An open-label prospective clinical study of the efficacy and tolerability of brand-name and generic levetiracetam in the monotherapy of focal epilepsy in adults

Abstract

Objective: to comparatively evaluate the clinical efficacy and tolerability of monotherapy with levetiracetam (LEV), a brand-name drug (bLEV; Keppra, UCB Pharma, Belgium) and its generic (gLEV; Epiterra, TEVA, Israel) in adolescent (over 16 years of age) and adult patients with focal epilepsy (FE) during a one-year follow-up period.Patients and methods. The patients were divided into two groups: 1) bLEV (n = 143) and 2) gLEV (n = 63). Group 2 received monotherapy with gLEV at baseline, or was switched to it from another drug within the international nonproprietary name, or to LEV from monotherapy with another antiepileptic drug (AED) due to inefficiency and/or poor tolerability. The median doses of bLEV and gLEV were 1000 and 1500 mg/day, respectively.Results and discussion. The results of the clinical trial suggest that LEV shows high efficacy and excellent tolerance in FE therapy. The clinical efficacy of bLEV and gLEV at 12-month follow-up was high and amounted to 82.5% for the two dosage forms. The frequency of adverse events was 17.5% for both bLEV and gLEV. The median dose of LEV was 1000 mg/day for Group 1 and 1500 mg/day for Group 2. Higher LEV doses in Group 2 patients were probably due to their longer disease duration. All patients taking LEV had an excellent or good quality of life and, when switched from other AEDs, showed even an improvement. The comparability of clinical results suggests that there may be bLEV to gLEV and gLEV to bLEV switches, especially during forced drug supply disruptions; however, this substitution should be done only after mandatorily discussing this matter with the patient and telling him about all possible consequences of this substitution.