(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.
# # #
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.
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