Abstracts

RATIONALE: To evaluate the efficacy and tolerability of levetiracetam (LEV) add on therapy in elderly patients with refractory epilepsy (RE). Special populations such as the elderly are often not evaluated during the regulatory clinical trial program of new AEDs. However, the incidence and prevalence of epilepsy in this age category are increasing and their drug response may be different.
METHODS: Data of all patients with epilepsy exposed to LEV during the developmental program and older than 50 years were analyzed. Responder rates ([gte]50% and [gte]75% seizure reduction) and seizure freedom for the last 6 months and the last year were calculated. Tolerability was assessed by reporting of adverse events (AEs).
RESULTS: Data until a cut-off date June 30, 1999 (nearly the end of the development program in partial seizures) will be presented. There were 211 patients older than 50 ( including 14.7% older than 65) with RE which were exposed to LEV (median age 56 years, range 50-78 years). The median age of onset of epilepsy was 24.8 years (43.3 in patients older than 65). The median dose was 3000 mg/d. The mean duration of exposure was 697 days (range 1-2409 days). 43.6% of the patients were on 1 other AED and 42.7% on 2 AEDs.
At the end of the observation period 43.6% of the patients were still treated. In 19.9% the treatment was terminated because of adverse events, in 15.6% because of insufficient therapeutic effect, in 11.8% because of completion of the study and in the remaining patients due to different reasons including protocol violation.
The median seizure reduction from baseline was 43.9% (vs. 39.6% in the total population). The percentages of patients which had a seizure reduction of 50% or more or of 75% or more were comparable (37.2% vs 38.6% and 18.6% vs. 20.1%, respectively). Seizure freedom during the 6 months prior to the final evaluation and during the last year was more common in the elderly (19.0% vs 11.7 % and 15.2% vs 8.9%, respectively). In the subgroup of patients on only 1 concomitant AED 34.3% (vs 19.8) were seizure free during 6 months prior to the final evaluation.
AEs were mainly CNS related and mild. The incidences were comparable to the total population (n=1422) including somnolence (26.1% vs 23.0% in total population), asthenia (23.2% vs 22.6%) and dizziness (17.5% vs 18.9%). Other CNS-related AEs expected to be higher in an elderly population such as confusion (5.7% vs 3.9%), hostility (1.4% vs 3.9%), emotional lability (3.3% vs 3.8%) and insomnia (8.5% vs 7.4%) were not very different from the total population. There was no evidence for idiosyncratic side effects.
CONCLUSIONS: LEV shows higher seizure freedom rates and similar tolerability in patients older than 50 years, compared to the total population studied.
Support: UCB Pharma, Brussels, Belgium.
Disclosure: Salary - UCB (Pascal Edrich is an employee of UCB); Consulting - UCB (Guenter Kraemer) Honoraria - UCB (Guenter Kraemer)