A Spanish collection of patients with Eslicarbazepine in clinical practice

1. A Spanish collection of patients with Eslicarbazepine in clinical practice Serratosa J.1, GuillamónE.2, López-Gomáriz E.3, Toledo M.4, Salas J.4, Flores J.5, Rodríguez Uranga J6, LópezF.7, CastilloA.8, Mauri J.9, GinerP.10, Torres N.10, Palau J.11, Molins A.12, Garcés M.2, González GiráldezB.1, Villanueva V.2 1Fundación Jiménez Díaz, Madrid; 2HUP la Fe, Valencia; 3H. Lluís Alcanyís, Xàtiva; 4H. Vall d´Ebron, Barcelona; 5H. Nuestra Señora de Candelaria, Santa Cruz de Tenerife; 6IENSA Sagrado Corazón, Sevilla; 7Complejo Hospitalario Universitario de Santiago, Santiago de Compostela; 8CH. General, Valencia; 9HCU Lozano Blesa, Zaragoza; 10H. Peset, Valencia; 11H. Manises, Valencia; 12HC Josep Trueta, Girona. SPAIN • TOLERABILITY: Profile of adverse effects • A 40.67% of patients experienced adverse effects at 12 months, of which 14.9% led to the withdrawal. • The most frequent adverse effects during the observation period were dizziness / sickness (11.3%) and sleepiness (6.1%). • Tolerability on CBZ/OXC that switched because of side-effects: ANALYSIS OF EFFECTIVENESS: • RATIONALE: • Eslicarbazepine acetate (ESL) is a novel voltage-gated sodium channel blocker authorized as add-on therapy in adults with partial onset seizures (POS) with or without secondary generalization. The aim of this study is to evaluate the efficacy and safety of ESL in a Spanish sample of patients with refractory POS in daily clinical practice. • Study variables analyzed: • Efficacy variables: Proportion of patients seizure-free, responders and retention rate at 3,6 and 12 months. Effectiveness in relation to baseline characteristics (type of epilepsy and etiology). • Safety variables: Proportion of patients with adverse effects at 3, 6 and 12 months. • Efficacy variables were compared between drugs sodium channel blockers (SCB +) and drugs non-sodium channel blockers (SCB -). Baseline 327 patientsincluded 35 patientswithdrwan 26-side effects 9- lack of efficacy 3 monthsvisit 292 patients (89.3%) 30 patientswithdrawn 18-side effects 12-lack of efficacy • STUDY DESIGN: • ESLIBASE is a multicenter retrospective, observational collection of patients with partial epilepsy who started treatment with ESL after February 2011, based on clinical practice. Data were retrospectively collected in clinical charts of patients in 12 hospitals in Spain. • Inclusion criteria: • Diagnosis of partial epilepsy. • Patients suitable for the initiation of treatment with ESL according to participating physicians as clinical practice. • Data collected: • Baseline (demographic and epilepsy data, seizure type, epilepsy syndrome, etiology, age of onset, concomitant and prior antiepileptic drugs (AED), number of seizures. • Visit at 3, 6 and 12 months after starting treatment (dose and titration of ESL, number of seizures and efficacy, adverse effects, concomitant AED, doses and combinations. 6 monthsvisit 262 patients (80.1%) 25 patientswithdrawn 5-side effects 10-lack of efficacy 12 months visit 237 patients (72.4%) Efficacy as combination SCB (+)/(-) AED: • RESULTS: • Three hundred and twenty-seven patients were included. • From the series 91.13% of patients had previously taken at least 2 AED. • Concomitant AEDs at baseline, the most frequent were LEV 148 patients (45%), LTG, 71 patients (21%), VPA 63patients (19.2%) and LCM 61patients (18,6%). • At baseline, 51 patients (15,5%) were taking (SCB-), 263 patients (80.4%) were taking at least one (SCB +), 13 patients (3.9%) didn´t take any concomitant AED. • Conclusions: • In our sample ESL proved to be a safe and effective drug for the treatment of partial epilepsy in clinical practice. • Side-effects improved with respect to OXC/CBZ. • The combination with non-sodium channel blocker AED showed superior efficacy. ** * * p=0,020 ** p=0,001