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Early Vigabatrin Treatment Before Seizure Onset Decreased Interictal Epileptiform Discharges Over the Duration of the
Tarrant O McPherson1, E Martina Bebin2, Laura S Farach3
1Department of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.
Insights
Early vigabatrin treatment reduced interictal epileptiform discharges (IEDs) in infants with tuberous sclerosis complex by approximately 20% over three years. This effect was most pronounced in infants who did not develop epileptic spasms.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Trials
Background:
- Tuberous sclerosis complex (TSC) is a genetic disorder associated with epilepsy.
- Interictal epileptiform discharges (IEDs) on electroencephalography (EEG) are common in infants with TSC.
- The PREVeNT trial investigated early vigabatrin treatment versus placebo in TSC infants.
Purpose of the Study:
- To determine if early vigabatrin treatment impacts the presence of IEDs in infants with TSC over the first three years of life.
- To analyze the effect of vigabatrin on IEDs in relation to infantile spasms.
Main Methods:
- The PREVeNT trial randomized 72 infants with TSC based on IED presence.
- Participants underwent serial EEGs throughout the first three years of life.
- EEGs were reviewed by blinded electrophysiologists with adjudication for disagreements.
Main Results:
- A total of 793 EEGs were analyzed; IEDs were present in 33.5% of recordings.
- The early vigabatrin group showed a lower percentage of EEGs with IEDs (34.3%) compared to the placebo group (45.9%), P=0.0496.
- This reduction was primarily driven by infants without infantile spasms in the vigabatrin group (27.7% IEDs vs. 41.7% in placebo), P=0.0185. Infants with spasms had high rates of IEDs regardless of treatment.
Conclusions:
- Early vigabatrin treatment significantly decreased the proportion of EEGs with IEDs by approximately 20% over three years in infants with TSC.
- The beneficial effect of vigabatrin on IEDs was mainly observed in infants who did not develop epileptic spasms.
- Infants who developed spasms exhibited IEDs in over half of their EEGs, irrespective of the treatment arm.
Background:
The PREVeNT trial enrolled 72 infants with tuberous sclerosis complex using the presence of interictal epileptiform discharges (IEDs) on a one-h electroencephalography (EEG) to randomize into a trial of placebo versus early vigabatrin. Here, we ask if early vigabatrin impacts IED presence over the first 3 years of life.
Methods:
Participants underwent an EEG every 6 weeks/first year of life, every 3 months/second year of life and once at age 36 months. EEGs were reviewed by two treatment blinded electrophysiologists; if they disagreed, a third reader adjudicated.
Results:
Seven hundred ninety-three EEGs were recorded, with IEDs present in 33.5% and at a higher percentage in the placebo arm of the study (n = 27 participants, 45.9% of 296 EEGs) than in the early vigabatrin group (n = 29, 34.3% of 332 EEGs) P = 0.0496. Infantile spasm-free participants in the vigabatrin group drove this reduction: placebo n = 14/26 without spasms, 41.7% of EEGs had IEDs versus vigabatrin n = 23/29 without spasms, and 27.7% of EEGSs had IEDs, P = 0.0185. In contrast the placebo group with spasms n = 12/26 had 51.9% IED positive EEGs versus early vigabatrin n = 6/29 with spasms had 60.3% IED positive, P = 0.5182. Overall, participants with spasms n = 18 had a higher rate of EEGs with IEDs versus those without n = 37, 54.8% vs 33.0%, P = 0.0005.
Conclusions:
Early treatment with vigabatrin decreased by ∼20% the proportion of EEGs with IEDs over 3 years. Vigabatrin group participants who did not develop epileptic spasms drove this reduction. Participants who developed spasms in either group had IEDs in over half of their EEGs.
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