Abstracts

Rationale: Lacosamide (LCM) was approved in 2008 by the EMEA and the FDA as add-on treatment for patients 16 years and older with uncontrolled focal onset seizures. There is still limited data available concerning (long-term) effectivity and safety in patients <16 years of age. Methods: Pooled data from a retrospective chart review performed by four paediatric epilepsy centres in middle Europe were analysed for this report. Screened were all patients with drug resistant focal epilepsy with/without secondary generalization and treated with add-on LCM. Included in the final analysis were those who fulfilled the following inclusion criteria: age <16 years at treatment initiation and a treatment duration of at least 12 months. Outcome (compared to baseline = the year prior to treatment initiation) was assessed at an annual basis and at time of last observation. Statistics was descriptive.Results: 64 patients were identified, 23 patients did not fulfil the inclusion criteria (lack of efficacy, seizure aggravation and/or side effects prompted discontinuation. Therefore, the observation period was <12 months). 41 patients (29 boys; mean age 10.9 years, range 5-16 years) were finally analysed. The median duration of epilepsy before LCM treatment was 3.8 years (range 4.4 months 15.8 years). Patients were receiving a median of 2 concomitant antiepileptic drugs (range 1-3). LCM doses ranged between 1.7 and 10.5 mg/kg/day. The mean treatment duration was 18 months (range 13-46months). Median seizure frequency at baseline was 58 (range 24-684). The reported greater than 50% reduction in seizure frequency was 39% at 12 months and 28% at last assessment. Seizure freedom (of at least 12 months) was seen in 10%. Side effects (mostly mild, primarily somnolence and irritability), were reported by 35% of patients. Conclusions: Our data suggest that LCM long-term treatment in pediatric patients with difficult to treat focal epilepsies to be safe at doses up to 10 mg/kg/day without any major side effects. As severe seizure aggravation was seen shortly after initiation of the drug in 2 patients (later diagnosed as primary generalised epilepsy and Dravet syndrome), LCM should be used with extreme caution when syndrome diagnosis is unclear. The authors report no conflicts of interest in this work