P0321 - Changes in quality of life in ADHD-patients treated with extended-release Methylphenidate (OROS^®-MPH) - results from an open-label naturalistic study

Abstract

Objectives:

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

Methods:

Full analysis. Open label non-interventional trial in children & adolescents with ADHD (ICD-10 criteria) treated with flexible dose OROS MPH for 3 months (42603-ATT-4001). Effectiveness parameter were C-GAS, ILC adolescents and parents and IOWA Conners' parent rating scale at baseline and endpoint.

Results:

598 patients with ADHD (ICD-10 criteria; Ø age 10.4 years ± 2.6; 84.8% male) were documented. 81.6% completed the observation. Mean OROS MPH dose at last observation was 33.5 mg/day (SD ± 13.3). Patients improved on C-GAS from 58.9±14.7 to 71.2±15.1 (p<0.001). IOWA Connors Symptoms decreased from 29.0 ± 10.5 to 18.5 ± 10.6 (p<0.0001). ILC improved from 18.8 ± 4.0 to 20.8±3.8 in children and adolescents (p<0.0001) and from 17.2±3.9 to 19.7±3.9 in parents (p<0.001). At endpoint, 76.8% of patients showed at least minimal improvement on CGI-C. Adverse events were reported in 28.8% of patients. AEs listed in ≥2% of patients were insomnia (7.7%), anorexia (3.9%), ineffectiveness (2.8%), headache (2.3%), nervousness (2.2%) and involuntary muscle contractions (2.2%). There were no significant changes in blood pressure or pulse.

Conclusion:

Treatment with OROS®-MPH was associated with a clinically relevant improvement in daily functioning in patients with ADHD and Qol improved significantly in patients and their parents. Treatment with OROS®-MPH was well tolerated.