12-month efficacy and safety of OROS® MPH in children and adolescents with attention deficit/hyperactivity disorder switched from MPH

Hoare, P., Remschmidt, H., Medori, R., Ettrich, C., Rothenberger, A., Santosh, P., Schmidt, M., Spender, Q., Tamhne, R., Thompson, M., Tinline, C. and Trott, G.E. (2005) 12-month efficacy and safety of OROS® MPH in children and adolescents with attention deficit/hyperactivity disorder switched from MPH. European Child & Adolescent Psychiatry, 14 (6), 305-309. (doi:10.1007/s00787-005-0486-3).

Abstract

PURPOSE: 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.

METHODS: Subjects aged 6-16 years (n=105) who were stable on IR MPH (10-60 mg/day) were switched to 18, 36 or 54 mg 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.

RESULTS: 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.

CONCLUSIONS: Children and adolescents can effectively and safely be switched from IR MPH to OROS MPH with improved symptom control and compliance.

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