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RESEARCH PRODUCT

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

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Abstract 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 1000–3000mgperday. 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.