Russian observational study of the efficacy and tolerability of depakine chrono as first-linemonotherapy for focal epilepsy

Abstract

Objective: to evaluate the efficacy and tolerability of sustained-release sodium valproate sodium as first-line monotherapy in patients with newly or recently diagnosed focal epilepsy. Subjects and methods. This was an open-label, prospective, observational study performed in the real treatment setting. It covered 1580 patients (children older than 6 years and adults) with focal epilepsy. The patients received sustained-release sodium valproate in an average daily dose of 1268 mg for 6 months. Therapeutic effectiveness was evaluated from remission rates when the study was completed. Moreover, the proportion of patients who continued to take the drug following 6 months was estimated. The total efficiency of the therapy was evaluated by the Clinical Global Impression Scale (CGI). Results. At 6 months of the study, 1478 (93.5%) patients continued to take the drug, 1167 (73.9%) of the 1580 patients achieved remission (they were seizure-free). The drug proved to be effective in all types of epileptic seizures of different etiology and different localization of an epileptic focus. In complex partial seizures and secondary generalized seizures, the efficiency of sustained-release sodium valproate was somewhat higher than that in simple partial seizures [71.1% (477/672), 74% (853/1153), and 68.4% (476/697), respectively]. During treatment, 67.9% (1072/1580) of the patients showed an evident and significant improvement without side effects. The drug was well tolerated. Drug-induced side effects were observed in 139 (8.8 %) of the 1580 patients; these were mild and moderate and led to drug discontinuation in only 10 (0.6%) of the 1580patients. The most adverse events were weight gain in 1.8% (29/1580) of the patients, alopecia in 1.8% (28/1580), and tremor in 1.5% (25/1580). Conclusion. The study indicates that the use of sustained-release sodium valproate is an effective and well tolerable first-line drug for the treatment of focal epilepsy in children and adults.