Abstracts

Oxcarbazepine has proven efficacy as add-on treatment for children with partial seizures (Glauser et al, Neurology 2000;54:2237-2244). This analysis was performed to evaluate the safety and tolerability of oxcarbazepine whether given as monotherapy or adjunctive therapy.
All safety data from children ([lt]17 years of age) were evaluated from the Novartis Clinical database. The analysis of safety data was categorized by [lt]8 years of age and 8-16 years of age because of the potential for a higher clearance rate in patients [lt]8 years of age. Safety variables analyzed were treatment-emergent adverse events, deaths and serious adverse events, premature discontinuations, laboratory values, vital signs, body weight and ECG.
Data from two databases were analyzed: Clinical Development Program (CDP, n=572) and the Compassionate Use Program (n=487). Of these 1059 pediatric patients, 403 (38%) were exposed to oxcarbazepine monotherapy. Most patients received oxcarbazepine doses ranging between 10 and 60 mg/kg/day. For all pediatric patients in the CDP, the most frequent adverse events ([gt]20%) were headache, somnolence, vomiting and dizziness. For those pediatric patients receiving oxcarbazepine monotherapy, the most common adverse events were headache and somnolence. Premature discontinuations due to adverse events were similar to or lower than those observed in the adult population. Asymptomatic but clinically significant hyponatremia (Na⁺ levels [lt]125 mmol/L) was observed in only 1 patient (0.2%). No other clinically relevant changes were observed. No differences were found between the two age groups (8-16 years of age and [lt]8 years of age). Consistent data were observed in the Compassionate Use Program analysis.
Based on this analysis of 1059 pediatric patients, oxcarbazepine is safe and well tolerated in children ([lt]17 years of age) whether given as monotherapy or as adjunctive therapy.
[Supported by: Novartis]