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World Journal of Pediatrics
Published in: World Journal of Pediatrics 3/2018

01-06-2018 | Original Article

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

Authors: Jiong Qin, Yi Wang, Xin-Fang Huang, Yu-Qin Zhang, Fang Fang, Yin-Bo Chen, Zhong-Dong Lin, Yan-Chun Deng, Fei Yin, Li Jiang, Ye Wu, Xiang-Shu Hu

Published in: World Journal of Pediatrics | Issue 3/2018

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Abstract

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.
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Metadata
Title
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
Authors
Jiong Qin
Yi Wang
Xin-Fang Huang
Yu-Qin Zhang
Fang Fang
Yin-Bo Chen
Zhong-Dong Lin
Yan-Chun Deng
Fei Yin
Li Jiang
Ye Wu
Xiang-Shu Hu
Publication date
01-06-2018
Publisher
Childrens Hospital, Zhejiang University School of Medicine
Published in
World Journal of Pediatrics / Issue 3/2018
Print ISSN: 1708-8569
Electronic ISSN: 1867-0687
DOI
https://doi.org/10.1007/s12519-017-0114-6

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