12-month efficacy and safety of OROS® MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH
The aim of this study was to evaluate long-term clinical treatment with OROS® methylphenidate (MPH) (Concerta®) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who had been previously treated with immediate release (IR) MPH.
Subjects aged 6–16 years (n=105) who were stable on IR MPH (10–60 mg/day) were switched to 18, 36 or 54mg OROS® MPH once daily for 21 days, depending on prestudy MPH dose. Subjects who benefited from OROS® MPH could continue in a 12-month extension period. ADHD symptoms and treatment response were assessed by parents/caregivers and investigators.
Out of 105 enrolled children, 101 completed the 21-day treatment phase. In all, 89 parents/caregivers (88.1%) wanted their child to continue with the study treatment into the extension phase, and 56 children (63 %) completed the 1-year trial. The parent/caregiver global assessment of satisfaction ranged from 49 to 69% during the extension phase, and 49 to 71% of investigators rated the treatment as adequate. Efficacy and satisfaction were found more commonly in patients in the older age group (10–16 years), those on a higher dose (36 mg or 54 mg) and with the predominantly inattentive ADHD subtype. OROS® MPH was well tolerated.
Children and adolescents can effectively and safely be switched from IR MPH to OROS® MPH with improved symptom control and compliance.