Abstracts

RATIONALE: Levetiracetam (LEV)is approved for treatment of partial onset seizures in adults with epilepsy. Adverse effects (AE[ssquote]s)include: somnolence (15%),behavioral disturbance(14%),and infection (13%). These are major concerns in treating special populations. This study evaluates the efficacy of LEV and its AE[ssquote]s in developmentally delayed/mentally retarded (MR)adults (IQ 50)[lte]with seizures.The objective was to see if special precautions are needed in the use of LEV in this vulnerable population.
METHODS: This is a retrospective chart review of 28 adults. Data was routinely charted regarding behavioral disturbances, somnolence, infection, and seizures. LEV was used in polytherapy. Each patient had at least one comprehensive behavioral assessment. More than half had a slower dosing regimen of LEV than usual. Patients were analyzed in groups (per seizure syndrome or predominant brain pathology)as regards to behavioral scores,new behavior disturbance, seizure frequency, and daytime alertness.Infection rate and complete blood count compared to pretreatment were reviewed.Many patients had LEV levels.
RESULTS: The Lennox Gastaut group (6 patients)showed the most seizure reduction. A few patients became seizure free (one with Angelman[ssquote]s syndrome and one with cortical dysplasia)but there were no group trends. Patients with tuberous sclerosis, Rett syndrome, post-viral encephalopathy,Down[ssquote]s syndrome, and birth anoxia showed minimal to no improvement. No status epilepticus or seizure exacerbation occurred.Daytime napping did not increase. Lack of participation in day programs due to somnolence was seen to decrease in several patients. One patient became somnolent on LEV 500 mg/day but on retrial with fewer neuroleptics,was not sleepy.
One third showed behavioral improvement, while one patient was withdrawn for tearfulness and anxiety (1000 mg LEV). No other new behavioral disturbances were noted.
Levels varied between 15.9 and 35. Serum level and efficacy did not correlate. Leukopenia, neutropenia,and infections did not increase.
CONCLUSIONS: The effect of adjunctive LEV was evaluated in 28 adults with MR and refractory epilepsy.Improvement or no change in seizures was seen. No exacerbation of seizures was noted due to LEV. Behavioral improvement was seen in individuals in all groups, which may reflect withdrawal of other drugs. Somnolence was less than expected and most patients were titrated slowly. No changes were seen in infection rate or CBC but may not be reflected in this small sample. Infection, somnolence and behavioral disturbance may impact quality of life in this population as much as seizures.These do not appear to be more prominent in this population when treated with LEV.
Support: not supported
Disclosure: Consulting - Elan, Parke-Davis, Novartis,Glaxo,Ortho-McNeill, Carter-Wallace, UCB-Pharma Honoraria - Although not financially significant, I have received honoraria for speaking from speakers bureaus associated with Novartis, UCB-Pharma, Ortho-McNeill, Glaxo, Parke-Davis, Carter-Wallace,(and prior to 1996 from Abbott).