Effects of atomoxetine on self-reported high-risk behaviors and health-related quality of life in adolescents with ADHD

Abstract

Objective:

This study measured the effects of atomoxetine HCl on high-risk behaviors and health-related quality of life in adolescents with attention-deficit/hyperactivity disorder (ADHD), using a subgroup analysis of data from a previous clinical trial.

Research design and methods:

In the base study, which was conducted at 26 sites in the United States, patients ages 13–16 years were randomized in a double-blind manner to atomoxetine treatment by one of two dose titration schedules for 8 weeks. Patients who responded to treatment were rerandomized to atomoxetine at a daily dose of 0.8 or 1.4 mg/kg for 40 weeks. Patients in the highest-risk quartile for each category of behavior or domain were included and the dosing groups combined.

Main outcome measures:

Efficacy measures included the Youth Risk Behavior Surveillance (YRBS) and Child Health and Illness Profile – Adolescent Edition (CHIP-AE). The YRBS has six categories of behavior, and the CHIP-AE has six domains. Data for mean change from baseline were analyzed using a last-observation-carried-forward analysis.

Results:

A total of 267 patients were randomized, but the high-risk subgroup analyzed in the present study was much smaller (range of n = 5–68 per group). YRBS scores for tobacco use, unhealthful dietary behaviors, inadequate physical activity, and behaviors contributing to unintentional injuries showed statistically significant improvements (p < 0.05) by atomoxetine treatment at Week 8. At the end of the 40-week maintenance period, unhealthful dietary behaviors, inadequate physical activity, and behaviors contributing to unintentional injuries continued to show statistically significant improvements (p < 0.001). When the highest-risk quartile of the CHIP-AE data was analyzed, there were statistically significant improvements on all six domains after atomoxetine treatment at 8 weeks (p < 0.001) and on five of the six domains at 40 weeks (p ≤ 0.01).

Conclusions:

Atomoxetine improved self-reported high-risk behaviors and overall health-related quality of life in adolescents with ADHD. Potential limitations of this study include small sample sizes and the fact that it involved a subgroup analysis, which is by nature hypothesis-generating. Further, well-controlled, prospective studies in larger and more heterogeneous ADHD populations, including older patients, are warranted to confirm or reject these findings.

Key words::

• Adolescents
• Atomoxetine
• Attention-deficit/hyperactivity disorder
• Behavior
• Quality of life
• Risk

Transparency

Declaration of funding

This study was supported by Lilly USA, LLC (Indianapolis, IN, USA), which had a role in study design, data acquisition and interpretation, and the decision to publish the findings.

Declaration of financial relationships

L.W., D.W.W. and K.J.S. have disclosed that they are employees of, and minor shareholders in, Lilly, the study sponsor. K.S. has disclosed that he has served as a consultant/speaker for, and/or has received research funding from, Lilly and Bristol-Myers Squibb, Johnson & Johnson, McNeil, Merck, New River, Otsuka, Pfizer, Shire, Supernus, PGx Health, Psychogenics and sanofi-aventis. M.G. has disclosed that he has served as a consultant/speaker for, and/or has received research funding from, Abbott, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Lilly, Novartis, Pfizer, sanofi-aventis, Shire and Takeda.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has received research funding from, and sits on a speakers bureau for Eli Lilly; and had acted as an advisor to Shire, Eli Lilly and UCB. Peer Reviewer 2 has no relevant financial relationships.

Acknowledgments

Assistance in manuscript preparation was provided by Leslie M. Schuh, PhD, and Stephen W. Gutkin, Rete Biomedical Communications Corp., Wyckoff, NJ, USA, with support from the study sponsor.

Author contributions: K.S. and L.W. were involved in the study conception and design. K.S. and M.G. were involved in data acquisition. All authors analyzed and interpreted the data. K.S. drafted the manuscript with editorial assistance from Leslie M. Schuh, PhD, and Stephen W. Gutkin. All authors revised and edited the manuscript for intellectual content and approved the content of the final completed manuscript.