Abstracts

Oxcarbazepine, a [ldquo]second generation[rdquo] antiepileptic drug, was introduced to the United States in 2000, with FDA approval in monotherapy as well as adjunctive therapy in both children over the age of 3 and adults , with partial seizures, with or without secondary generalization. The purpose of this abstract is to report the efficacy and tolerability of oxcarbazepine monotherapy collected prospectively in pediatric patients under the age of 16. Data was collected prospectively in patients with partial seizures with or without secondary generalization. Data was recorded on a standard database beginning at oxcarbazepine initiation and at 3 month intervals. Oxcarbazepine blood levels were recorded as part of routine visit in most cases. Serum sodium levels were routinely checked at three monthly intervals. Seizure frequency changes were recorded at each visit, as well as assessment of adverse effects. Eighteen patients (8 females, 10 males) ages 3-16 years were identified as treated with oxcarbazepine monotherapy. Two patients were lost to follow up and one additional patient demonstrated poor compliance. These three patients are therefore not reflected in the data analyses. Patients with less than 3 month exposure (n=2) to oxcarbazepine were also not included. Ten patients were newly diagnosed and na[iuml]ve to medication. Two patients had experienced seizures in the past but had been off medication for, 2 and 5 years respectively. Three patients were converted from carbamazepine to oxcarbazepine. In terms of tolerability, only one patient (8%) with previous drug exposure, discontinued oxcarbazepine secondary to an adverse effect (drowsiness). There was no recorded incidence of hyponatremia. Three patients had a 3 month exposure, five had 6 month exposure, one with 9 month exposure, two with 1 year exposure, and one with 4 year exposure (N=12). Two patients (16%) experienced 75-99% reduction in seizures (3 and 6 months exposure respectively). The remaining patients (84%) are seizure free. The mean oxcarbazepine dose used was 18.3 mg/kg/day (range 9.6- 42 mg/kg/day). Plasma levels were obtained and ranged from 9.3-20 [mu]g/ml. Oxcarbazepine as monotherapy, has shown outstanding efficacy and tolerability in this cohort of patients aged 3- 16 years with partial seizures, with or without secondary generalization. 84% were seizure free on monotherapy. 16% demonstrated 75-99% reduction in seizure frequency at initial dosing. The incidence of adverse effects was low and there was no recorded incidence of hyponatremia. Data collection continues and will be added to the database.