Abstracts

PROSPECTIVE POST-AUTHORIZATION OBSERVATIONAL STUDY OF ESLICARBAZEPINE (ESL) IN THE TREATMENT OF PHARMACORESISTANT EPILEPSIES

Abstract number : 2.200
Submission category : 7. Antiepileptic Drugs
Year : 2012
Submission ID : 16076
Source : www.aesnet.org
Presentation date : 11/30/2012 12:00:00 AM
Published date : Sep 6, 2012, 12:16 PM

Authors :
R. A. Rocamora, A. Massot, R. Vivanco, A. Principe, J. Roquer

Rationale: Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) analogue to carbamazepine (CBZ) and oxcarbazepine (OXC) authorized as add-on therapy in focal pharmacoresistant epilepsies. ESL was introduced in Spain in January 2011. The aim of this study is to analyze the efficacy, adverse-events profile, used dosage, early retention rate and combinations with other AEDs. Furthermore, in a subgroup of patients, the overnight switch from CBZ and OXC to ESL was evaluated. Methods: 61 patients with a broad spectrum of pharmacoresistant epilepsies were prospectively evaluated after the beginning of ESL therapy. The initiation of ESL was performed both in an in-patient fashion and in the outpatient's clinic. The overnight switch from CBZ and OXC was carried-out in an equivalence of 1:1,3 and 1:1 respectively during a VEEG monitoring. Results: 19 male and 42 female patients were included in the observational study. The average age was 43 y.o. (SD 14.4). The median follow-up period was 4 months (range 1,5-8). The most frequent epilepsy class was temporal lobe epilepsy (TLE) (62,3%), malformations of cortical development (13,1%) and secondary to traumatic brain injury (9,8%). The average seizure frequency was 18,9 seizures/month. 12 patients were treated with 400 mg ESL (19,7%); 26 with 800 mg (42,6%); 15 with 1200 mg (24,6%) and 8 with 1600 mg (13,1%). The seizure frequency variation was evaluated at 3 months in a subgroup of 40 patients. The average seizure frequency dropped from 22 to 9 seizures/month. 5 patients were seizure-free (12,5%), 12 (30%) had a reduction ≥ 80%, 6 patients (15%) showed a reduction of 50%, 5 (12,5%) presented a reduction of 30%, 5 patients (12,5%) reported no changes and 7 got worse (17,5%). The most important AEs were unsteadiness, dizziness and nausea (31,1%), cognitive and mood complaints (9,8%) and sleep disorders (16,4%). Of the AEs, 54,3% appeared only during the titration phase. Two skin allergic reactions were reported and in 8 cases a mild hyponatremia were detected. The early retention rate at 3 months was 75,4%. The switch from CBZ or OXC to ESL was conducted in 25 cases. In all cases, AEs were well tolerated and transitory (61,5% and 33% respectively). 3 months after the switch, 9 out of 19 (47%) showed an improvement in seizure frequency. Conclusions: ESL shows a positive efficacy in the treatment of focal epilepsies with a early retention rate > 70%. The AE profile occurs during the titration phase and is modulated by the associated AEDs. The overnight switch from CBZ and OXC to ESL could be performed in a safe manner.
Antiepileptic Drugs