Abstracts

RATIONALE: Levetiracetam is a new antiepileptic drug shown to be effective for the treatment of partial seizures in pivotal clinical trials. We prospectively followed up a consecutive group of patients with refractory epilepsy to investigate the efficacy and tolerability of levetiracetam, especially in those patients who would not be eligible for clinical trials due to factors such as mental retardation, psychiatric disorders or progressive neurological disease.
METHODS: Every patient with severe epilepsy irrespective of seizure type attending the investigators[ssquote] epilepsy clinic was offered levetiracetam as an add on treatment. 98 patients accepted to participate and were followed for one year. Demographic data, seizure frequency and side effects were recorded at baseline and during the first year follow-up. The first 35 patients were given levetiracetam at a starting dose of 500mg b.i.d. with weekly increments of 1000 mg (fast titration). The other patients were given levetiracetam with a starting dose of 250 mg b.i.d. with weekly increments of 250 mg (slow titration).
RESULTS: There were 47 females and 51 males with an average age of 39 years (SD14years). Seventy-nine had localization-related seizures. Twelve had symptomatic generalized seizures and seven had primary generalized seizures. The median number of seizures per month was seven and the median number of antiepileptic drugs was two. Twenty-two patients were mentally retarded (22%).
In the total population 14 patients were completely seizure free for at least the six last months, most from the first dose given. A total of 55 of the 98 patients were responders with [gt]50% seizure reduction by the end of the first year.
In the group with generalized seizures only one out of 19 became seizure free, but eight patients had a reduction of seizure frequency [gt]50%.
The average dose at the end of one year was 1900mg (SD900mg).
Thirty-seven patients discontinued levetiracetam (median 19 weeks of treatment). Seventeen discontinued due to adverse effects. In the group with fast titration 15 out of 35 (43%) experienced tiredness during the first 12 weeks and in the group with slower titration this was experienced by 20 out of 63 (32%). The difference was not statistically significant.
Behavioral adverse events, mainly irritability, were reported by five during the first 12 weeks of treatment and by seven after the first twelve weeks of treatment. This led to discontinuation of the drug in four of these patients. One patient discontinued the drug due to psychosis. Four of the patients who discontinued due to behavioral adverse events had previously had behavioral problems and/or mental retardation.
CONCLUSIONS: Levetiracetam appears to be well tolerated in this group of patients with severe epilepsy and shows efficacy even in a long-term follow-up. Behavioral adverse events were noted in a minority of patients and occurred mainly in patients who had a history of behavioral disturbance or were mentally retarded.
[Supported by: This study was funded by the Department of Neuroscience, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden]; (Disclosure: Grant - Elinor Ben-Menachem has a research grant from UCB, Consulting - Elinor Ben-Menachem has been a consultant for UCB)