Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized
Jason E Kemner1, H Lynn Starr, Patrick E Ciccone
1McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, Pennsylvania 19034, USA.
Insights
This study found OROS methylphenidate (MPH) provided greater symptom improvement for children with attention-deficit/hyperactivity disorder (ADHD) compared to atomoxetine. Both treatments were well-tolerated, with similar withdrawal rates due to adverse events.
Area of Science:
- Pediatric Psychiatry
- Neuroscience
- Pharmacology
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Effective pharmacological management is crucial for improving core ADHD symptoms and daily functioning.
- Comparative effectiveness studies in real-world settings are needed to guide clinical decision-making.
Purpose of the Study:
- To compare the treatment outcomes of OROS methylphenidate (MPH) and atomoxetine in children with ADHD.
- To evaluate physician and parent assessments of symptom improvement in a community-based setting.
- To assess the safety and tolerability of both medications.
Main Methods:
- A multicenter, prospective, open-label study randomized 1323 children (6-12 years) with ADHD to OROS MPH or atomoxetine for 3 weeks.
- Investigator-rated measures included the ADHD Rating Scale (ADHD-RS) and Clinical Global Impression-Improvement (CGI-I).
- Assessments were conducted at baseline and at weeks 1, 2, and 3.
Main Results:
- Both OROS MPH and atomoxetine significantly reduced ADHD symptoms from baseline (P < .001).
- OROS MPH demonstrated significantly greater mean reductions in ADHD-RS scores compared to atomoxetine (20.24 vs. 16, P < .001).
- Treatment response rates were significantly higher with OROS MPH at all evaluation points (P < .001), with similar adverse event-related withdrawal rates (4.8% vs. 5.5%).
Conclusions:
- OROS methylphenidate showed superior efficacy in improving ADHD symptoms compared to atomoxetine in this community-based study.
- Both medications were generally well-tolerated, suggesting they are viable treatment options for pediatric ADHD.
- The findings support OROS MPH as a potentially more effective option for symptom management in children with ADHD in a clinical practice setting.
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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