Transition from immediate-release methylphenidate (IR-MPH) to extended-release methylphenidate (OROS®-MPH, Concerta®) in Children with ADHD is associated with an improvement in functioning and quality of life – Results from a naturalistic study

Objectives: To explore changes in daily functioning (C-GAS) and quality of life (ILC) in children (6–12) with ADHD treated with OROS®-MPH

Methods: Post hoc analysis. Open label non-interventional trial in adolescents (ADHD; ICD-10 criteria) treated with flexible dose OROS MPH for 3 months (42603-ATT-4001). Effectiveness parameter were IOWA Conners' parent rating scale, C-GAS, ILC adolescents and parents at baseline and endpoint, physician's and parents'rating of treatment.

Results: 469 children (ITT group, Ø age 9.3 years±1.8; 84.9% male) were included. 20.3% discontinued prematurely (e.g. adverse events (AE) 7.9%; insufficient effectiveness 7.5%). Mean OROS MPH increased from 28,1mg/day±11,2 to 32.0mg/day±12.8at last observation. C-GAS scores improved clinically relevant from 58.5±14.8 to 71.0±15.4 (p<0.001). IOWA Connors Symptoms Scale – Parent scores (adjusted) improved from 29.3±10.7 to 19.0±10.9 (p<0.001). Changes in quality of life in parents (ILC-parents, LQ0–28) and children were clinically relevant (p<0.001) and correlation between ILC-parents and ILC-children was significant (p<0.001). 70.4% of parents rated treatment effectiveness as at least good and 77.6% treatment tolerability as at least good. A total of 284 treatment emergent AEs were reported in 142 patients (30.3%). AEs listed ≥3% of patients were insomnia (8.7%), anorexia (4.9%), insufficient effectiveness of treatment (3.2%).

Conclusion: Treatment with OROS®-MPH in children was associated with a significant improvement in quality of life in patients with ADHD as well as their parents and a significant and clinically relevant improvement in overall functioning. Treatment overall was well tolerated.