4.5 Article

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

Journal

POSTGRADUATE MEDICINE
Volume 120, Issue 3, Pages 89-102

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.3810/pgm.2008.09.1910

Keywords

ADHD; attention-deficit/hyperactivity disorder; duration; lisdexamfetamine dimesylate; prodrug medication; stimulant medication

Funding

  1. Shire Development, Inc.

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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 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-R:S and its subscales (ADHD Index, hyperactivity, oppositional, 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 oppositional 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 ADHD-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.

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