Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in
1McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA. 19034, USA. hstarr@mccus.jnj.com
Insights
This study found OROS methylphenidate (MPH) and atomoxetine effective for treating ADHD in African-American children. OROS MPH showed greater improvement in ADHD symptoms compared to atomoxetine.
Area of Science:
- Pediatric Neurology
- Pharmacology
- Psychiatry
Background:
- Attention-Deficit/Hyperactivity Disorder (ADHD) affects children globally.
- Limited data exists on ADHD treatment efficacy in minority populations.
- The Formal Observation of Concerta versUs Strattera (FOCUS) study evaluated Concerta (OROS methylphenidate) and Strattera (atomoxetine).
Purpose of the Study:
- To assess the effectiveness and tolerability of OROS MPH versus atomoxetine in African-American children with ADHD.
- To address the lack of subgroup data for minority groups in ADHD treatment research.
Main Methods:
- Subgroup analysis of the FOCUS study.
- Randomized patients to OROS MPH (n=125) or atomoxetine (n=58).
- Evaluated ADHD symptom improvement and adverse events over three weeks.
Main Results:
- Both OROS MPH and atomoxetine demonstrated significant symptom improvement from baseline.
- OROS MPH yielded significantly greater improvements in overall ADHD symptoms, inattentiveness, and global functioning.
- Adverse event incidence was comparable between the two treatment groups.
Conclusions:
- OROS MPH and atomoxetine are effective and well-tolerated ADHD treatments for African-American children.
- OROS MPH demonstrated superior efficacy compared to atomoxetine in this population over three weeks.
- Further research is warranted to fully understand treatment responses in this demographic.
Abstract:
The Formal Observation of Concerta versUs Strattera (FOCUS) study was conducted to assess, in children with ADHD, treatment outcomes with Concerta [OROS methylphenidate (MPH)], a once-daily controlled-release medication, and Strattera, (atomoxetine), a selective noradrenaline reuptake inhibitor, Because of the lack of data in minority groups treated for ADHD, the present subgroup analysis was conducted to determine the effectiveness and tolerability of ADHD treatments in African-American patients who were randomized to OROS MPH (n=125) or atomoxetine (n=58) during the FOCUS study. At the end of the study, the mean dose of OROS MPH was 32.8 +/- 10.9 mg and that of atomoxetine was 1.1 +/- 0.4 mg/kg. The results demonstrated that both treatments were associated with significant improvements in ADHD symptoms from baseline; however, patients who received OROS MPH demonstrated significantly greater improvements in total ADHD symptoms, inattentiveness and global improvement. The incidence of adverse events was similar in both treatment groups. OROS MPH and atomoxetine are effective and tolerable in the treatment of African Americans with ADHD, and significantly greater treatment responses were observed in patients receiving OROS MPH compared with those receiving atomoxetine over three weeks. Additional studies are needed to evaluate treatment response in this population.
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