Exploring the Impact of Once-Daily OROS® Methylphenidate (MPH) on Symptoms and Quality of Life in Children and Adolescents with ADHD Transitioning From Immediate-Release MPH

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 (R)) MPH. Methods: Prospective, noninterventional study including patients (aged 6-18 years) with a confirmed diagnosis of ADHD who transitioned from IR MPH to OROS (R) MPH based on medical needs. Patients were transitioned to OROS (R) 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 (R) 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 (R) 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 (R) MPH as at least "good" and were at least "satisfied" with OROS (R) 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 (R) 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 (R) MPH was generally safe and well tolerated.