Effect of lisdexamfetamine dimesylate on parent-rated measures in children aged 6 to 12 years with attention-deficit/hyperactivity disorder: a secondary analysis.

ABSTRACT

UNLABELLED 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-RS) and its subscales. METHODS: This was a secondary post hoc analysis of data from a placebo-controlled, double-blind, parallel-group, forced dose-escalation 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-RS and its subscales (ADHD Index, hyperactivity, oppositional, and cognition) at 1000 AM, 200 PM, and 600 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-RS total score and for the CPRS-RS ADHD Index, hyperactivity, and cognition subscales, regardless of the subject baseline disease severity. For the CPRS-RS oppositional subscale, significant improvement was noted at 1000 AM and 200 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 ADHD-related behavior throughout the day at approximately 1000 AM, 200 PM, and 600 PM. Lisdexamfetamine dimesylate was effective and well tolerated in this study population of children aged 6 to 12 years with ADHD.