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Cited by 15Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesSchizophrenia research and treatment

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 adolescents?

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Berek, Michael, Kordon, Andreas, Hargarter, Ludger, Mattejat, Fritz, Slawik, Lara, Rettig, Klaus, Schäuble, Barbara·2011·Child and Adolescent Psychiatry and Mental Health
DOI 10.1186/1753-2000-5-26PMC PMC3162502
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Abstract

Background: To 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. Methods: Pooled 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. Results: 822 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. Conclusions: Clinically 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.

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  • In the 12-week pooled analyses, the largest changes reported by adolescents were improved school performance and decreased burden of disease.

    “In the 12 week pooled analyses, the largest changes reported by adolescents were improved school performance and decreased burden of disease (Berek et al. 2011).”

    From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Berek et al. 2011

    The Results section (Inventory for assessing health-related quality of life; page unavailable) reports improved school performance and a decreased ADHD-related burden at week 12; it identifies burden as the individual item with the largest mean improvement. It says school performance improved substantially, but does not establish that school performance was one of the largest changes specifically reported by adolescents. (LLM, conf=0.84)

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  • Pooled analyses from two published 12-week open-label trials of psychostimulant medications in children and adolescents and a 4-week trial in adults reported improved QOL after treatment.

    “Similarly, pooled analyses from two published 12 week open-label trials examining psychostimulant medications in children and adolescents (Berek et al. 2011) and a 4 week trial in adults (Brams et al. 2011) reported improved QOL after treatment.”

    From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Berek et al. 2011

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Research works printed but not linked: 3

  1. Conners CK Rating scales in attention-deficit/hyperactivity disorder: use in assessment and treatment monitoring J Clin Psychiatry 1998 59 suppl 7 24 30 9680050
  2. Mattejat F Jungmann J Meusers M Moik C Nölkel P Schaff C Scholz M Schmidt M-H Remschmidt H Das Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK) - Eine Pilotstudie Z Kinder Jugendpsychiatr Psycother 1998 26 174 182 9757529
  3. Mattejat F Remschmidt H Das Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK) [The inventory of life quality in children and adolescents (ILC)] 2006 Verlag Hans Huber, Bern 9757529

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Authors
Berek, M., Kordon, A., Hargarter, L., Mattejat, F., Slawik, L., Rettig, K., & Schäuble, B.
Affiliations
  • University of Lübeck (DE)
  • Janssen (Germany) (DE)
  • Universitätsklinikum Gießen und Marburg (DE)
Corresponding author
Schäuble, Barbara
ORCID
Venue
Child and Adolescent Psychiatry and Mental Health
Publisher
Springer Science and Business Media LLC
Published
2011-07-26
Volume
5
Issue
1
Pages
26-26
ISSN
1753-2000 (ISSN-L)
DOI
10.1186/1753-2000-5-26
PMC
PMC3162502
OpenAlex
W2107845557
Cited by
15
References
37
Citations by year
2022: 2 · 2021: 2 · 2018: 1 · 2017: 3 · 2014: 3 · 2013: 2 · 2012: 2
FWCI
1.54
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Child and Adolescent Psychiatry and Mental Health (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
Cilag
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
attention deficit hyperactivity disorder, OROS methylphenidate, health-related quality of life, treatment response, symptom improvement, functioning, academic performance, dose adjustment, Children's Global Assessment Scale, non-pharmacological treatment, stimulant medication, disease burden, safety and tolerability

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