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- Title
Comparative Effectiveness of Levetiracetam vs Phenobarbital for Infantile Epilepsy.
- Authors
Grinspan, Zachary M.; Shellhaas, Renée A.; Coryell, Jason; Sullivan, Joseph E.; Wirrell, Elaine C.; Mytinger, John R.; Gaillard, William D.; Kossoff, Eric H.; Valencia, Ignacio; Knupp, Kelly G.; Wusthoff, Courtney; Keator, Cynthia; Ryan, Nicole; Loddenkemper, Tobias; Chu, Catherine J.; Novotny, Edward J.; Millichap, John; Berg, Anne T.
- Abstract
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]; <italic>P</italic> <.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%]; <italic>P</italic> =.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.This multicenter cohort study compares the effectiveness of levetiracetam vs phenobarbital for nonsyndromic infantile epilepsy.Key Points: Question: Is there a difference in effectiveness between levetiracetam and phenobarbital, the 2 most commonly prescribed medications for nonsyndromic epilepsy in infants? Finding: In this multicenter cohort study of 155 infants with nonsyndromic epilepsy, freedom from monotherapy failure at 6 months was significantly more common for children treated with levetiracetam (40.2%) than those treated with with phenobarbital (15.8%). The observed superiority of levetiracetam compared with phenobarbital persisted after controlling for covariates, observable selection bias, and correlation of outcomes within centers. Meaning: These findings provide novel evidence to favor levetiracetam instead of phenobarbital for initial monotherapy of infantile nonsyndromic epilepsy, although randomized clinical trials are needed to confirm the results.
- Subjects
ANTICONVULSANTS; PHENOBARBITAL; CONFIDENCE intervals; SEIZURES (Medicine); EPILEPSY; LONGITUDINAL method; MEDICAL cooperation; SCIENTIFIC observation; PROBABILITY theory; RESEARCH; SPASMS; TREATMENT effectiveness; RESEARCH bias; ODDS ratio; CHILDREN; THERAPEUTICS
- Publication
JAMA Pediatrics, 2018, Vol 172, Issue 4, p352
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2017.5211