Early Vigabatrin Treatment Before Seizure Onset Decreased Interictal Epileptiform Discharges Over the Duration of the PREVeNT Study.
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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.