Superior Effectiveness of Levetiracetam over Phenobarbital for Infantile Nonsyndromic Epilepsy: A Prospective Multi-Center Observational Study
Abstract number :
2.291
Submission category :
7. Antiepileptic Drugs / 7C. Cohort Studies
Year :
2017
Submission ID :
344901
Source :
www.aesnet.org
Presentation date :
12/3/2017 3:07:12 PM
Published date :
Nov 20, 2017, 11:02 AM
Authors :
Zachary Grinspan, Weill Cornell Medicine, New York, NY, USA; Renee Shellhaas, University of Michigan; Jason Coryell, Oregon Health Sciences University; Joseph Sullivan, UCSF Medical SChool; Elaine C. Wirrell, Mayo Clinic Rochester; John R. Mytinger, Natio
Rationale: Levetiracetam and phenobarbital are commonly used medications for infants with nonsyndromic epilepsies (i.e., EEG and clinical features that do not conform to known electroclinical syndromes). Their comparative effectiveness is unknown. Methods: We performed a prospective observational cohort study comparing the effectiveness of levetiracetam to phenobarbital for nonsyndromic epilepsy among infants with the first seizure between one month and one year of age, using the Early Life Epilepsy Study from 17 US medical centers. The binary outcome was freedom from failure of monotherapy after six months: (1) no second anti epileptic seizure drug for six months, and (2) no seizures for three months after three months of treatment. We adjusted for demographics, epilepsy characteristics, and neurologic history. We adjusted for observable selection bias using propensity scoring and for center effects using generalized estimating equations. Results: Bivariate analyses showed that infants treated with levetiracetam (N=117) were older at the time of the first seizure than those treated with phenobarbital (N=38) (median 5.2 [interquartile range 3·5 – 8·2] vs. 3·0 [2·0 – 4·4] months, p < 0·001). There were no other significant bivariate differences. Infants treated with levetiracetam were free from failure of monotherapy more often than those treated with phenobarbital (47 of 117 (40%) compared to 6 of 38 (16%); p = 0·01.) The superiority of levetiracetam over phenobarbital persisted after adjusting for covariates, observed selection bias, and center effects: odds ratio 6.2 [95% confidence interval 1·04 - 38]; number needed to treat 2·6 [1·4 - 197]. Conclusions: Levetiracetam has superior effectiveness over phenobarbital for initial monotherapy of nonsyndromic epilepsies in infants. One additional infant would be free from failure of monotherapy for every 2·6 infants treated with levetiracetam instead of phenobarbital. Randomized clinical trials are necessary to confirm these findings. Funding: .Funded by The Pediatric Epilepsy Research Foundation.
Antiepileptic Drugs