Abstracts

Some newer antiepileptic drugs (AEDs) such as Levetiracetam (LEV) show a better tolerability and less interaction with concomitant medications than older AEDs. The aim of this study was to evaluate the efficacy and tolerability of LEV as add-on therapy or as substitutive monotherapy in adolescent and adult patients (pts) with refractory epilepsy (E) or with a poor tolerability of previous AEDs treatment., prospective, open-label, not controlled trial in which LEV was given as add on therapy or in substitution of previous monotherapy. LEV was started at 500 mg/day dose and progressively up titrated over 1[ndash]2 weeks by 500 mg/day every third day to a maximum dose of 2000[ndash]3000 mg/day. We report preliminary data about 30 pts (10 M and 20 F; mean age 42.47, sd= 19.69, min 17 max 86). Pts suffering from symptomatic encephalopathies, general diseases and history of psychiatric disorders and/or pseudo seizures, which could modify the seizure semiology and their frequency, were excluded. In 17 pts LEV was given as add on (group I) and 13 switched from previous AED to LEV monotherapy (group II). The mean follow-up was 88.15 days (SD=44.27, min.3, max 160).
Demographic and aetiological aspects were comparable in the 2 groups: mean age 41 (group I) vs 43 (group II); pts mainly affected by focal epilepsy in both groups with no cases of Lennox-Gastaut syndrome; mean seizure frequency at baseline was comparable in both groups.In group I we added LEV without modifying the previous AED therapy (number of AEDs: mean 2.18); in group II we switched previous AED to LEV. Therapy modification in group I was due to inefficacy in 9 pts, AEs in 3 pts and both in 5. In group II it was due to inefficacy in 7 pts, AEs in 3 pts and both in 3., [italic][underline]Efficacy[/underline][/italic]: in group I (LEV as add on therapy) 14/17 pts resulted evaluable (2 pts withdrew consent and 1 had a too short follow-up ([lt]30 days). At cut-off date (May 31^st 2006), 9 pts (64.3%) were seizure-free, 2 (14.3%) had a [gt]50% seizure frequency reduction and 3 (21.4%) were unchanged or worsened seizure frequency.
In group II (LEV as monotherapy) 11/13 pts resulted evaluable (1 pt withdrew consent and 1 had a too short follow-up ([lt] 30 days). At cut-off date, 7 pts (63.6%) were seizure-free, 3 (27.3%) showed a [gt]50% seizure frequency reduction and 1 (9.1%) remained unchanged.
Seizure type or aetiology did not appear correlated to the efficacy of LEV in pts with focal E.[italic][underline]Tolerability:[/underline][/italic] 7/30 pts (23.3%) reported AEs, which led to drug discontinuation in 2 cases. The most frequent AE resulted gastralgia (3 pts)., These preliminary results (the study foresees the enrollment of 80-100 pts and a follow up period of at least 12 months) suggest the good efficacy and tolerability of LEV in epileptic pts both as add-on therapy and as monotherapy. The study is currently ongoing and final data will be presented as soon as available.,