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


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.


METHODS
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 < or = 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.
Saylor
Keith
K
NeuroScience, Inc., Herndon, VA 20170, USA. ksaylor@neuroscience-inc.com
Williams
David W
DW
Schuh
Kory J
KJ
Wietecha
Linda
L
Greenbaum
Michael
M
D000293:Adolescent; D000294:Adolescent Behavior / Q000187:drug effects*; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D011437:Propylamines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D011788:Quality of Life; D012309:Risk-Taking; D012649:Self Concept
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride