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

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.

Key words::

• AIM-C
• Attention-deficit/hyperactivity disorder
• Medication satisfaction
• Methylphenidate transdermal system
• Quality of life
• Stimulants

Transparency

Declaration of funding

This study, in which M.M. was an investigator, was funded by Shire Development Inc.

Declaration of financial/other relationships

M.M. has disclosed that he has received grant support from Shire US and McNeil Consumer and Specialty Pharmaceuticals; has served as a consultant/advisor to Eli Lilly; and has participated in speakers bureaus for Shire US and Veritas Institute for Medical Education. T.W.F. has disclosed that he has served as a consultant/advisor and a statistical consultant for secondary data analysis to Shire Development, Inc. J.M.L. has disclosed that she is Vice President and Chief Scientific Officer with HealthActCHQ, which owns the intellectual property rights to the AIM-C survey. M.W. has disclosed that she has received funds for investigator-initiated trials from Eli Lilly, Shire, Purdue, and Janssen; has served as a consultant/advisor to Shire, Novartis, Eli Lilly, Janssen, Purdue, Takeda, Abbott, and Johnson & Johnson; has served on speakers bureaus for Abbott, Eli Lilly, Shire, Novartis, Janssen, Purdue, Takeda; and has received royalties from Checkmate Plus and The Johns Hopkins Press. P.H. has disclosed that he is a full-time employee of Shire Pharmaceuticals and is a shareholder in the company.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors thank the parents and children who participated in the study and acknowledge Laura Miesle, PharmD, of The JB Ashtin Group Inc., for assistance in the preparation of this manuscript based on an author approved outline and for implementing author suggested revisions. This assistance was funded by Shire Development, Inc.

Notes

* Daytrana is a registered trade name of Shire Pharmaceuticals Ireland Ltd, Dublin, Ireland.

† DSM-IV-TR is a registered trademark of American Psychiatric Publishing, Inc., Arlington, VA, USA.