Abstracts

Rationale: Evaluate efficacy and tolerability of a whey-based, ketogenic formula with medium-chain triglycerides (MCT) in children with refractory epilepsy compared to other published data using classic ketogenic diet therapies in pediatric epilepsy. Methods: Data from pediatric patients with refractory epilepsy who were treated with ketogenic diet therapy (KDT) between 01/01/2015 and 02/28/2018 were analyzed retrospectively. Patients included were those who were treated with a whey-based, MCT-enhanced, ketogenic formula (KetoVie 4:1TM, Cambrooke Therapeutics, Ayer, MA) and continuous 3-month follow-up. Outcome measures included gastrointestinal issues, acidosis, serum blood glucose, serum beta-hydroxybutyrate, unintentional weight changes, diet responsiveness, and seizure-freedom. Data on outcome measures for comparison between MCT-enhanced ketogenic formula and classic ketogenic diet were obtained from published research on classic KDT in pediatric patients within the last 10 years.  Results: Data from 26 patients (13 male, mean age 6.1 +- 5.8 years) were analyzed. Of the 26 patients, 13 were existing patients (EPs) who were established on ketogenic formula before changing to KetoVie 4:1TM; 13 were new patients (NPs) who were initiated on KDT using KetoVie 4:1TM. The formula was well-tolerated in all patients. No patients in either group discontinued KetoVie 4:1TM by 3 months. The combined diet-response rate for both EPs and NPs was 96%, which was higher than the rate of 47% calculated for other published data on classic ketogenic diets in pediatric patients with epilepsy (95% CI 80.0-100.0 versus 43.0-50.0). Constipation prevalence was higher in patients receiving KetoVie 4:1TM than classic KDT (69% [95% CI 48.0-86.0] vs 25% [20.0-30.0], respectively), although the vomiting prevalence was lower (8% [95% CI 1.0-25.0] vs 31% [25.0-37.0], respectively). Conclusions: Our study demonstrates diet responsiveness and formula tolerability for patients on KetoVie 4:1TM is similar if not improved, as compared to other published data in the last 10 years. Funding: Financial support for this project was provided by Ajinomoto Cambrooke.