EPA-0719 – Post hoc analyses on the efficacy of lisdexamfetamine dimesylate following previous treatment with attention deficit/hyperactivity disorder medication

Abstract

The prodrug lisdexamfetamine dimesylate (LDX) is licensed in several European countries for treating attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with an inadequate response to methylphenidate (MPH) treatment. To evaluate post hoc the impact of ADHD medication history on the efficacy of LDX. In this 7-week, dose-optimized, double-blind, study, patients (6–17 years) were randomized 1:1:1 to LDX, placebo or osmotic-release oral system methylphenidate (OROS-MPH). Efficacy assessments included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scores. The full analysis set (FAS) comprised 317 patients. Baseline characteristics were similar across treatment groups and previous treatment subgroups. At endpoint, the mean change from baseline in ADHD-RS-IV total score and proportions of responders based on a CGI-I of 1 or 2 for LDX, OROS-MPH and placebo are presented below. Previous treatment sub-group LDX Placebo OROS-MPH Mean change (SD) in ADHD-RS-IV total score FAS (N=317) −24.7 (10.15) −6.3 (10.02) −18.9 (12.92) Treatment-naïve (n=147) −24.0 (10.00) −8.5 (10.34) −21.4 (13.09) Any previous ADHD medication (n=170) −25.3 (10.34) −4.2 (9.30) −16.9 (12.53) Previous MPH treatment (n=146) −25.4 (10.67) −4.7 (9.70) −17.7 (11.96) Proportion of responders (95% CI): CGI-I 1 or 2 FAS (N=317) 78.0% (69.9, 86.1) 14.4% (7.7, 21.2) 60.6% (51.2, 70.0) Treatment-naïve (n=147) 80.4% (69.0, 91.9) 19.6% (8.7, 30.5) 63.8% (50.1, 77.6) Any previous ADHD medication (n=170) 75.9% (64.5, 87.3) 9.4% (1.6, 17.3) 57.9% (45.1, 70.7) LDX and OROS-MPH were associated with clinically relevant improvements in ADHD symptoms irrespective of ADHD medication history. Study funded by Shire