To assess the effect and tolerability of zonisamide (ZNS) as adjunctive treatment for difficult-to-treat epilepsy in adult Scandinavian patients.Material and methods
151 outpatients (mean age: 42.5 years) from 18 centres in Denmark, Sweden and Norway were recruited to the study. 81.5% had focal epilepsy, and the mean number of previously tried AEDs was 4.5. The patients were given ZNS as add-on treatment, and the ZNS dosing and the visit frequency were governed by the treating physician. The primary efficacy endpoint was the retention rate after 12-month treatment. Assessments included also responder rate, type and frequency of adverse events, healthcare resource utilization (HCRU) and quality of life (QOLIE-31).Results
90 patients (59.6%) completed the study. Mean daily ZNS dose was 300.8 mg. After 12 months, 81 patients were still on ZNS, that is a retention rate of 53.6%. The mean reduction of seizure frequency at 12 months was 27%. Best effect was seen in those with focal and those with secondary generalized seizures. In the QOLIE-31, there was a mean increase from baseline of 4.8 points. The tolerability was generally good. The majority of side effects were CNS-related, dizziness, fatigue, seizure aggravation, and headache being most prevalent. 21.2% had adverse events leading to withdrawal of ZNS.Conclusions
A retention rate of 53.6% after 1 year of treatment with ZNS is roughly in accordance with the retention rates found for lamotrigine, oxcarbazepine, levetiracetam and topiramate in drug-resistant patients.