P0282 - Treatment with OROS^®-Methylphenidate in adolescents is associated with an improvement in functioning and quality of life - A post-hoc analysis

Abstract

Objectives:

To explore changes in daily functioning (C-GAS) and quality of life (ILC) in adolescents (12-18 years) with ADHD treated with OROS^®-MPH and their parents.

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:

129 out of 598 patients were adolescents (Ø age 14.2 years; 84.5% male) and 88.4% completed the study. Treatment was discontinued due to adverse events (3.9%), insufficient effectiveness (4.6%), lost to follow up (3.1%). Mean dose of OROS MPH increased from 34.6 mg/day ± 13.4 at baseline to 39.2 mg/day ± 13.4 at endpoint. C-GAS improved from 60.2 ± 14.0 to 72 ± 14.4 (p<0.001). Mean sum score on ILC-adolescents improved from 18.7 ± 3.6 to 20.6 ± 3.7 (p<0.001) and ILC-parents increased from 16.7 ± 3.9 to 19.6 ± 3.8 (p<0.001). Effectivity and tolerability was rated as at least good by >80% of physicians. 80.6% of parents were at least satisfied with therapy. 46 treatment - emergent adverse events were reported in 30 patients. AEs listed overall in ≥2% of patients were insomnia (3.9%), infection (2.3%), headache (2.3%), and nervousness (2.3%).

Conclusion:

Transitioning onto OROS^®-MPH in adolescents was associated with a clinically relevant improvement of Qol and daily functioning. Treatment with OROS MPH was well tolerated.