Abstracts

RATIONALE: Limited published data is available regarding levetiracetam (Keppra[reg]) use in pediatric patients and no published data is available in this population for seizure types other than partial onset, use as monotherapy or at doses higher than 20 mg/kg/day. The objective of the present evaluation was to examine retrospectively, the outcome of levetiracetam (LEV) treatment in a group of pediatric patients many of whom have failed one or more previous antiepileptic drug (AED) regimens. LEV presents advantages for the pediatric population which include rapid onset, linear kinetics, lack of liver metabolism, lack of drug-drug interactions, lack of protein binding ([lt]10% bound) and lack of reactive metabolites. LEV has not been shown to cause weight gain, alopecia or increased incidence of rash.
METHODS: We reviewed data from 55 patients (age range 7 months to 31 years, weight range 9.5 - 77 kg). Most patients experienced multiple seizure types, which included generalized tonic-clonic n = 22, complex partial n = 23, absence n = 12, myoclonic/Juvenile Myoclonic Epilepsy n = 5, tonic n = 2, Lennox Gastaut Syndrome n = 1, atonic n = 1, frontal lobe n = 1, and benign focal epilepsy of childhood n = 1. Efficacy was evaluated on a scale of poor response to excellent response. Safety reports were collected. Descriptive statistics were performed.
RESULTS: The analysis included male and female children, who had a history of AED use (none n = 5; 1 n = 15; 2 or more n = 35) and LEV exposure [dose: range = 375 - 6000 mg/day (7.7 - 314.5 mg/kg/day)] either as monotherapy n = 20 (36.4%) or adjunctive therapy [1 n = 17 (30.9%); 2 or more n = 18 (32.7%)]. LEV therapy resulted in an excellent response n = 11 (20.0%), good response n = 7 (12.7%), some improvement n = 7 (12.7%), poor response n = 27 (49.1%) and uncertain effect n = 3 (5.5%). Patient or care giver reports regarding safety included no adverse effects n = 32 (58.2%), aggression n = 8, sedation n = 3, irritability n = 3, paresthesia n = 1, ataxia n = 1, depression n = 1, rash n = 1, diarrhea n = 1, acne n = 1, tremor n = 1, nausea n = 1, sexual self stimulation n = 1.
CONCLUSIONS: We conclude that treatment with LEV was associated with outcome improvement in 45.5% of pediatric patients, most with multiple seizure types. Safety reporting was as predicted by well-controlled adult studies. LEV would appear to be a favorable treatment for pediatric patients.