Improved functionality, health related quality of life and decreased burden of disease in patients with ADHD treated with OROS® MPH: is treatment response different between children and adolescentsReportar como inadecuado




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Child and Adolescent Psychiatry and Mental Health

, 5:26

First Online: 26 July 2011Received: 06 May 2011Accepted: 26 July 2011

Abstract

BackgroundTo compare clinical and health-related quality of life HRQoL outcomes between children and adolescents with ADHD treated with OROS MPH, using data from two large similarly-designed multicenter, prospective, open-label, single-arm, non-interventional studies.

MethodsPooled analysis 42603ATT4037, 42603 - ATT - 4001 including patients 6 to 18 years with a confirmed diagnosis of ADHD. Patients were treated with OROS MPH for 12 weeks; ADHD symptoms, functioning, HRQoL, safety and tolerability parameters were assessed.

Results822 patients 583 children 6-12 years, 239 adolescents 13-18 years were included in the pooled analysis. Mean daily OROS MPH starting doses in the child and adolescent subgroups were 29.0 ± 11.7 and 37.6 ± 15.6 mg, respectively p < 0.001. At study end week 12, the overall mean daily dose was 35.5 ± 14.0 mg, with children and adolescents receiving 32.8 ± 12.7 and 42.0 ± 15.1 mg-day, respectively p < 0.001. Significant p < 0.0001: overall population, children, adolescents symptomatic, functional and HRQoL improvements were observed from baseline to study end using the Conners- Parents Rating Scale overall: 29.2 ± 10.7 baseline to 19.3 ± 11.3 endpoint, Children-s Global Assessment Scale overall: 58.5 ± 14.5 baseline to 69.6 ± 16.1 endpoint, and ILC-LQ0-28. At week 12, between-age group differences were seen in the individual ILC-LQ0-28 parameters: school performance p = 0.001 parents- assessment, p = 0.032 childrens- assessment, global QoL p = 0.012 parents- and interests and hobbies p = 0.023 childrens-. Treating physician-s planned continued use of OROS MPH in 76.9%, 86.0% and 79.3% of children, adolescents and the total population, respectively, at study end p = 0.029 between-age subgroups. 195 of 822 patients 23.7% experienced at least one treatment-emergent adverse event; most commonly reported AEs in the total group ≥4% were insomnia 7.2%, anorexia 4.3% and involuntary muscle contractions 4.1%. No clinically relevant changes in body weight or vital signs were observed.

ConclusionsClinically relevant differences between children and adolescents with ADHD are present. Adolescents appeared to have a lower health related quality of life and functioning compared to children at baseline, however, they were able to reach comparable ratings at endpoint for most items. Similarly, burden of disease decreased in patients and their carers. OROS MPH was generally safe and well tolerated.

Electronic supplementary materialThe online version of this article doi:10.1186-1753-2000-5-26 contains supplementary material, which is available to authorized users.

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Autor: Michael Berek - Andreas Kordon - Ludger Hargarter - Fritz Mattejat - Lara Slawik - Klaus Rettig - Barbara Schäuble

Fuente: https://link.springer.com/







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