Abstracts

Levetiracetam[ssquote]s Efficacy in Adults and Children.

Abstract number : F.08
Submission category :
Year : 2001
Submission ID : 1185
Source : www.aesnet.org
Presentation date : 12/1/2001 12:00:00 AM
Published date : Dec 1, 2001, 06:00 AM

Authors :
C. Hovinga, Pharm.D., Neurology and Pharmacy, Cleveland Clinic Foundation, Cleveland, OH; H. Morris, M.D., Neurology, Cleveland Clinic Foundation, Cleveland, OH; K. Holland, M.D., Ph.D., Neurology, Cleveland Clinic Foundation, Cleveland, OH; N. Foldvary,

RATIONALE: Adult studies have shown that LEV reduces partial seizures. However, current literature fails to give data regarding LEV[ssquote]s efficacy in primary generalized seizures and there are no efficacy reports in children.
METHODS: For pts started on LEV after 1/00, records were reviewed retrospectively to obtain pt demographics, med. history, LEV dosing and tolerability. Seizure frequency before/after LEV was assessed. Percentage of pts with [gte]50% reduction in seizures (RR) and percentage becoming seizure free were determined.
RESULTS: 77 adult (median age 38, 19-72 yrs) and 27 pediatric (12, 2-18 yrs) pts had LEV added to a median of 2 AEDs in adults and 1 in children. 73% of adults and 56% of children had focal seizures. After 151[plusminus]87 days, median daily doses were 2000 mg (500-4000) in adults and 35 mg/kg (6.7-75) in children. Median seizure frequency decreased in adults (from 2 to 0.8 seizures/wk, 60%, p=0.039) and children (12.5 to 7 seizures/wk, 44%, NS). RR (adult 58%, pediatric 56%) and percentage of pts becoming seizure free (adult 25%, pediatric 22%) were similar. Among pts with focal seizures, median seizure frequency decreased in adults (from 1.9 to 0.3 seizures/wk, 84%, p=0.002) and in children (from 8.5 to 1.1 seizures/wk, 87%, p=0.03). For PGTC, median seizure frequency tended to increase in adults (from 0.5 to 0.75 seizures/wk, 50%, NS) and decrease in children (8 to 1.5 seizures/week, 81%, NS). Myoclonic seizures tended to increase in adults (from 2.4 to 3 seizures/wk, 25%, NS) and children (from 0 to 3 seizures/wk, NS). Dose reduction or removal of an AED was accomplished in adults (44%) and children (52%). 8 (10%) adults and 4 (15%) children were converted to monotherapy with 7 adults and 2 children becoming seizure free. Adverse events occurred in 56% and 52% of adult and children and resulted in LEV discontinuation in 14% and 11% of pts. LEV was discontinued in 13% and 26% of adult and children because of lack of efficacy. Common side effects in adults and children were somnolence (16, 11%), dizziness (12, 4%), depression (8, 11%), increased seizure frequency (12, 19%), and cognitive changes (5, 4%).
CONCLUSIONS: These results suggest LEV is effective in treating partial seizures and in some pts, LEV monotherapy can be effective. LEV had minimal efficacy in treating PGTC or myoclonic seizures. For other primary generalized seizures, the number of pts was too few for assessment. RR and percentage of seizure free pts were similar in both adults and children. Although a trend was observed in both groups, a significant reduction in total median seizures was only observed in adults. The lack of significance may reflect the larger variation in seizure frequency observed in the younger pts. Side effects were mild, reversible and tended to be CNS-related.