Tolerability and effects of OROS® MPH (Concerta®) on functioning, severity of disease and quality of life in children and adolescents with ADHD: results from a prospective, non-interventional trial
Abstract
Attention-deficit/hyperactivity disorder may have substantial impact on family life, peer interactions, and quality of life. Stimulants are recommended as first-line pharmacotherapy for ADHD. OROS(®) MPH (Concerta(®)) is a long-acting preparation with duration of effect for up to 12 h. In this 8-week, prospective, open-label, non-interventional trial the impact of therapy with OROS(®) MPH on functioning in four different areas of life (school, recreation, family life, and peer interaction), severity of disease, and quality of life (QoL) as well as tolerability were investigated under daily routine care. 306 patients, aged 10.2±2.3 years, were either transitioned to OROS(®) MPH from short-acting, immediate-release MPH (-IR) preparations (n=231; 75%), or treatment was initiated with OROS(®) MPH in MPH-naïve patients (n =75; 25%). In both groups, therapy with OROS(®) MPH was associated with significant improvements in daily functioning, severity of disease, and QoL. Adverse events (AE) were documented in 160 patients (52.3%). In 95 patients (31.0%) a causal relationship was assessed as at least possible. Four serious AEs were reported in 2 patients and rated as doubtfully related to study medication. Most frequent AEs (≥5% of patients) were insomnia, anorexia, ineffectiveness of medication, and headache. In 12.1% of patients AE led to discontinuation of study participation. Considering the limitations of this non-interventional study, the results refer to the importance of a the…
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The broad improvements in participant-perceived QOL observed in this trial are in line with those previously described with psychostimulant and nonstimulant treatment in children, adolescents, and adults with ADHD.
“The broad improvements in participant-perceived QOL observed currently are in line with those described previously with psychostimulant and nonstimulant treatment in children, adolescents, and adults with ADHD (Spencer et al. 2008; Cannon et al. 2009; Gerwe et al. 2009; Brown and Landgraf 2010; Wehmeier et al. 2010; Berek et al. 2011; Brams 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 Gerwe et al. 2009
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Childress, A. C., Cutler, A. J., Saylor, K., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Findling, R. L. (2014) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2013.0077 · Cited by 5 · see citing works
- Authors
- Gerwe, M., Stollhoff, K., Mossakowski, J., Kuehle, H.-J., Goertz, U., Schaefer, C., Bogdanow, M., & Heger, S.
- Affiliations
- Johnson & Johnson (Germany) (DE)
- ClinAssess (Germany) (DE)
- Corresponding author
- Gerwe, Martin
- Venue
- ADHD Attention Deficit and Hyperactivity Disorders
- Published
- 2009-08-06
- Volume
- 1
- Issue
- 2
- Pages
- 175-186
- ISSN
- 1866-6116 (ISSN-L)
- 1866-6647
- OpenAlex
- W2063445955
- Cited by
- 7
- References
- 5
- Citations by year
- 2018: 1 · 2016: 1 · 2015: 2 · 2014: 3
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- ADHD Attention Deficit and Hyperactivity Disorders (publishedVersion)
- PubMed (publishedVersion)
- 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 › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- attention deficit hyperactivity disorder, OROS methylphenidate, Concerta, long-acting stimulants, quality of life, daily functioning, disease severity, tolerability, adverse events, children and adolescents, peer interaction, academic performance
- MeSH terms
- Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Family, Female, Humans, Male, Methylphenidate, Peer Group, Quality of Life, Social Behavior
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