V Villanueva1, J M Serratosa2, E Guillamón3, M Garcés3, B G Giráldez2, M Toledo4, J Salas-Puig4, F J López González5, J Flores6, J Rodríguez-Uranga7, A Castillo8, J A Mauri9, J L Camacho9, E López-Gomáriz10, P Giner11, N Torres11, J Palau12, A Molins13. 1. Hospital Universitario y Politécnico La Fe, Valencia, Spain. Electronic address: villanueva_vichab@gva.es. 2. Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain. 3. Hospital Universitario y Politécnico La Fe, Valencia, Spain. 4. Hospital Universitario Vall d́Hebron, Barcelona, Spain. 5. Complejo Hospitalario Universitario Santiago, Santiago de Compostela, Spain. 6. Hospital Universitario Nuestra Señora Candelaria, Tenerife, Spain. 7. Instituto de Especialidades Neurológicas (IENSA), Clinica Sagrado Corazón, Sevilla, Spain. 8. Consorcio Hospital General Universitario Valencia, Valencia, Spain. 9. Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. 10. Hospital Lluis Alcanyis, Xàtiva, Spain. 11. Hospital Universitario, Dr. Peset, Valencia, Spain. 12. Hospital de Manises, Manises, Spain. 13. Hospital Universitario Dr. JosepTrueta, Girona, Spain.
Abstract
BACKGROUND: Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) licensed as adjunctive therapy in adults with partial-onset or focal seizures. OBJECTIVE: To evaluate in a clinical practice setting the long-term efficacy and safety of ESL in patients with focal seizures. METHODS: ESLIBASE was a retrospective study that included all patients with focal seizures who started ESL between January 2010 and July 2012 at 12 hospitals. ESL was prescribed individually according to real-life practice. Efficacy and safety were evaluated over 1 year. Switching from carbamazepine (CBZ) and oxcarbazepine (OXC) was assessed. RESULTS: Three hundred and twenty-seven patients were included; 78% of patients were taking ≥2 other AEDs at baseline. Most (87%) began ESL because of poor seizure control and 13% because of adverse events (AEs) with CBZ or OXC. After 1 year, 237 patients (72.4%) remained on ESL. At 3, 6 and 12 months, the responder rate was 46.3%, 57.9%, and 52.5%, and 21.0%, 28.0%, and 25.3% of patients were seizure free. The responder rate significantly increased when ESL was combined with a non-sodium channel-targeting drug (non-SC drug) (66.7%) versus an SC drug (47.7%; p<0.001). At 12 months, 40.7% of patients had ≥1 AE; AEs led to treatment discontinuation in 16.2%. Dizziness, nausea, and somnolence were the most common AEs. The tolerability profile improved in >50% of the patients who switched from CBZ or OXC to ESL because of AEs. CONCLUSIONS: ESL was well tolerated and effective in a real-world setting over 1 year. Side-effect profile improved when OXC and CBZ recipients were switched to ESL.
BACKGROUND:Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) licensed as adjunctive therapy in adults with partial-onset or focal seizures. OBJECTIVE: To evaluate in a clinical practice setting the long-term efficacy and safety of ESL in patients with focal seizures. METHODS: ESLIBASE was a retrospective study that included all patients with focal seizures who started ESL between January 2010 and July 2012 at 12 hospitals. ESL was prescribed individually according to real-life practice. Efficacy and safety were evaluated over 1 year. Switching from carbamazepine (CBZ) and oxcarbazepine (OXC) was assessed. RESULTS: Three hundred and twenty-seven patients were included; 78% of patients were taking ≥2 other AEDs at baseline. Most (87%) began ESL because of poor seizure control and 13% because of adverse events (AEs) with CBZ or OXC. After 1 year, 237 patients (72.4%) remained on ESL. At 3, 6 and 12 months, the responder rate was 46.3%, 57.9%, and 52.5%, and 21.0%, 28.0%, and 25.3% of patients were seizure free. The responder rate significantly increased when ESL was combined with a non-sodium channel-targeting drug (non-SC drug) (66.7%) versus an SC drug (47.7%; p<0.001). At 12 months, 40.7% of patients had ≥1 AE; AEs led to treatment discontinuation in 16.2%. Dizziness, nausea, and somnolence were the most common AEs. The tolerability profile improved in >50% of the patients who switched from CBZ or OXC to ESL because of AEs. CONCLUSIONS:ESL was well tolerated and effective in a real-world setting over 1 year. Side-effect profile improved when OXC and CBZ recipients were switched to ESL.