Safety and efficacy of levetiracetam in juvenile patients with focal epilepsy with and without secondary generalisation
The objective of this study was to assess the safety and efficacy of levetiracetam (LEV) (Keppra®) as add-on treatment in juvenile patients with focal epilepsy with or without secondary generalization over 6 months in a German prospective non-interventional study.
Patients with uncontrolled seizures received LEV. 3 and 6 months after inclusion the reduction of seizure frequency and the occurrence of adverse events (AE) were recorded. Quality of life (QoL) was assessed using the questionnaire E4.
The data of 176 subjects was available for safety analysis, 81 for efficacy analysis. The mean age of the patients was 10.7 years and the mean starting dose of LEV was 766mg/day, which was increased to a mean of 1,045mg/day after 3 months and 1,107mg/day after 6 months. 101 patients were treated in monotherapy, 75 as add-on therapy. Valproic acid, oxcarbazepine and lamotrigine were the most common additional used antiepileptic drugs.
Upon inclusion 81 patients presented with quantifiable seizures, the average frequency being 38.0 fits per month. After 3 and 6 months only 45 and 42 patients experienced seizures, reflected by a frequency of 22.3 fits per month after 3 months and 17.3 fits per month after 6 months. A reduction of seizures per month of at least 50% compared to the inclusion visit was documented for 60 and 58 patients after 3 and 6 months. On a scale from 1 to 5 (with 1 being the best) doctors and patients assessed treatment efficacy with average values of 2.26 and 2.4.
Within the 6 months reporting period AE were documented for 56 of 176 subjects (31.8%). The severity of AE was generally mild to moderate. 20 patients (11.4%) stopped therapy due to an AE. On a scale from 1 to 5 doctors and patients assessed the treatment tolerability with average values of 1.66 and 1.77.
58.3% of the patients reported increased seizure control after 6 months (QoL). Improvements of general quality of life, general health, attention and concentration were also reported.
Monotherapy and add-on therapy with levetiracetam were safe and effective in the treatment of juvenile patients with focal epilepsy.