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Download fileDose Effects and Comparative Effectiveness of Extended Release Dexmethylphenidate and Mixed Amphetamine Salts
journal contribution
posted on 2012-07-24, 00:00 authored by Mark A. Stein, Irwin D. Waldman, Elizabeth Charney, Subhash Aryal, Craig Sable, Reut Gruber, Jeffrey H. NewcornObjective: 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.