[Efficacy and safety of adjunctive levetiracetam in children younger than 4 years with refractory epilepsy].
OBJECTIVE
To evaluate of the efficacy and safety of adjunctive levetiracetam (LEV) in children younger than 4 years with refractory epilepsy.


METHODS
One hundred and twelve children at age of 4 months to 4 years with refractory epilepsy received LEV as adjunctive therapy. LEV was administered in two equal daily doses of 10 mg/kg. The dose was increased by 10 mg/kg every week up to the target dose (20-40 mg/kg). The efficacy and tolerability were evaluated.


RESULTS
At an average follow-up period of 13 months (6-22 months), LEV administration was found to be effective in 43 children (38.4%) (responders showing more than a 50% decrease in seizure frequency) and 14 children (12.5%) became seizure-free. Fifty-three children (47.3%) did not respond to the treatment and 2 children (1.8%) worsened. The therapy-related adverse events were mild, including restlessness, reduction in sleep time, night terrors, debility, somnolence, nausea and vomiting. The adverse events were either tolerable or resolved in time with dosage reduction in most of children, and only 3 cases required discontinuation.


CONCLUSIONS
LEV as adjunctive therapy is effective and well-tolerated in children younger than 4 years with refractory epilepsy, suggesting that it represents a valid option for the treatment of refractory epilepsy in this age group.
Hu
Yan
Y
Department of Pediatric Neurology & Epilepsy Center, Shenzhen Children's Hospital, Shenzhen, Guangdong 518026,China.
Liao
Jian-Xiang
JX
Chen
Li
L
Huang
Tie-Shuan
TS
Li
Bing
B
D000927:Anticonvulsants / Q000627:therapeutic use*; D002675:Child, Preschool; D004827:Epilepsy / Q000188:drug therapy; D005260:Female; D006801:Humans; D007223:Infant; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam