Transitioning to OROS^® methylphenidate from atomoxetine is effective in children and adolescents with ADHD

Abstract

Objective: To explore the clinical outcomes of children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from atomoxetine to OROS^® methylphenidate (MPH). Methods: This prospective, noninterventional study involved patients aged 6–18 years with a confirmed diagnosis of ADHD who experienced insufficient clinical response and/or poor tolerability during atomoxetine treatment. Patients were transitioned to OROS MPH and followed for 12 weeks. ADHD symptoms, functional outcomes, health-related quality of life (HRQoL) and tolerability were assessed throughout the study. Results: 42 patients (intention-to-treat) transitioned from atomoxetine 43.2 plus 14.7 mg onto OROS MPH 33.0 plus 17.7 mg (mean daily starting dose), increasing to 38.6 plus 17.6 mg at the final visit. Median treatment duration was 85 days (range: 3–155). Compared with baseline, symptoms, functional outcome and HRQoL improved after transitioning to OROS MPH as assessed by the Conners’ Parent Rating Scale (mean change from baseline: -10.1 ± 11.6; p < 0.0001), Children’s Global Assessment Scale (8.7 ± 16.2; p = 0.0015) and ILC-LQ0–28 scores (parents’ rating from 14.9 ± 3.6 [baseline] to 17.5 ± 4.8 [study end]; p = 0.0002; patients’ rating from 16.9 ± 3.9 [baseline] to 19.3 ± 4.4 [study end]; p = 0.0003). Social interactions and late afternoon tasks (playing with other children, household chores, school homework and behavior towards visitors/at visits) improved (p < 0.001). Approximately 62% expressed satisfaction (‘very good’ or `good’) with OROS MPH therapy compared with prior atomoxetine with respect to symptom control in the late afternoon. The most common treatment-emergent adverse events after switching were involuntary muscle contractions (tics; 16.7%), insomnia (14.3%), abdominal pain (9.5%) and headache (9.5%). No clinically relevant changes in body weight or vital signs were observed. Conclusion: In this naturalistic setting, transitioning from atomoxetine to OROS MPH was associated with improved ADHD symptoms and impacted positively on patients’ and parents’ HRQoL and disease burden in ADHD children who demonstrated an insufficient response and/or poor tolerability to atomoxetine.

Keywords::

• ADHD
• children/adolescents
• OROS methylphenidate
• transition

Acknowledgements

The authors thank Professor Dr Phil. Fritz Mattejat for discussions centered on health-related quality of life aspects measured by Inventory for Assessment of Quality of Life in Children and Adolescents, and for the provision of healthy control data, and also thank all patients, caregivers and investigators for study participation.

Financial & competing interests disclosure

The study was funded by Janssen-Cilag GmbH, Neuss, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors thank David Figgitt PhD, on behalf of Content Ed Net, for editorial assistance in the preparation of this manuscript; this editorial assistance was funded by Janssen-Cilag GmbH.