CLINICAL DATA: Six randomized, double blind, placebo-controlled clinical trials have demonstrated that
atomoxetine was more effective than placebo for the treatment of children and adolescents with
ADHD. All these trials have shown a consistent improvement in the
ADHD rating scale (
ADHD-RS) from baseline in the patients treated with
atomoxetine, compared with that of the placebo group. The improvement of
ADHD symptoms was confirmed by the other secondary efficacy measures (the Clinical Global Impression, CGI, the Conners
ADHD rating scale/parent, teacher). The duration of action of
atomoxetine on
ADHD symptoms extended throughout the waking hours, and the
drug effects persisted up to the next morning with a single morning dose. Significant improvements were also observed with
atomoxetine compared to placebo, in several aspects of the quality of life measurement (social and family functioning), and the child's self-esteem. In addition, in patients who responded favourably to initial treatment,
atomoxetine was shown to be superior to placebo in maintaining a long term-response, up to 18 months.
Atomoxetine was effective and safe, both in young children and adolescents with
ADHD. Preliminary data also support the potential efficacy of
atomoxetine in managing patients with
ADHD and comorbid conditions, such as
tic disorders, oppositional-defiant and
conduct disorders.
DISCUSSION: As of June 2004, over 3,000 children and adolescents have been enrolled in clinical trials of
atomoxetine, with about 1,200 of them treated for more than 1 year and about 400 of them treated for more than 2 years.
Atomoxetine was well tolerated in most individuals, the two more common adverse events reported were gastro-intestinal disorders and decreased appetite. These side effects were generally noted to be transient. No significant changes in weight and height gain was reported over the long-term follow-up. There was no evidence of symptoms rebound and no evidence of an acute discontinuation syndrome when discontinuing treatment. In addition, given the mechanism of action of
atomoxetine in the central nervous system, and lack of subjective, physiological and psychomotor effects reported in experimental conditions, it is unlikely that
atomoxetine would have abuse potential.
CONCLUSION: Results from clinical trials demonstrated that
atomoxetine is effective and well tolerated for the acute and long-term treatment of children and adolescents suffering from
ADHD.
Atomoxetine should be considered as a new interesting pharmacological option in the treatment of
ADHD in association with non pharmacological therapeutic interventions.