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Title: Behavior Improvement Noted in Epileptic Children Treated With Keppra (Levetiracetam): Presented at AESM

"Behavior Improvement Noted in Epileptic Children Treated With Keppra (Levetiracetam): Presented at AESM"

Additional Study Presented at American Epilepsy Society Meeting Shows Low Incidence of Keppra-Related Behavioral Side Effects in Adults ST. PAUL, MN and SEATTLE, WA -- December 10, 2002 -- Two separate studies presented at the American Epilepsy Society annual meeting by researchers from the Minnesota Epilepsy Group PAŽ examined the antiepileptic drug Keppra (levetiracetam) and its effect on behavior in children and adults with epilepsy. One study found that Keppra improved behavior in some children with epilepsy who have a history of underlying behavioral problems, and the other study of adults with epilepsy found that clinically significant behavioral consequences of Keppra were eight percent, indicating that frequency of these events appears to be no higher, and in fact may be lower, than reported for other new antiepileptic drugs (AEDs). An estimated 2.3 million Americans have epilepsy, [1] and worldwide the disorder is more common than Alzheimer's disease. [2] Approximately 300,000 American children under the age of 14 years have epilepsy, [3] with one-third of new epilepsy cases beginning during childhood. [4] "We conducted these studies to attempt to evaluate the validity of the perception within the epileptology community that patients taking Keppra have an increased number of behavioral adverse events compared to other new antiepileptic drugs," said John Gates, M.D., lead investigator of the adult study, neurologist at Minnesota Epilepsy Group PAŽ and clinical professor of neurology at the University of Minnesota. "Our two studies do not support this perception. The efficacy of Keppra in treating seizures, coupled with our findings of its low side effect profile, makes it an option that should be considered, especially for those who have struggled with other treatments." Both studies evaluated patients with epilepsy proven resistant to other medications, and who were referred to a tertiary epilepsy care center. Pediatric Study Findings The pediatric study was designed to evaluate the impact of Keppra on children's behavior, and results showed that nearly a third of the patients studied reported improvements in behavior once they began therapy with Keppra. "These findings were intriguing and should lead to a follow-up study to determine exactly why this group of patients experienced an improvement in behavioral problems with Keppra," said Mary Gustafson, Pharm.D, lead investigator of the study and epilepsy clinical pharmacist at Minnesota Epilepsy Group PAŽ. The study evaluated medical records of 115 children between one and 11 years old treated with Keppra for epilepsy resistant to treatment. Records were reviewed for demographics, history of underlying behavioral problems and previous medications causing behavioral or emotional problems, and changes in behavior or emotional status following treatment with Keppra There were 63 children with a documented history of underlying behavioral or emotional problems innate to each child. Sixty-five percent of this group experienced a worsening of their underlying behavioral/emotional problems with at least one previously prescribed AED. After initiating treatment with Keppra, parents reported that 32 percent (n=20) of these patients reported improvements in behavior, 40 percent (n=25) had no change and 29 percent (n=18) had a worsening of behavioral problems. Of the 52 children with no history of underlying behavioral or emotional problems, 80.8 percent (n=42) were unchanged, 9.6 percent (n=5) were reported as doing better, and the same number developed behavioral or emotional problems. The most common problems reported by both groups were aggressiveness (n=20) and oppositional behaviors (n=16) as well as emotional lability. Adult Study Findings The adult study identified 61 patients with epilepsy between 17 and 76 years old, and results found that when treated with Keppra, they experienced a lower incidence of behavioral side effects than that reported for other new AEDs. The study utilized doses of Keppra between 500 and 3,000 mg/day. Of all patients, five (or eight percent of those studied) experienced behavioral side effects. "The eight percent incidence of behavioral adverse events with Keppra appears to be lower than what has been reported for other new AEDs," said Gates. "Obviously, physicians, patients and caregivers tend to remember when medications cause side effects, which could explain why higher rates are sometimes perceived than what is shown in controlled studies." The adult study retrospectively reviewed patients from the clinic database identified as having medically intractable epilepsy who had Keppra introduced as add-on therapy for at least six months. Patients with histories of resistant epilepsy were reviewed for evidence of behavioral side effects, defined as any significant behavioral or mood change requiring medical, psychological or community intervention. Of the 61 patients, five developed behavioral side effects. Once Keppra was discontinued, all had symptom resolution. "Our findings reaffirm that physicians should feel comfortable prescribing Keppra because of its efficacy and low incidence of behavioral side effects," said Gates. 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. References: [1] http://www.efa.org/epusa/nation/nation.html#3 (accessed 11/21/02) [2] http://www.who.int/whr/2001/main/en/media/disorders.htm (accessed 11/21/02) [3] http://www.efa.org/answerplace/children/intro.html (accessed 11/19/02) [4] "Notice to Readers: National Epilepsy Month, November 2002," Morbidity and Mortality Weekly Report. November 8, 2002 / 51(44);1000. SOURCE: Minnesota Epilepsy Group PAŽ

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