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Comparative Effectiveness of Levetiracetam vs Phenobarbital for Infantile Epilepsy
Zachary M Grinspan1,2,3, Renée A Shellhaas4, Jason Coryell5,6
1Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, New York.
Insights
Levetiracetam may be more effective than phenobarbital for treating infant nonsyndromic epilepsy. This study suggests levetiracetam offers better initial monotherapy outcomes for infants with this condition.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Over half of infants with new-onset epilepsy present with nonsyndromic epilepsy, lacking defined electroclinical features.
- Levetiracetam and phenobarbital are common initial treatments, but their comparative effectiveness is not well-established.
Purpose of the Study:
- To compare the effectiveness of levetiracetam versus phenobarbital as initial monotherapy for infants with nonsyndromic epilepsy.
Main Methods:
- A prospective, multicenter observational cohort study (Early Life Epilepsy Study) enrolled 155 infants (1 month to 1 year) with nonsyndromic epilepsy.
- Effectiveness was measured by freedom from monotherapy failure at 6 months, defined by no need for a second antiepileptic drug and seizure freedom within 3 months of treatment initiation.
- Statistical adjustments included propensity score weighting for selection bias and generalized estimating equations for within-center correlation.
Main Results:
- Infants treated with levetiracetam (n=117) were older at first seizure than those on phenobarbital (n=38).
- Levetiracetam showed a higher rate of freedom from monotherapy failure (40.2% vs 15.8%; P=.01).
- This superiority persisted after adjusting for covariates and bias, with an odds ratio of 4.2 (95% CI, 1.1-16).
Conclusions:
- Levetiracetam may be more effective than phenobarbital for initial monotherapy in infants with nonsyndromic epilepsy.
- The findings suggest that for every 100 infants treated with phenobarbital, an additional 28 might achieve monotherapy success with levetiracetam.
- Further randomized clinical trials are needed to confirm these findings.
Importance:
More than half of infants with new-onset epilepsy have electroencephalographic and clinical features that do not conform to known electroclinical syndromes (ie, nonsyndromic epilepsy). Levetiracetam and phenobarbital are the most commonly prescribed medications for epilepsy in infants, but their comparative effectiveness is unknown.
Objective:
To compare the effectiveness of levetiracetam vs phenobarbital for nonsyndromic infantile epilepsy.
Design, Setting, And Participants:
The Early Life Epilepsy Study-a prospective, multicenter, observational cohort study conducted from March 1, 2012, to April 30, 2015, in 17 US medical centers-enrolled infants with nonsyndromic epilepsy and a first afebrile seizure between 1 month and 1 year of age.
Exposures:
Use of levetiracetam or phenobarbital as initial monotherapy within 1 year of the first seizure.
Main Outcomes And Measures:
The binary outcome was freedom from monotherapy failure at 6 months, defined as no second prescribed antiepileptic medication and freedom from seizures beginning within 3 months of initiation of treatment. Outcomes were adjusted for demographics, epilepsy characteristics, and neurologic history, as well as for observable selection bias using propensity score weighting and for within-center correlation using generalized estimating equations.
Results:
Of the 155 infants in the study (81 girls and 74 boys; median age, 4.7 months [interquartile range, 3.0-7.1 months]), those treated with levetiracetam (n = 117) were older at the time of the first seizure than those treated with phenobarbital (n = 38) (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). There were no other significant bivariate differences. Infants treated with levetiracetam were free from monotherapy failure more often than those treated with phenobarbital (47 [40.2%] vs 6 [15.8%]; P = .01). The superiority of levetiracetam over phenobarbital persisted after adjusting for covariates, observable selection bias, and within-center correlation (odds ratio, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Conclusions And Relevance:
Levetiracetam may have superior effectiveness compared with phenobarbital for initial monotherapy of nonsyndromic epilepsy in infants. If 100 infants who received phenobarbital were instead treated with levetiracetam, 44 would be free from monotherapy failure instead of 16 by the estimates in this study. Randomized clinical trials are necessary to confirm these findings.
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