Levetiracetam offers greater efficacy than phenobarbital in preventing monotherapy failure in infants with nonsyndromic epilepsy, according to the findings of a multicenter prospective observational study published in JAMA Pediatrics.
Investigators evaluated a total of 155 infants with nonsyndromic epilepsy who were treated with levetiracetam (n=117) or phenobarbital (n=38) as initial monotherapy within 1 year of the first afebrile seizure. Infants were treated in 17 US pediatric epilepsy centers during a 3-year period (2012 to 2015). A 6-month freedom from monotherapy failure, as defined by seizure freedom within 3 months of treatment initiation and no additional prescribed antiepileptic medication, comprised the binary outcome.
Infants treated with levetiracetam were significantly older than infants managed with phenobarbital at the time of the first seizure (median age, 5.2 months [interquartile range, 3.5-8.2 months] vs 3.0 months [interquartile range, 2.0-4.4 months]; P <.001). Levetiracetam treatment was associated with greater freedom from monotherapy failure than phenobarbital treatment (40.2% vs 15.8%, respectively; P =.01). After adjustment for observable selection bias, covariates (ie, demographic and clinical), and within-center correlations, levetiracetam superiority to phenobarbital was sustained (odds ratio 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
The investigators note that more outcomes data were missing from the levetiracetam-treated group than the phenobarbital-treated group, which possibly resulted in some study bias. In addition, a follow-up period longer than 6 months may be of greater clinical importance in this patient population.
Findings from this research is “particularly relevant given the mismatch between current practice and regulatory approval for levetiracetam in infantile seizures.”
Grinspan ZM, Shellhaas RA, Coryell J, et al. Comparative effectiveness of levetiracetam vs phenobarbital for infantile epilepsy [published online February 12, 2018]. JAMA Pediatr. doi:10.1001/jamapediatrics.2017.5211