Behavioral Changes Associated with Levetiracetam Use in Patients with Epilepsy
Abstract number :
J.08
Submission category :
Year :
2001
Submission ID :
905
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
J.J. Asconapé, MD, Neurology, Indiana University, Indianapolis, IN; J.M. Gerardot, RN, Neurology, Indiana University, Indianapolis, IN; G. Da Costa, MD, Neurology, Indiana University, Indianapolis, IN
RATIONALE: Behavioral disturbances were observed in approximately 2% of patients treated with levetiracetam (LVT) during pre-marketing clinical trials, whereas, post-marketing anecdotal reports suggest a higher incidence. We reviewed our experience with the behavioral manifestations of LVT use for the treatment of epilepsy.
METHODS: Medical records of patients treated with LVT at Indiana University were reviewed. All patients were specifically interrogated about behavioral changes either during their office visits or by phone contacts.
RESULTS: The population consisted of 101 patients with a mean age of 31.7 years (r: 7-52 years), a mean dose of LVT of 2232.5 mg/d, and a mean duration of therapy of 6.5 months. Behavioral changes were reported by 31 (30.7%) patients. They were mild in 17 (16.8%) patients, moderate in 7 (6.9%), and severe in 7 (6.9%). The mild cases were of little clinical significance and required no specific intervention. All severe cases required discontinuation of therapy.
Most common symptoms reported were: irritability 23 (22.8%) patients, aggressiveness 10 (9.9%), emotional lability 9 (8.9%), hostility 7 (6.9%), hallucinations 5 (4.9%), depression 4 (3.9%), anxiety 4 (3.9%), insomnia 3 (2.9%). The combination of irritability and emotional lability was common (8.9%). One patient developed psychosis with paranoid ideation.
A history of behavioral disturbance was found in 19 (61.3%) of the patients with behavioral symptoms during LVT therapy, and in 31 (44.3%) of the patients without. Mental retardation was observed in 9 (29%) of the patients with and in 11 (15.7%) of the patients without behavioral symptoms. The mean daily dose of LVT in patients with and without behavioral changes was 2383 mg and 2167 mg respectively.
CONCLUSIONS: The incidence of behavioral disturbances with the use of LVT appears to be higher than what has been reported in pre-marketing trials. The higher incidence in this series is in part explained by the methodology used in collecting the information. In approximately 14% of the patients the behavioral changes were moderate to severe and an important tolerability issue. A history of behavioral disturbance and mental retardation appear to be risk factors. Caution with the use of LVT in these populations is recommended.
Disclosure: Honoraria - Given occasional talks on levetiracetam for which I received an honorarium from the manufacturer