Yi Wang1, Yin-Bo Chen2, Yu-Qin Zhang3, Rong Luo4, Hua Wang5, Jun-Lan Lv6, Dong Wang7, Sui-Qiang Zhu8, Zhong-Dong Lin9, Jiong Qin10,11. 1. Department of Neurology, Children's Hospital of Fudan University, Shanghai, China. 2. Department of Pediatric Neurology, The First Bethune Hospital of Jilin University, Changchun, China. 3. Department of Neurology, Tianjin Children's Hospital, Tianjin, China. 4. Department of Pediatric Neurology, West China Second University Hospital of Sichuan University, Chengdu, China. 5. Department of Pediatric Neurology, Shengjing Hospital of China Medical University, Shenyang, China. 6. Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China. 7. Department of Neurology, Xi'an Children's Hospital, Xi'an, China. 8. Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China. 9. Department of Pediatric Neurology, The 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. 10. Department of Pediatrics, Peking University People's Hospital, No.11 Xizhimen South Str., Xicheng District, Beijing, 100044, China. jiongqinbeijing01@126.com. 11. Department of Pediatrics, Peking University First Hospital, Beijing, China. jiongqinbeijing01@126.com.
Abstract
BACKGROUND: To assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-16 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. METHODS: This 26-week, single arm, multicenter and observational study recruited patients aged 2-16 years with PS or GTCS suitable for OXC oral suspension treatment. Enrolled patients received OXC oral suspension treatment for 26 weeks. Primary endpoints included mean seizure frequency at the end of the treatment and mean seizure frequency reduction at the end of the treatment vs. baseline. Secondary efficacy-related endpoints and safety parameters were also assessed. RESULTS: Nine hundred and eighty-seven pediatric patients were enrolled and 912 (92.4%) completed the study. The mean seizure frequencies at baseline and the end of week 26 were 13.40±64.92 and 1.62±19.47 times/ month, respectively. The mean seizure frequency reduction was 10.03±63.67 times/month and the mean seizure frequency reduction percentage was 90.02%±5127.0% (P<0.0001). After 26 weeks of treatment, 82.36%, 7.24% and 3.86% of the patients became controlled, significantly improved and improved, respectively. Adverse events (AEs) were reported in 74 (7.65%) patients. Rash was the most common AE. The efficacy of OXC was not affected by seizure types, age or gender. CONCLUSIONS: This study confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-16 years with PS and/or GTCS.
BACKGROUND: To assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-16 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. METHODS: This 26-week, single arm, multicenter and observational study recruited patients aged 2-16 years with PS or GTCS suitable for OXC oral suspension treatment. Enrolled patients received OXC oral suspension treatment for 26 weeks. Primary endpoints included mean seizure frequency at the end of the treatment and mean seizure frequency reduction at the end of the treatment vs. baseline. Secondary efficacy-related endpoints and safety parameters were also assessed. RESULTS: Nine hundred and eighty-seven pediatric patients were enrolled and 912 (92.4%) completed the study. The mean seizure frequencies at baseline and the end of week 26 were 13.40±64.92 and 1.62±19.47 times/ month, respectively. The mean seizure frequency reduction was 10.03±63.67 times/month and the mean seizure frequency reduction percentage was 90.02%±5127.0% (P<0.0001). After 26 weeks of treatment, 82.36%, 7.24% and 3.86% of the patients became controlled, significantly improved and improved, respectively. Adverse events (AEs) were reported in 74 (7.65%) patients. Rash was the most common AE. The efficacy of OXC was not affected by seizure types, age or gender. CONCLUSIONS: This study confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-16 years with PS and/or GTCS.
Authors: E Franzoni; C Garone; J Sarajlija; S Gualandi; E Malaspina; I Cecconi; F C Moscano; V Marchiani Journal: Seizure Date: 2006-03-22 Impact factor: 3.184