OP52 – 2694: The ketogenic diet versus ACTH in the treatment of infantile spasms: A prospective randomised study

Abstract

Objective The prognosis of infantile spasms (IS) is usually unfavorable with respect to treatment and developmental outcomes. The antiepileptic drugs (AEDs) most likely to be effective in the short-term management (complete cessation of spasm and EEG normalization) are ACTH and Vigabatrin, but there is insufficient evidence that these drugs also improve long-term outcomes. Both drugs have shown serious (irreversible and in part lethal) side effects. The ketogenic diet (KD) is licensed for drug-resistant epilepsy including IS as second-line treatment. Aim of this randomized, prospective study was to evaluate the efficacy and tolerability of the KD compared with ACTH. Methods All infants with IS referred to the Medical University of Vienna between June 2008 and September 2014 who were eligible for both treatments were included and randomized to either ACTH or the KD (liquid formula) after informed consent. When failure to the first treatment occurred (seizures and/or persistent hypsarrhyhtmia), patients were switched to the alternative treatment. Seizure and developmental outcomes as well as side effects were evaluated at 12 months after treatment initiation. Results 32 children were randomized (16 ACTH/16 KD). 9/16 randomized to the KD became seizure free (56%), with recurrence of seizures in 3 (18%) after 6 months. 7 (44%) did not respond. 10 non-responders were then switched to ACTH and further 4 children became seizure free (40%). The KD was well tolerated. 10/16 patients randomized to ACTH (62%) became seizure free and 3 (18%) relapsed, 6 (38%) did not respond. 6 patients were then switched to the KD and one child became seizure free (16%). 14/16 children on ACTH children showed severe side effects. Conclusion No differences in responder rates or in efficacy were observed between the KD and ACTH. However, compliance was better in the KD group and no severe side effects were observed.