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Dose Effects and Comparative Effectiveness of Extended Release Dexmethylphenidate and Mixed Amphetamine Salts
journal contributionposted on 2012-07-24, 00:00 authored by Mark A. Stein, Irwin D. Waldman, Elizabeth Charney, Subhash Aryal, Craig Sable, Reut Gruber, Jeffrey H. Newcorn
Objective: To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity disorder (ADHD) symptom dimensions, global and specific impairments, and common adverse events associated with stimulants. Methods: Fifty-six children and adolescents with ADHD participated in an 8-week, double-blind, crossover study comparing ER d-MPH (10, 20, 25–30 mg) and ER MAS (10, 20, 25–30) with a week of randomized placebo within each drug period. Efficacy was assessed with the ADHD Rating Scale-IV (ADHD-RS-IV), whereas global and specific domains of impairment were assessed with the Clinical Global Impressions Severity and Improvement Scales and the parent-completed Weiss Functional Impairment Scale, respectively. Insomnia and decreased appetite, common stimulant-related adverse events, were measured with the parent-completed Stimulant Side Effects Rating Scale. Results: Both ER d-MPH and ER MAS were associated with significant reductions in ADHD symptoms. Improvement in Total ADHD and Hyperactivity/Impulsivity symptoms were strongly associated with increasing dose, whereas improvements in Inattentive symptoms were only moderately associated with dose. About 80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ERMAS compared with 79% when receiving ER d-MPH. Decreased appetite and insomnia were more common at higher dose levels for both stimulants. Approximately 43% of the responders were preferential responders to only one of the stimulant formulations. Conclusions: Dose level, rather than stimulant class, was strongly related to medication response.
Financial Support: Investigator-initiated study sponsored by Novartis Pharmaceuticals, with additional support provided by the University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS), Award Number UL1RR029879 from the National Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
Publisher StatementThis is a copy of an article published in the Journal of Child and Adolescent Psychopharmacology © 2011 Copyright Mary Ann Liebert, Inc.; Journal of Child and Adolescent Psychopharmacology is available online at: http://www.liebertonline.com. DOI: 10.1089/cap.2011.0018
PublisherMary Ann Liebert