The aim of this study is to evaluate the prevalence and risk factors of seizure aggravation of adjunctive levetiracetam therapy in children with epilepsy. Methods: We retrospectively identified 125 children (0.3-18 years) with epilepsy who were newly treated with adjunctive levetiracetam therapy from November 2008 to July 2014 in Pusan National University Hospital, and 44 patients were excluded according to the exclusion criteria. Aggravation was diagnosed if the seizure frequency increased by more than 50% of baseline or there were new types of seizures after 1 month of adjunctive levetiracetam therapy. Results: Eighty-one patients (male:female, 44:37) were enrolled, including 27 (33.5%) with generalized seizures and 54 (66.7%) with focal seizures. Twelve patients (14.8%) exhibited seizure aggravation and 69 patients (85.2%) had improvement or no change after 1 month of levetiracetam therapy. Eleven patients (91.7%) in seizure aggravation group and 16 patients (23.2%) in non-seizure aggravation group had generalized seizures, with aggravation significantly more frequent in patients with generalized seizures (P < 0.001). Other factors such as age at diagnosis, age at adding levetiracetam, sex, baseline seizure frequency, etiology, electroencephalography and magnetic resonance imaging abnormalities, and concomitant drug use were not identified as risk factors. Conclusion: Although levetiracetam is an effective antiepileptic drug in children with epilepsy, adjunctive levetiracetam therapy was associated with worsening of seizures in 14.8 % of included patients, especially those with generalized seizures. Careful monitoring for increased seizure frequency or the onset of a new type of seizures is advised for patients prescribed levetiracetam add-on treatment.
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