The safety and efficacy of add-on levetiracetam in elderly patients with focal epilepsy: a one-year observational study.

摘要

PURPOSE: The long-term safety and efficacy of levetiracetam (LEV) was evaluated as add-on therapy in focal epilepsy patients (n=491) aged at least 65 years who failed at least one monotherapy. METHODS: Patients (n=491) with focal epilepsy treated with at least one antiepileptic drug in monotherapy with insufficient seizure control were included in this prospective open-label study. The recommended LEV dose range was 1000-3000 mg per day. Follow-up visits were done approximately after 3, 6 and 12 months. Safety and efficacy was analysed based on all patients who received LEV (safety population, n=491) and all patients who were seen at all visits and completed the trial (per protocol population, n=364). RESULTS: Patients (53% men, median age 71 years) had a total of 97 adverse events (AEs) reported in 53 patients. The most common AEs were fatigue and restlessness (9.7% each of all AEs). A total of 35 serious AEs occurred in 19 patients (3.9% of the safety population), all but one unrelated to the study medication. Mean monthly seizure frequency dropped significantly from 7.0 (SD 8.7, range 1-85, median 4) at baseline to 1.7 (SD 2.9, range 0-29, median 1) at 3 month, 1.2 (SD 2.6, range 0-30, median 0) at 6, and 1.4 (SD 6.6, range 0-99, median 0) at 12 months, corresponding to a reduction of 75.7%, 82.9%, and 80.0% relative to baseline. Seizure freedom was reported by 42%, 57.7%, and 58% of patients during the previous period at 3, 6 and 12 months follow-up, respectively. CONCLUSIONS: Add-on treatment with LEV in elderly patients with focal epilepsy was safe and efficient. Levetiracetam might be considered as a suitable drug in the elderly.