Neuropediatrics 2006; 37 - THP134
DOI: 10.1055/s-2006-945957

LEVETIRACETAM: 2 YEARS EXPERIENCE IN CHILDREN

E Franzoni 1, J Sarajlija 1, C Garone 1, C Celotti 1, I Cecconi 1, V Marchiani 1, E Malaspina 1, FC Moscano 1
  • 1Child Neuropsychiatry Unit, Polyclinic S.Orsola-Malpighi, University of Bologna, Italy

Purpose: Levetiracetam (LEV) is recently licensed for paediatric use. We evaluated its efficacy and tolerability in our paediatric population.

Methods: 48 patients with refractory epilepsy were included; 3 were later excluded with <1 month follow-up. LEV's efficacy was assessed by seizure frequency reduction and tolerability by adverse event (AE) reporting.

Results: 45 (31 male, 14 female) patients, mean age 11 years 4 months were analysed. 32 (66.7%) had partial epilepsy with secondary generalisation; 5 (11.1%) simple partial, 4 (8.9%) complex partial, 6 (13.3%) generalised-onset seizures; of these 2 patients had more than one seizure type. 6/45 patients received LEV monotherapy, 2 with primary generalised seizures.

In 18 (39.6%) children seizure frequency decreased by ≥25%, 11/45 (24.5%) achieving seizure freedom. 29/48 (60.4%) patients experienced no seizure reduction, 4/48 (13.8%) showed initial improvement. 6/48 (12.5%) patients experienced seizure worsening. In 4 children aged <4 years, LEV was discontinued for lack of efficacy or seizure worsening. LEV appeared less effective when combined with topiramate. Responders received lower mean doses (33.9mg/kg/day) than non-responders (49.5mg/kg/day). Mean doses were 25.7mg/kg/day in seizure-free; 36.5mg/kg/day in ≥50% responders; 45.7mg/kg/day in ≥25% responders; 40.4mg/kg/day in non-responders. Patients with seizure worsening received 64.5mg/kg/day in non-responders. Moderate AEs were reported in 15 (31.2%) patients, not requiring, LEV discontinuation.

Conclusion: Our study showed LEV as effective and well tolerated in nearly 40% of our patients and supports widespread evidence of LEV's broad spectrum of activity and good safety profile.