Comparison of the efficacy of two different modified release methylphenidate preparations for children and adolescents with attention-deficit/hyperactivity disorder in a natural setting: comparison of the efficacy of Medikinet(®) retard and Concerta(®)--a randomized, controlled, double-blind multicenter clinical crossover trial.

Autor:	Döpfner M; Department of Child and Adolescent Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany. manfred.doepfner@t-online.de, Ose C, Fischer R, Ammer R, Scherag A
Jazyk:	angličtina
Zdroj:	Journal of child and adolescent psychopharmacology [J Child Adolesc Psychopharmacol] 2011 Oct; Vol. 21 (5), pp. 445-54. Date of Electronic Publication: 2011 Jul 26.
DOI:	10.1089/cap.2010.0082
Abstrakt:	Objective: The comparison of the efficacy of Medikinet(®) retard and Concerta(®) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years). The duration of the study per patient was 3 weeks. Methods: The primary outcome variable was the German version of the "Swanson, Kotkin, Agler, M-Flynn, and Pelham scale" in the first 3 hours of school as assessed by teachers. Results: Medikinet retard with a higher IR component than Concerta (and an equivalent daily dose) was superior to Concerta (p=0.0009), and Medikinet retard with similar IR components in the morning as Concerta (but a lower daily dose) was noninferior to Concerta with regard to the primary outcome. Further, exploratory analyses on teacher and parent ratings on attention-deficit/hyperactivity disorder and on externalizing symptoms during the day revealed no evidence for the superiority of Concerta over Medikinet retard in an equivalent daily dosage throughout the day. Conclusion: Children and adolescents may be treated with a lower daily dose of Medikinet retard (which has a similar IR component as Concerta) without resulting in a clinically relevant worse effect during school time.
Databáze:	MEDLINE
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