Abstracts

Clinical practice differ significantly from the methodology used in postmarketing studies to assess the efficacy and tolerability of antiepileptic medications. Retrospective review permits analysis of the practice parameters and outcome measures without influencing them. The lack of restrictions regarding label indications, titration parameters, dosage, etc may change the outcome compared to controlled prospective studies. To compare the experience of a typical epilepsy center and the postmarketing data regarding the outcome after treatment of epilepsy with levetiracetam, restropective review were performed at the Epilepsy Clinic at The UF Neuroscience Institute, Jacksonville, FL between July 1,2002 and June 30, 2004. 100 random charts containing patients treated with Levetiracetam were extracted from our epilepsy clinic database. Incomplete records were excluded. 68 patients with diagnosis of epilepsy treated with levetiracetam were included. 68 patients included 53% women and 47% men, 19% had a generalized epileptic disorder and 81% had focal epilepsy with or without generalization. The average age was 45 years including three (4.4%) children. The average total dose was 1994 mg and 17.6% was monotherapy. The overall seizure reduction at least 50% of reported baseline was 57% including a seizure free of 36%. Among the patients on monotherapy 50% became seizure free and 75% had a seizure reduction at least of 50%. The side effects more commonly reported included somnolence 17.6% and behavioral 11.8%. Memory deficit and dizziness occurred only in 2.9 and 1.5% respectively. 17% discontinued treatment because of side effects and it was related to behavioral side effects (7.4%) and sedation (7.3%). Only 4.4% discontinued treatment due to lack of efficacy.
Comparing with the results of the Keeper trial efficacy was similar, at least 50% seizure reduction of 57% in both studies and a seizure free of 36% versus 20% in Keeper trial.The side effect profile was similar as well regarding somnolence 17% versus 16% and behavioral 11.8% versus 7.4%. However dizziness was rather infrequent 2.9% compared with 9.0% in the Keeper trial. . The results of this study are comparable with the Keeper trial, a multicenter open label community based study, including efficacy and side effect profile. This study included small group of patients on monotherapy who reported higher seizure freedom and efficacy, however the number is too small to draw conclusions.[table1] (Supported by unrestricted grant by UCB.)