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Cited by 30Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesMedication Adherence and Compliance

HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system

Manos, Michael, Frazier, Thomas W., Landgraf, Jeanne M., Weiss, Margaret, Hodgkins, Paul·2009·Current Medical Research and Opinion
DOI 10.1185/03007990903388797
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Abstract

OBJECTIVE: To evaluate the impact of methylphenidate transdermal system (MTS) on health-related quality of life (HRQL) and medication satisfaction in children with attention-deficit/hyperactivity disorder (ADHD) as well as to identify potential moderators of HRQL and medication satisfaction. RESEARCH DESIGN AND METHODS: Children aged 6-12 years diagnosed with ADHD were enrolled (N = 128) and 115 children completed the study. MTS dose was optimized over 5 weeks using 10-, 15-, 20-, or 30-mg patches worn for 9 hours. The efficacy of 4- and 6-hour wear times was then assessed in an analog classroom setting in a randomized, placebo-controlled, double-blind, three-way crossover design study. MAIN OUTCOME MEASURES: The ADHD Impact Module-Children (AIM-C), a validated HRQL instrument, was used to assess the impact of ADHD symptoms on children and their families. Satisfaction with MTS use was assessed via a Medication Satisfaction Survey (MSS). A parent or legally appointed representative (LAR) completed the measures. Tolerability was monitored by spontaneous adverse event reporting. RESULTS: Mean scores on AIM-C child and family HRQL scales improved from baseline to endpoint across all MTS doses and the magnitude of improvement increased with time from baseline. Improvement was noted for behavior, missed doses, worry, and economic impact AIM-C scores. Overall, parents/LARs indicated a high level of satisfaction with their child's use of MTS (Visit 7 [92.1%]; Visit 10 [89.1%]). Most treatment-emergent adverse events (TEAEs) were mild to moderate. The most frequent TEAEs included decreased appetite (28%), headache (21%), insomnia (20%), and abdominal pain (12%). CONCLUSIONS: At study endpoint, MTS treatment of ADHD was associated with robust improvement in child and family HRQL, key economic impact items, and overall medication satisfaction with the effectiveness and ease of use of MTS as an ADHD treatment. Also, the majority of MTS TEAEs were mild to moderate in severity. Limitations of this study included the potential for a significant halo effect when measuring HRQL and medication satisfaction as well as the uncertainty regarding whether the improvements seen over this relatively short study duration would be sustainable long term. CLINICAL TRIAL REGISTRATION: #NCT00151970.

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  • Transdermal methylphenidate in short-term studies is associated with efficacy throughout the day, improved family quality of life, and little effect on sleep when carefully titrated.

    “Transdermal methylphenidate bypasses the oral route entirely, and in short-term studies is associated with efficacy throughout the day, with improved family quality of life, and when carefully titrated, little effect on sleep [44-46].”

    From Advances in understanding and treating ADHD (2011) · cites this paper as [46]

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Authors
Manos, M., Frazier, T. W., Landgraf, J. M., Weiss, M., & Hodgkins, P.
Affiliations
  • Cleveland Clinic (US)
  • HealthActCHQ Inc., Cambridge, MA, USA
  • University of British Columbia (CA)
  • Shire Development Inc., Wayne, PA, USA
Corresponding author
Manos, Michael
ORCID
Venue
Current Medical Research and Opinion
Publisher
Informa Healthcare
Published
2009-10-23
Volume
25
Issue
12
Pages
3001-3010
ISSN
  • 0300-7995 (ISSN-L)
  • 1473-4877
DOI
10.1185/03007990903388797
OpenAlex
W2021208922
Cited by
30
References
34
Citations by year
2025: 1 · 2024: 4 · 2023: 1 · 2021: 1 · 2018: 1 · 2017: 2 · 2016: 1 · 2015: 2 · 2014: 2 · 2013: 1 · 2012: 2
FWCI
2.89
Type
journal article
Language
en
Open access
closed
Locations
  • Current Medical Research and Opinion (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 › Family Practice › Medication Adherence and Compliance
Keywords
attention deficit hyperactivity disorder, children, health-related quality of life, medication satisfaction, treatment-emergent adverse events, drug tolerability
MeSH terms
Administration, Cutaneous, Algorithms, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Double-Blind Method, Female, Health, Humans, Male, Methylphenidate, Placebos, Quality of Life, Treatment Outcome, Patient Satisfaction, Cross-Over Studies

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