부적절하게 조절되는 소아 간질 환자에서 Topiramate의 병용투여 효과:개방성 Phase IV 다기관 연구.

초록

PURPOSE: To evaluate the efficacy and safety of topiramate up to 9mg/kg/day in children as adjunctive therapy for inadequately controlled partial seizures with or without secondary generalization and Lennox-Gastaut syndrome. METHODS: This study was a prospective, multicenter, add-on, and open-label study. Patients between age 2 to 16 years with previous 4 weeks seizure record were treated with topiramate for 24 weeks. Study design consisted of a 4 weeks baseline phase, a 12 weeks of titration phase, and a 12 weeks stabilization period. Efficacy was primarily assessed by measuring median seizure frequency reduction rate and other efficacy variables included responder rate, seizure free rate, and global evaluation by investigators and parents. Treatment emergent adverse events were also investigated. RESULTS: Among 192 patients screened, 184 patients were included for efficacy measurement by intention-to-treat analysis. Median seizure frequency reduction rate were 62.2% during the entire period and 67.1% during the stabilization period. Responder rate were 59.2% during the entire period and 60.9% during the stabilization period. Seizure free rate were 6.5% during the entire period and 16.3% during the stabilization period. The incidence of treatment emergent adverse events was 44% with anorexia and somnolence being the most frequent. 64.3% of patients with adverse events reported resolution of adverse effects during the trial. CONCLUSION: Results in this cohort of 184 patients with refractory seizures show topiramate to be highly effective and safe as add-on therapy in medically refractory partial seizures and Lennox-Gastaut syndrome in pediatric population.

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