VIGABATRIN VS CARBAMAZEPINE MONOTHERAPY IN PATIENTS WITH NEWLY-DIAGNOSED EPILEPSY - A RANDOMIZED, CONTROLLED-STUDY

Objective: To evaluate the efficacy, safety, and cognitive effects of initial vigabatrin monotherapy compared with initial carbamazepine mon otherapy in patients with newly diagnosed epilepsy. Design: Open, rand omized, controlled design. Follow-up period of 12 months. Setting: Uni versity hospital with an epilepsy center. Patients: A total of 100 pat ients, aged 15 to 64 years, classified as suffering from partial seizu res and/or generalized tonic-clonic seizures were randomized to either vigabatrin or carbamazepine monotherapy. Fifty-nine patients with a s ingle epileptic seizure and no antiepileptic drug treatment served as a control population for objective safety measures. Outcome Measures: To evaluate the comparative efficacy and toxicity of vigabatrin and ca rbamazepine, the drug success rate (ie, the proportion of patients con tinuing successful treatment with the randomly assigned drug) after 12 months of steady-state treatment was used. To evaluate the safety of the drugs in addition to reported side effects, visual evoked potentia l recordings and neuropsychological evaluation were performed during f ollow-up Results: During the 12-month follow-up period, 60% of patient s receiving vigabatrin and carbamazepine were treated successfully. Vi gabatrin caused fewer side effects that required discontinuation of th erapy. However, vigabatrin had to be discontinuated more often owing t o lack of efficacy, and fewer of the successfully treated patients rec eiving vigabatrin achieved total freedom from seizures. Vigabatrin had no detrimental effects on cognitive functions. Retrieval from both ep isodic and semantic memory and flexibility of mental processing improv ed significantly in patients successfully treated with vigabatrin. Con clusion: Vigabatrin seems to be an effective and safe antiepileptic dr ug as primary monotherapy for epilepsy with fewer cognitive side effec ts than carbamazepine.