Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD: A multicenter, randomized prospective study
Abstract
This community-based study was designed to evaluate treatment outcomes with OROS methylphenidate (MPH) and atomoxetine in children with attentiondeficit/hyperactivity disorder (ADHD), as assessed by physicians and parents in a setting that resembles clinical practice. In a multicenter, prospective, open-label study, children 6 to 12 years of age with ADHD were randomized (2:1, respectively) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine. Investigatorrated measures of symptoms included the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made at baseline and during a telephone interview in week 1, a clinic visit in week 2, and a final clinic visit in week 3. In total, 1323 patients received OROS MPH (n = 850) or atomoxetine (n = 473). Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine. At the end of the study, mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine (P < .001). Between-treatment differences appeared to increase over time (2.77, 3.44, and 4.24 at weeks 1, 2, and 3, respectively; P < .001). Treatment response (ie, 25% reduction from baseline ADHD-RS scores) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine (P < .001). Similar percentages of patients taking OROS MPH (4.8%) and atomoxetine (5.5%) withdrew because of adverse events. Although community-based studies often lack the control of randomized, placebo-controlled trials, these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine.
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Seven studies were funded by Eli Lilly and Company, and one study was sponsored by McNeil Consumer and Specialty Pharmaceuticals.
“Seven studies were funded by Eli Lilly and Company manufacturers of atomoxetine and one study was sponsored by McNeil Consumer and Specialty Pharmaceuticals [19].”
When data on standard deviations were missing, study authors were contacted or data were calculated using standard error of subgroups or confidence intervals.
“When data on standard deviations were missing, study authors were contacted to provide missing data [18] or it was calculated using the standard error of subgroups or confidence intervals [19-21].”
The trial with the largest number of participants was of short duration of three weeks.
“The trial with the largest number of participants was of short duration of three weeks [19].”
Nine randomized trials comparing methylphenidate and atomoxetine in ADHD children and adolescents were included, with a total of 2762 participants.
“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
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- Authors
- Kemner, J. E., Starr, H. L., Ciccone, P. E., Hooper-Wood, C. G., & Crockett, R. S.
- ORCID
- Starr, H. Lynn
- Venue
- Advances in Therapy
- Published
- 2005-09
- Volume
- 22
- Issue
- 5
- Pages
- 498-512
- ISSN
- 0741-238X (ISSN-L)
- 1865-8652
- OpenAlex
- W1973632776
- Cited by
- 99
- References
- 22
- Citations by year
- 2025: 2 · 2023: 6 · 2022: 2 · 2021: 3 · 2020: 1 · 2019: 2 · 2018: 3 · 2017: 5 · 2016: 7 · 2015: 5 · 2014: 7 · 2013: 4 · 2012: 4
- FWCI
- 3.81
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Advances in Therapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- attention deficit hyperactivity disorder, OROS methylphenidate, atomoxetine, children, ADHD symptom improvement, treatment response, ADHD Rating Scale, adverse events, community-based treatment
- MeSH terms
- Atomoxetine Hydrochloride, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Female, Humans, Male, Methylphenidate, Propylamines, Prospective Studies, Treatment Outcome
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