Abstracts

The use of extended release formulation antiepileptic medications has the advantage of once daily dosing, but requires the ability to swallow the tablet without chewing. In pediatric patients with moderate mental retardation, the ability to swallow tablets potentially limits the use of extended release formulations. This study was designed to evaluate the ability of caregivers to teach pediatric patients with moderate mental retardation to swallow Depakote ER tablets., Pediatric patients taking stable dose Depakote Sprinkles tablets with moderate mental retardation were recruited to participate in a clinical trial which involved transition to Depakote Extended Release (Depakote ER) tablets. A structured protocol to teach patients to swallow tablets was implemented for 4 weeks. Depakote ER tablets were then introduced. The ability to swallow tablets consistently without chewing was the primary outcome measure. Trough serum valproic acid levels were measured prior to transition, and 2-4 weeks post trasition. Child Behavior Checklist (CBCL) and adaptive behavior rating scales were completed initially and at the completion of the 8 week trial., Ten subjects (6 male) with moderate mental retardation (IQ between 40-60) age 11.1 years (mean 7-17 years) were recuited. Two were nonverbal, one was autistic, and one had a tracheostomy. Nine of 10 successfully learned to consistently swallow the tablets in 4 weeks; the last learned in several months. The valproic acid level was stable and remained therapeutic in 5 patients. Three patients had a decrease in valproic acid level 2 weeks after transition, and 2 of those 3 had an increase in seizure frequency. In 2 patients the valproic acid levels were not measured due to a protocol violation. None of the patients had significant choking, gagging or refusal to swallow tablets., Patients with moderate mental retardation can learn to swallow Depakote ER tablets without chewing, allowing the transition from twice daily dosing of Depakote Sprinkles to once daily dosing of Depakote ER tablets. In this population, the convenience of once daily dosing for a chronic daily medication lessens the caregiver burden of medication administration and potentially improves compliance. Monitoring the valproic acid level prior to transition and 2-4 weeks later will ensure adequacy of trough valproic acid level. Developmental delay with moderate mental retardation and/or inability to speak should not preclude the use of extended release formulation of medications. A structured program to teach how to swallow tablets, and careful safety monitoring of patients, can result in successful use of once daily medication dosing., (Supported by Abbott Laboratries.)