A community assessment, open-label study of the safety, tolerability, and effectiveness of mixed amphetamine salts extended release in school-age children with ADHD

Abstract

Objective: To assess the safety, tolerability, and effectiveness of mixed amphetamine salts extended release (MAS XR) in school-age children with attention-deficit/hyperactivity disorder (ADHD) treated in a community practice setting.

Methods: Children aged 6-12 years (N = 2968) with DSM-IV-defined ADHD entered a 9-week prospective, open-label, non-comparative study of MAS XR at 386 sites. For at least 2 weeks before enrollment, subjects with well-controlled ADHD received their consistent dose of previously prescribed psychostimulant. Subsequently, this regimen was converted to an equivalent once-daily dose of 10-, 20-, or 30-mg MAS XR, according to a conversion algorithm. Tolerability and safety were assessed based on reported treatment-emergent adverse events and observed changes in vital signs and body weight. Effectiveness was assessed using a parent-completed Conners' Global Index Scale (CGIS-P) measured 8 and 12 h postdose and a clinician-scored Clinical Global Impressions-Improvement (CGI-I) scale after 1, 3, and 7 weeks of treatment. The dose of study medication could be adjusted at weeks 1 and 3 to a maximum of 40 mg/day. Outcome analyses used an intent-to-treat methodology, with last observations carried forward.

Results: Statistically significant improvement in ADHD behavior 8 and 12 h postdose occurred during the first week of treatment and was maintained through study endpoint (p < 0.0001). Results of the investigator-rated CGI-I at weeks 1, 3, and 7 were consistent with the parent-rated CGIS-P results, indicating that MAS XR treatment significantly improved symptoms compared with the baseline stimulant regimen (p < 0.0001). The incidence of treatment-related adverse events was low, and most AEs were mild in intensity.

Conclusion: MAS XR 10-40 mg is a safe and effective once-daily medication for treatment of children with ADHD in a community practice setting. ADHD symptoms may be further reduced by converting from current pharmacotherapy to an optimally titrated dose of MAS XR.