Abstracts

Rationale: Levetiracetam, a second-generation anti-epileptic drug (AED), has been found to be efficacious as adjunctive therapy in children with epilepsy. It is currently not approved as monotherapy in the United States, and thus significantly less attention has been devoted to its monotherapeutic use, especially in pediatric patients. The main objective of this study is to assess the efficacy, safety, and retention rates of levetiracetam monotherapy in children with epilepsy at two large tertiary epilepsy centers. Methods: We retrospectively reviewed a cohort of pediatric epilepsy patients receiving levetiracetam monotherapy as their antiepileptic drug regimen at Yale and Columbia Comprehensive Epilepsy Centers from January 2005 until January 2016. A detailed collection of demographic and clinical data, including age, gender, treatment regimens, efficacy, epilepsy types, six- and twelve-month retention rates, and side effects was performed. Results: One hundred and two patients (n=102) that received levetiracetam monotherapy at some point as their antiepileptic drug regimen were identified. Fifty-nine (57.8%) patients were male and forty-three (42.2%) patients were female with a mean age of 13.1 ± 4.6 years. The mean age at seizure onset was 10.1 ± 5.8 years of age.  Epilepsy types were focal in 47 subjects, idiopathic generalized in 42, symptomatic generalized in 7, and unclear in 6. Sixty patients were initially started on levetiracetam monotherapy while forty-two patients, who had attempted an average of 1.2 other AED(s) before, were converted to levetiracetam monotherapy due to intolerable side effects (24) or poor seizure control (18) on prior AEDs. Levetiracetam dosage ranged from 9.9 mg/kg to 75.3 mg/kg daily with a mean dosage of 26.7 ± 15.9 mg/kg. Duration of therapy ranged from 1 to 26 months with the median duration of 12.5 months. 6- and 12-month retention rate were 61.1% (47/77) and 53.1% (17/32), respectively. Twenty-two (22/47; 46.8%) subjects became seizure free on levetiracetam monotherapy for at least 6 months, while seven (7/17; 41.2%) reached 12-month seizure freedom. For the entire cohort, thirty-three (32.4%) patients reported side effects exclusively attributed to levetiracetam with irritability and moodiness (15.7%), depression (8.8%), and drowsiness (4.9%) being the most common. Overall, 27.5% of patients had behavioral adverse effects. In 19.6% of patients the adverse effects led to discontinuation of monotherapy. No patients experienced rash. Six (5.9%) subjects discontinued due to inefficacy.  Conclusions: Our results support the idea that levetiracetam monotherapy is a potentially effective antiepileptic drug regimen in pediatric patients with epilepsy. Patients commonly reported psychiatric and behavioral adverse effects. Therefore, larger, prospective studies are needed to determine predictors of these adverse effects and further validate the efficacy of levetiracetam monotherapy.   Funding: This research has not been funded by any sources and we did not receive any funding in support of this abstract.