Effect of Lisdexamfetamine Dimesylate on Parent-Rated Measures in Children Aged 6 to 12 Years With Attention-Deficit/Hyperactivity Disorder: A Secondary Analysis

Abstract

Objective: To evaluate the efficacy of lisdexamfetamine dimesylate (LDX) in school-aged children with attention-deficit/hyperactivity disorder (ADHD), using the Conners' Parent Rating Scale, Revised Short Version (CPRS-R: S) and its subscales. Methods: This was a secondary post hoc analysis of data from a placebo-controlled, double-blind, parallel-group, forced doseescalation trial. Boys and girls aged 6 to 12 years with a primary diagnosis of ADHD were randomly assigned to LDX (30, 50, or 70 mg/d) or placebo. Improvement on the CPRS-R: S and its subscales (ADHD Index, hyperactivity, appositional, and cognition) at 10: 00 AM, 2: 00 PM, and 6: 00 PM was analyzed. Safety assessments included the identification of adverse events and were conducted throughout the study. Results: Of the 290 patients randomized, 285 were included in the intent-to-treat population. Parents noted significant improvements at all 3 assessment times on the CPRS-R: S total score and for the CPRS-R: S ADHD Index, hyperactivity, and cognition subscales, regardless of the subject baseline disease severity. For the CPRS-R: S appositional subscale, significant improvement was noted at 10: 00 AM and 2: 00 PM (P < 0.01), and overall, significant improvement occurred in subjects who were more severely ill at baseline. The tolerability of LDX was comparable to that of other stimulants. Conclusion: Once-daily treatment with LDX was associated with significant improvement in parent-rated assessments of AD HO-related behavior throughout the day at approximately 10: 00 AM, 2: 00 PM, and 6: 00 PM. Lisdexamfetamine dimesylate was effective and well tolerated in this study population of children aged 6 to 12 years with ADHD.