Abstracts

To evaluate the short- and long-term safety of rufinamide in pediatric patients with epilepsy.,
Safety data were derived from all of the short-term, double-blind, placebo-controlled studies and long-term, open-label studies of adjunctive rufinamide therapy in pediatric patients with inadequately controlled seizures. Databases from the different trials were integrated into a single database including 212 rufinamide-treated patients and 197 placebo-treated patients for short-term double-blind trials and 391 patients for long-term trials. All patients who received [ge]1 dose of study drug were included in the analysis. Adverse events (AEs) were analyzed using the Medical Dictionary for Regulatory Activities and were presented by preferred term. Clinical laboratory tests, serious adverse events (SAEs), and AEs leading to study discontinuation were also evaluated.,
In short-term, double-blind trials, the median age was 11 years and the median weight was 35 kg; median duration of exposure was 3.0 months and median daily dose of rufinamide was 41.96 mg/kg per day. The most commonly reported Aes for rufinamide versus placebo patients included somnolence (17.0% vs 8.1%), vomiting (16.5% vs 7.1%), headache (16.0% vs 8.1%), and pyrexia (11.3% vs 10.7%). Most Aes were mild to moderate in severity. A higher percentage of patients in the rufinamide group (7.1%) compared to the placebo group (2.0%) discontinued treatment due to Aes. Serious adverse events were reported in 7.5% of rufinamide-treated patients and 5.6% of placebo-treated patients. Serious adverse events led to study discontinuation of 3.3% of rufinamide-treated patients and 1.0% of placebo-treated patients. In long-term therapy (N=391), the median daily dose of rufinamide administered was 41.67 mg/kg per day and the median duration of rufinamide exposure was 14.5 months; 54% of patients were given the drug for [ge]12 months. The most commonly reported AEs during long-term therapy were vomiting (26.3%), headache (22.3%), pyrexia (18.7%), somnolence (18.7%), and upper respiratory tract infection (17.9%); 86 patients (22.0%) experienced [ge]1 severe AE. Adverse events led to the study discontinuation of 12.5% of patients; no single AE led to study discontinuation of [gt]2.0% of patients. Serious adverse events were reported in 15.6% of patients; 4.9% of patients discontinued treatment due to SAEs.,
Short- and long-term rufinamide therapy were generally well tolerated in pediatric patients with epilepsy.,