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April 17, 2002

New Data Suggest Epilepsy Patients Stay on Treatment with Keppra

(Denver, CO and Philadelphia, PA) - The majority of patients taking the antiepileptic drug (AED) Keppra® (levetiracetam) stayed on therapy and relatively few patients reported behavioral side effects, according to a study presented today at the American Academy of Neurology annual meeting. Researchers at the University of Pennsylvania School of Medicine confirmed that the findings of this study support current labeling for Keppra.

Epilepsy is the most common neurological disorder of the brain, affecting nearly one percent of the world population-including more than 2.3 million Americans. Research has shown that up to 85 percent of people with epilepsy can gain full or partial control of their seizures with treatments such as AEDs.

"According to the data, patients can benefit from Keppra's efficacy and reduced risk of drug interactions without undue concern about behavioral side effects," said Jacqueline French, MD, associate professor in the Penn department of Neurology, associate director of the Penn Epilepsy Center, and an investigator in the study. "This large, multi-center, post-marketing analysis found the frequency of behavioral adverse events in patients on the drug to be in line with the product's current labeling.

"These results confirm that, similar to other AEDs, behavioral adverse events can occur with Keppra; however this usually does not lead to discontinuation of the drug," French added.

Results were based on data analysis from the Post-Marketing Antiepileptic Drug Survey
(PADS). PADS is a prospective registry provided by a consortium of 16 epilepsy centers to study patients treated with new AEDs. The survey records demographic data for each patient, as well as data on past behavioral and psychiatric disturbances and current or past antiepileptic drug use. PADS also contains data on seizure outcomes, adverse events and reasons for discontinuation.

Investigators studied PADS data for 288 patients starting Keppra therapy, with an average follow-up period of 240 days. Patients evaluated were between the ages of 8 months and 83 years and roughly half were men. The average Keppra dose in patients with behavioral adverse events was found to be 1,609 mg/day, compared to 1,792 mg/day in patients on Keppra who did not develop behavioral adverse events. Thirteen and half percent of patients or their designated caregivers reported behavioral problems while on Keppra, which caused 4.9 percent of them to stop taking the drug. In clinical trials, 13.3 percent of patients experienced behavioral symptoms.

Behavioral adverse events reported include irritability, aggression (in patients with mental retardation), depression, anxiety and mood swings. In patients who experienced behavioral events, 51.2 percent had a history of past psychiatric and behavioral problems or mental retardation, compared to 49.6 percent of the total Keppra group. There was no difference in Keppra titration between patients with behavioral adverse events as compared to the total Keppra group.

The Penn Epilepsy Center (PEC) provides the highest standard of care to patients with epilepsy and related problems. PEC offers state-of-the-art diagnostic techniques, medical treatments, surgery and support to patients with epilepsy.

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Editor's Note: Dr. French does not hold stock in UCB Pharma, Inc, although she has served as a consultant and lecturer. This project was conducted with support from UCB Pharma, Inc. One of Dr. French's co-authors on this study is an employee of the company.

The University of Pennsylvania Health System is distinguished not only by its historical significance - first hospital (1751), first medical school (1765), first university teaching hospital (1874), first fully integrated academic health system (1993) - but by its position as a major player on the world stage of medicine in the 21st century. Committed to a three-part mission of education, research, and clinical excellence, UPHS excels in all three areas.





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