Abstracts

Pregabalin is a newly available antiepileptic drug (AED) that has been licensed in the U.S. as add-on therapy in adult patients with partial onset seizures. Studies evaluating the safety and efficacy of pregabalin in individuals less than 18 years of age are limited. This chart review explores the safety, tolerability and efficacy of pregabalin in pediatric patients with intractable epilepsy. Pregabalin is a [alpha][sub]2[/sub]-[delta] ligand that has anxiolytic, analgesic and anticonvulsant properties., This retrospective chart review study includes pediatric patients with intractable epilepsy treated with pregabalin. Safey and tolerability were assessed via patient and/or caregiver report of adverse events. Pregabalin[apos]s efficacy was evaluated via subjective patient and/or caregiver reports. In most cases, efficacy, safety and tolerability were assessed within 8 weeks after the initation of pregabalin therapy., Seventeen patients are included in the cohort. The patients range in age from 3 to 19 years, including 8 females and 9 males. Thirteen of 17 patients are diagnosed with localization related epilepsy; 3 of 17 patients are diagnosed with generalized epilepsy and 1 patient is diagnosed with mixed generalized and localization related epilepsy. Doses were initiated between 0.4 to 4 mg/kg/day and titrated up to maintenance doses ranging from 1.4 mg/kg/day to 8.7 mg/kg/day. Patients were treated with pregabalin for a period of 7 days to over 8 months. Three patients reported a side effect of somnolence. Other reported side effects include visual disturbance such as, [quot]unable to focus,[quot] moodiness and worsening balance. Of note, one adolescent patient intentionally overdosed on pregabalin and was hospitalized in an intensive care unit for 2 days. Pregabalin was discontinued in 3 patients due to an increase in seizure frequency., Seven out of 17 patients treated with pregabalin reported increased seizure frequency and/or intensity, and 1 out of 17 patients reported no improvement. However, one patient[apos]s caregiver reported an improvement in seizure control since starting pregabalin therapy. All 17 patients in the cohort received treatment from one or more AEDs. Four of the 7 patients with reported increased seizure frequency and/or intensity have localization related epilepsy, whereas 2 of the 7 patients have generalized epilepsy. Reports of increased seizure frequency and/or intensity appears unrelated to daily dose per kilogram. Further studies are necessary to determine the safety, tolerability and efficacy of pregabalin therapy in pediatric patients with intractable epilepsy.,