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Abstract
Objectives: To explore the clinical and health-related quality of life (HRQoL) outcomes in children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from immediate-release (IR) methylphenidate (MPH) and were initiated on Osmotic Release Oral System (OROS®) MPH. Methods: Prospective, noninterventional study including patients (aged 6–18 years) with a confirmed diagnosis of ADHD who transitioned from IR MPH to OROS® MPH based on medical needs. Patients were transitioned to OROS® MPH and were followed for 12 weeks. Attention-deficit/hyperactivity disorder symptoms, functional outcomes, HRQoL, and tolerability were assessed throughout the study. Results: 598 patients entered the intention-to-treat analysis. The mean OROS® MPH starting dose was 29.5 ± 12.0 mg/day, increasing slightly to 33.5 ± 13.2 mg/day at final visit. Compared with baseline, there were significant (all P < 0.0001) symptomatic, functional, and HRQoL improvements after transitioning from IR MPH to OROS® MPH as assessed by the Conners' Parent Rating Scale (from 29.0 ± 10.5 to 19.5 ± 11.1), Children's Global Assessment Scale (by 11.0 ± 13.3), and Inventory for Assessing Quality of Life (ILC) LQ0–28 scores (parents' rating from 17.2 ± 3.9 to 19.4 ± 4.0; patients' rating from 18.7 ± 4.0 to 20.5 ± 3.9). Overall, no significant changes in quality of sleep or appetite were observed. More than 70% of parents and physicians rated the effectiveness of OROS® MPH as at least “good” and were at least “satisfied” with OROS® MPH. The most common treatment-emergent adverse events were insomnia and anorexia. No clinically relevant changes in body weight or vital signs were observed. Conclusions: In this naturalistic setting, transitioning from IR MPH to OROS® MPH, in patients who showed previously insufficient response and/or poor tolerability, was successful. Patients' and parents' HRQoL as well as burden of disease showed a clinically relevant improvement. OROS® MPH was generally safe and well tolerated.