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Title: Keppra (Levetiracetam) Well-Tolerated, Effective For Seizures In Children Two Years Old

"Keppra (Levetiracetam) Well-Tolerated, Effective For Seizures In Children Two Years Old"

ST. PAUL, MN and SEATTLE, WA -- December 10, 2002 -- A retrospective review of clinical records by the Minnesota Epilepsy Group PAŽ found that the antiepileptic drug (AED) Keppra (levetiracetam), currently approved by the U.S. Food and Drug Administration for the adjunctive treatment of partial onset seizures in adults, may be considered as first-line anticonvulsant treatment in patients under two years of age. Results presented today at the American Epilepsy Society annual meeting showed that 12 of 20 pediatric patients had a greater than 50 percent reduction in seizures, including four patients who became seizure-free. An estimated 300,000 children in the United States under the age of 14 have epilepsy, according to the Epilepsy Foundation. For some children, epilepsy can be a temporary problem and easily controlled with medication, while for others, it may be a lifelong challenge affecting many areas of life. [1] "For physicians, it can sometimes be difficult to know which medications to consider for newborns and infants with epilepsy because most options have not yet been clinically tested in this age group," said Michael D. Frost, M.D., lead author of the study, pediatric neurologist at Minnesota Epilepsy Group PAŽ, and clinical assistant professor, Department of Neurology at the University of Minnesota. "Some of the children in this study were started on Keppra as their first AED. It appears to be safe, easy to administer and it improves seizure control." Study Design and Results In a review of records, researchers identified 22 patients (eight male and 14 female) between the ages of two days to 22 months (mean age 15 months) at the time they started Keppra therapy. Records were reviewed for starting dose, maximum dose, titration rate, tolerability and efficacy. Seizure type and epilepsy syndrome were also documented, with all patients having a history of either partial-onset or mixed seizures, including three with infantile spasms. Twenty patients were included in the final analysis, with two patients lost to follow up. Patients received Keppra in initial dosages of 10.4 mg/kg/day to 27.7 mg/kg/day (median 18.1 mg/kg), with maximum dosages of 15 mg/kg/day to 144 mg/kg/day (median 61.25 mg/kg) achieved after several days to six weeks Keppra was administered orally in either halved or quartered tablets as a solid dose, crushed and mixed with a spoonful of food such as applesauce or pudding, or dissolved in a small amount of water. Keppra was administered as monotherapy for six patients. Four patients received Keppra as their first AED and six patients received Keppra as their second AED. Of the 20 study patients on Keppra, 12 achieved a greater than 50 percent reduction in seizures. Additionally, six had a greater than 90 percent reduction in seizures and four patients were seizure-free. Side effects reported by caregivers of patients in the study were minimal and included a slight increase in hyperactivity or lethargy and fatigue Only one patient discontinued Keppra due to side effects. Side effects did not appear to be related to titration rate or maximum dose. Frost concluded, "Although a larger, controlled study would be of value, our results showed that Keppra is apparently safe, easily administered and maintained or improved seizure control in this age group." About Minnesota Epilepsy Group PAŽ Minnesota Epilepsy Group PAŽ specializes in evaluation, treatment, consultation and support services for adults, teens and children with seizure disorders. It is affiliated with United Hospital, an acute care facility that is one of the premier regional medical centers serving St. Paul and surrounding communities in Minnesota and western Wisconsin, and Children's Hospitals and Clinics - St. Paul, a specialty referral center that is part of Children's Hospitals and Clinics, the largest children's health care organization in the upper Midwest. More information is available by calling (651) 220-5290. Reference: [1] Epilepsy Foundation: Epilepsy in Children (Introduction). (http://www.efa.org/answerplace/children/into.html, accessed 11/20/02) SOURCE: Minnesota Epilepsy Group PAŽ

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