESL, 137 patients (54.2%) withdrew the prior monotherapy and converted to ESL monotherapy; 75.9% were seizure free, 87.6% were responders, 4.4% worsened, and 23.4% reported ESL-related AEs. CONCLUSION: Use of ESL after first monotherapy failure was associated with an optimal seizure control and tolerability profile. Over half of patients were converted to ESL monotherapy during follow-up.
Authors: Soujanya Sunkaraneni; Julie A Passarell; Elizabeth A Ludwig; Jill Fiedler-Kelly; Janet K Pitner; Todd A Grinnell; David Blum Journal: Clin Pharmacol Date: 2017-06-27