P03-332 - Effect of treatment with lisdexamfetamine dimesylate on self-reported quality of life in adults with attention-deficit/hyperactivity disorder

Abstract

ObjectiveTo assess the impact of lisdexamfetamine dimesylate (LDX; Vyvanse®, Shire US Inc.), which is the first long-acting prodrug stimulant indicated for treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults in the United States, on performance and quality of life (QOL) in adults with ADHD.MethodsSubjects (n=142; aged 18 to 55 years) with ADHD entered a 4-week open-label dose-optimisation phase, then a 2-week, double-blind crossover phase. The primary efficacy measure was the average postdose total score on the Permanent Product Measure of Performance (PERMP) math test given predose and 2, 4, 8, 10, 12, and 14 hours postdose. The Adult ADHD Impact Module (AIM-A) was self-administered during the dose-optimisation phase. Safety was assessed by monitoring adverse events (AEs).ResultsIn the intention-to-treat population (n=105), postdose average PERMP least squares mean (SE) scores were higher (P< .0001) for LDX (312.9 [8.59]) vs placebo (289.5 [8.59]) and at every postdose time point ≥14 hours (P≤.0017 for each). Mean change from baseline scores on AIM-A subscales (n=127) showed improvement (P< .001) with LDX in 6 measured QOL domains (living with ADHD; general wellbeing; work, home, and school performance and daily functioning; relationships and communication; interference with life; and concern caused by symptoms). Treatment-emergent AEs (≥10%) in the dose-optimisation phase were decreased appetite (36.6%), dry mouth (30.3%), headache (19.7%), and insomnia (18.3%).ConclusionsLDX improved QOL and performance (up to 14 hours) and demonstrated a safety profile consistent with long-acting stimulant use.Supported by funding from Shire Development Inc., Wayne, PA, US.