Neuropediatrics 2006; 37 - P21
DOI: 10.1055/s-2006-974032

Transition from immediate-release methylphenidate (IR-MPH) to extended-release methylphenidate (Oros®-MPH, Concerta®) is associated with an improvement in quality of life in patients with ADHD – results from an open label naturalistic study

B Schaeuble 1, F Mattejat 2, L Hargarter 1, M Gerwe 1, J Czekalla 1
  • 1Medical & Scientific Affairs, Janssen-Cilag, Neuss, Neuss, Germany
  • 2IVV-Institut für Verhaltenstherapie und Verhaltensmedizin, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie, Marburg, Germany

Objectives: To examine effectiveness, daily functioning and quality of life (QoL) of once daily extended release methylphenidate (OROS®-MPH) in children and adolescents with attention-deficit/hyperactivity-disorder (ADHD), who had been treated previously with IR-MPH under conditions of daily routine.

Methods: Interim analysis of an open-label, prospective, multicenter non-interventional study (42603-ATT-4001) in children and adolescents aged 6–18 years with diagnosed ADHD according to DSM-VI criteria. After transitioning onto OROS®-MPH patients were treated using flexible dosing for 3 months. Documented were changes in IOWA Conners parent rating scale, C-GAS, and inventory for the assessment of quality of life (ILK). Statistical analyses was based on the ITT population using LOCF and Wilcoxon-test for dependent samples.

Results: 296 patients (mean age 10.4±2.5 years; 85% male) were documented with 85% retention rate. Symptoms significantly reduced from 29±11 to 19±11 points at endpoint on the IOWA Conners parents rating scale (p<0.0001). QoL improved significantly from 17±4 to 20±4 points on the ILK parent rating scale (p<0.0001). Childrens' daily functioning ameliorated significantly by 12±14 points in C-GAS (p<0.0001). 19.3% of the patients had at least one adverse event (AE) and serious AEs unrelated to OROS®-MPH occurred in 2 patients. Most frequent AEs were insomnia (5.7%) and nervousness (2.7%). Quality of sleep and appetite remained unchanged after transitioning onto OROS®-MPH. Tolerability was rated as „good“ or „very good“ by 85% of the parents.

Conclusion: The transitioning onto OROS®-MPH was associated with a significant improvement in clinical symptoms, daily functioning and quality of life in patients with ADHD previously treated with IR-MPH. Treatment with OROS®-MPH was safe and well tolerated in this population.