Dose effects and comparative effectiveness of extended release dexmethylphenidate
and mixed amphetamine salts.
Author(s): Stein MA, Waldman ID, Charney E, Aryal S, Sable C, Gruber R, Newcorn JH.
Affiliation(s): Institute for Juvenile Research, University of Illinois, Chicago, Illinois 60608,
USA. mstein@uic.edu
Publication date & source: 2011, J Child Adolesc Psychopharmacol. , 21(6):581-8
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 ER MAS
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.
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