PMID- 29464579 OWN - NLM STAT- MEDLINE DCOM- 20181114 LR - 20181202 IS - 1867-0687 (Electronic) VI - 14 IP - 3 DP - 2018 Jun TI - Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic-clonic seizures in routine clinical practice in China: a prospective observational study. PG - 280-289 LID - 10.1007/s12519-017-0114-6 [doi] AB - BACKGROUND: This study aimed to assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-5 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. METHODS: This 26-week, prospective, single-arm, multicenter, observational study recruited pediatric patients aged 2-5 years with PS or GTCS suitable for OXC oral suspension treatment based on physicians' judgments from 11 medical centers in China. Enrolled subjects started OXC oral suspension treatment as monotherapy or in combination with other antiepileptic drugs. Primary efficacy outcome was the percentage of pediatric subjects achieving >/= 50% seizure frequency reduction at the end of the 26-week treatment. Secondary efficacy-related parameters and safety parameters such as adverse events (AEs) and serious AEs (SAEs) were also monitored during the 26-week treatment period. RESULTS: Six hundred and six pediatric patients were enrolled and 531 (87.6%) completed the study. After 26 weeks of treatment, 93.3% subjects achieved >/= 50% seizure frequency reduction, and 81.8% achieved 100% seizure frequency reduction compared to baseline. Among different seizure types, OXC was effective in all subjects with simple PS and in > 90% of subject with other type of seizure present in the study. AEs were observed in 49 (8.1%) subjects. Only three subjects experienced SAE. Rash (n = 18, 2.97%) was the most common AE. Only 17 subjects discontinued due to AEs. CONCLUSION: This study, reporting the real-world data, further confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-5 years with PS and/or GTCS. FAU - Qin, Jiong AU - Qin J AD - Department of Pediatrics, Peking University People's Hospital, No. 11 Xi Zhi Men Nan Da Jie, Xicheng District, Beijing, 100044, China. jiongqinbeijing01@126.com. AD - Department of Pediatrics, Peking University First Hospital, Beijing, China. jiongqinbeijing01@126.com. FAU - Wang, Yi AU - Wang Y AD - Department of Neurology, Children's Hospital, Fudan University, Shanghai, China. FAU - Huang, Xin-Fang AU - Huang XF AD - Department of Pediatrics, Quanzhou Women's and Children's Hospital, Quanzhou, China. FAU - Zhang, Yu-Qin AU - Zhang YQ AD - Department of Neurology, Tianjin Children's Hospital, Tianjin, China. FAU - Fang, Fang AU - Fang F AD - Department of Neurology, Beijing Children's Hospital, Beijing, China. FAU - Chen, Yin-Bo AU - Chen YB AD - Department of Pediatric Neurology, The First Bethune Hospital, Jilin University, Changchun, China. FAU - Lin, Zhong-Dong AU - Lin ZD AD - Department of Pediatric Neurology, The 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China. FAU - Deng, Yan-Chun AU - Deng YC AD - Department of Neurology, Xijing Hospital, Xi'an, China. FAU - Yin, Fei AU - Yin F AD - Department of Pediatrics, Xiangya Hospital, Central South University, Changsha, China. FAU - Jiang, Li AU - Jiang L AD - Department of Neurology, Children's Hospital, Chongqing Medical University, Chongqing, China. FAU - Wu, Ye AU - Wu Y AD - Department of Pediatrics, Peking University First Hospital, Beijing, China. FAU - Hu, Xiang-Shu AU - Hu XS AD - The third Department of Neurology, Guangdong 999 Brain Hospital, Guangzhou, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20180220 PL - Switzerland TA - World J Pediatr JT - World journal of pediatrics : WJP JID - 101278599 RN - 0 (Anticonvulsants) RN - 33CM23913M (Carbamazepine) RN - VZI5B1W380 (Oxcarbazepine) SB - IM MH - Administration, Oral MH - Age Factors MH - Anticonvulsants/adverse effects/*therapeutic use MH - Carbamazepine/adverse effects/*analogs & derivatives/therapeutic use MH - Child, Preschool MH - China MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Epilepsy, Tonic-Clonic/diagnosis/*drug therapy MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Oxcarbazepine MH - Prospective Studies MH - Seizures/diagnosis/*drug therapy MH - Severity of Illness Index MH - Treatment Outcome OTO - NOTNLM OT - Antiepileptic drugs OT - Generalized tonic-clonic seizures OT - Oxcarbazepine oral suspension OT - Partial seizures OT - Pediatric patients EDAT- 2018/02/22 06:00 MHDA- 2018/11/15 06:00 CRDT- 2018/02/22 06:00 PHST- 2016/11/09 00:00 [received] PHST- 2017/04/17 00:00 [accepted] PHST- 2018/02/22 06:00 [pubmed] PHST- 2018/11/15 06:00 [medline] PHST- 2018/02/22 06:00 [entrez] AID - 10.1007/s12519-017-0114-6 [pii] AID - 10.1007/s12519-017-0114-6 [doi] PST - ppublish SO - World J Pediatr. 2018 Jun;14(3):280-289. doi: 10.1007/s12519-017-0114-6. Epub 2018 Feb 20.