Long-term use of Levetiracetam in patients with severe childhood-onset epilepsy.
OBJECTIVE
To assess the efficacy and tolerability of Levetiracetam (LEV) in children and adolescents with refractory epilepsy with a special interest in the long-term retention rate.


METHODS
One hundred and twenty-nine patients (83 male, 46 female; mean age 10.6 years/range: 6 months-39 years 9 months) were included in a prospective, open-label, add-on trial of LEV for up to 3 years. All patients had severe forms of epilepsy starting before the age of 10 often accompanied by mental retardation. Primary outcome measures were changes in seizure frequency after 6 months on the medication with LEV, with initial responders (>50% seizure reduction). Further objective was the retention rate of LEV therapy after 3 years defined as percentage of patients still taking LEV.


RESULTS
Thirty-five patients (27.1%) were initial responders of which 5 became seizure free. The average maximum LEV dosage was 39.8 mg/kg/day (range: 6-70 mg/kg/day) with no difference responders vs. no responders. The retention rate for responders after 3 years was 22.5%. The rate of side effects was 39.8% in all patients, with the most frequent side effects being fatigue (12.5%), aggressiveness (7.8%) and gastrointestinal disorders (13.3%).


CONCLUSIONS
Our study in patients with refractory epilepsy suggests that our initial responders were very likely to be still taking LEV after 3 years. We therefore consider treatment with LEV in this special group of patients with refractory epilepsy a promising therapeutic option, because of its favourable tolerance profile, the option of fast titration and the absence of drug interactions.
von Stuelpnagel
Celina
C
Department of Paediatrics, Hospital Munich-Harlaching, Sanatoriumsplatz 2, 81545 Harlaching, Germany. celina1@gmx.de
Holthausen
Hans
H
Kluger
Gerhard
G
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D000077287:Levetiracetam; D008137:Longitudinal Studies; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam