In the November 21, 2012, issue of the journal, Epilepsia, Drs. Glauser and a team from the Childhood Absence Epilepsy Study Group presented an important analysis from the results of a multi-center study, assessing which is the best initial drug for children with newly diagnosed childhood absence epilepsy based on a randomized, controlled, double-blind protocol.
Despite the fact that lamotrigine, valproic acid and ethosuximide are commonly utilized for treatment of children with childhood absence epilepsy, there has never been a study that has compared which of those agents may be superior for the management of this condition when utilized as the sole drug.
The researchers utilizing a double-blind, randomized, controlled clinical trial compared the efficacy, tolerability and neuropsychological effects of ethosuximide, valproic acid and lamotrigine in children with newly diagnosed childhood absence epilepsy. Study medications were titrated to a clinical response and subjects remained in the trial unless they reached a treatment failure. The target dose was ethosuximide 60 mg/kg/day or 2000 mg a day; valproic acid 60 mg/kg/day or 3000 mg per day vs. lamotrigine 12 mg/kg/day or 600 mg/day. The main outcome was the freedom from seizure rate 12 months after randomization and included video EEG assessment. Differential side effects were determined by pairwise comparisons. The main cognitive outcome was a percentage of subjects experiencing attentional dysfunction at the 12-month visit.
The study conducted at numerous epilepsy centers included 453 children.
By 12 months after starting therapy, 37% of all subjects were free from treatment failure on their first medication.
At the 12-month visit, the freedom from failure rates for ethosuximide and valproic acid were similar, 45% and 44% respectively; however, were higher than the rate for lamotrigine control at 21%.
The frequency of treatment failure due to lack of seizure control and intolerable side effects were significantly different amongst these groups. Two-thirds of 125 subjects with treatment failure due to lack of seizure control were in the lamotrigine treatment group.
The largest group, or 42% of 115 subjects, discontinuing were due to side effects in the valproic acid group. Previously reported higher rates of attentional dysfunction seen at 16-20 weeks in the valproic acid group compared with the ethosuximide and lamotrigine groups and persisted at one-year mark.
The investigators concluded, that as initial monotherapy, the effectiveness of ethosuximide and valproic acid compared to lamotrigine in controlling seizures without intolerable adverse effects noted at 16 to 20 weeks persisted at 12 months.
The valproic acid cohort experienced a higher rate of side effects leading to drug discontinuation as well as significant negative effects on attentional measures that were not seen in the ethosuximide cohort. These 12-month outcome data coupled with the study’s decision-making algorithm indicate that ethosuximide is the optimal initial therapy for childhood absence epilepsy. This is the first randomized trial meeting criteria for class I evidence for childhood absence epilepsy.
Why is this Important?
This study is important and will be cited frequently given its significant finding.
This is a clear indication that when a child is diagnosed with childhood absence epilepsy, ethosuximide is the superior choice compared to valproic acid and lamotrigine.
It does not mean that valproic acid or lamotrigine could not be utilized, it is just important to understand that if a choice exists, that ethosuximide appears to be the best opportunity for good control with fewer adverse effects.
by Joseph I. Sirven, MD
Last Reviewed: 12/19/2012
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