EPA-0775 – Efficacy of lisdexamfetamine dimesylate and atomoxetine in child and adolescent subgroups from a head-tohead, double-blind, randomized trial in patients with attention-deficit/hyperactivity disorder

Abstract

Symptoms of attention-deficit/hyperactivity disorder (ADHD) appear in childhood and may persist into adolescence and beyond. Evaluate the efficacy of lisdexamfetamine dimesylate (LDX) and atomoxetine in subgroups of children and adolescents with ADHD. In this 9-week, double-blind study, patients aged 6–17 with ADHD and an inadequate response to previous methylphenidate therapy were randomized (1:1) to optimized doses of LDX or atomoxetine. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) total score and dichotomized Clinical Global Impressions-Improvement (CGI-I) score (improved, 1–2; not improved, 3–7). The full analysis set (n=262) comprised 194 children aged 6–12 (LDX, n=93; atomoxetine, n=101) and 68 adolescents aged 13–17 (LDX, n=34; atomoxetine, n=34). Mean optimized doses were: LDX, 52.5 (SD, 16.10) mg/day; atomoxetine, 40.2 (20.05) mg/day. Baseline mean ADHD-RS-IV total score was similar across treatment and age groups. Table shows efficacy results; safety profiles were consistent with previous studies. LDX Atomoxetine Mean change in ADHD-RS-IV total score by visit 9 (95% confidence interval) Overall −26.3 (−28.4, −24.2) −19.4 (−21.6, −17.2) Children −27.5 (−29.8, −25.1) −19.4 (−22.0, −16.7) Adolescents −22.9 (−27.3, −18.5) −19.5 (−23.7, −15.3) Patients (%) with improved CGI-I score by visit 9 (95% confidence interval) Overall 81.7 (75.0, 88.5) 63.6 (55.4, 71.8) Children 83.9 (76.4, 91.3) 61.2 (51.6, 70.9) Adolescents 75.8 (61.1, 90.4) 70.6 (55.3, 85.9) Within each treatment group, improvements in symptomatological scales and global improvement ratings were observed in children and adolescents. Study funded by Shire .