Abstracts

RATIONALE: This is an analysis of the integrated summary of safety (ISS) report on levetiracetam (LEV) submitted for regulatory review.
METHODS: We obtained free access to the ISS for LEV to collate information about abnormal laboratory tests values and adverse event reports collected during the overall LEV development program. Analyses included 3347 patients exposed to LEV in clinical trials for epilepsy (N = 1422), cognition (N = 394) and anxiety disorders (N = 1084). Among these, there were many patients over the age of 65 (N = 263). This data is not available in previously published reports.
RESULTS: Safety data from all populations tested depict a similar pattern of adverse effects, predominantly somnolence, asthenia and dizziness that occurred most frequently during the first month of LEV treatment. Changes in laboratory test values from placebo-controlled trials that were statistically significant remained in the normal range (red blood cells, hematocrit, hemoglobin, white blood cells and neutrophils). COSTART preferred term infection (common cold, upper respiratory infection) was not preceded by low neutrophil counts that might suggest impaired immunological status. Higher incidences of adverse effects, particularly behavioral effects, were found among epilepsy patients than in elderly patients with cognitive disorders or patients with anxiety disorders.
CONCLUSIONS: This analysis of data from the integrated summary of safety suggests that LEV was safe for patients with seizure, cognitive and anxiety disorders. Review of the integrated summary of safety permits analyses (such as lab data evaluation) that cannot be done on individual clinical trials. Analyses of other populations (anxiety, cognitive disorders) permits inquiry into which adverse events may be specifically related to use of LEV in the epileptic brain.
Support: A grant from UCB Pharma.
Disclosure: Salary - Edrich -UCB Pharma. Grant - UCB Pharma. Honoraria - UCB Pharma.