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Long-Term Atomoxetine (Strattera) Appears Safe and Well-Tolerated in Children and Adolescents With Attention Deficit/Hyperactivity Disorder: Presented at AACAP

By Jerry Ingram

WASHINGTON, DC -- October 25, 2004 -- Atomoxetine (Strattera) appears to be safe for long-term treatment of attention deficit/hyperactivity disorder in children and adolescents, researchers said here on October 20^th at the American Academy of Child and Adolescent Psychiatry 51^st Annual Meeting.

"Atomoxetine is safe and well tolerated for most people who take it. This [study] looks at children and we found similar results," explained Mark Bangs, MD, Director of the Adult ADHD program, Lilly Research Laboratories, Indianapolis, Indiana. "We're very proud to have 3-year data for growth. What we see is that there might be a slight slowing of growth early on in treatment but then it gets back to normal rates after several months."

"In addition, some of the bothersome side effects that people have reported during the clinical trials are usually transient," Dr. Bangs added.

For this investigation Dr. Bangs and colleagues conducted an analysis of adverse events, vital signs, electrocardiography and laboratory data on 3262 children and adolescents between the ages of 6 and 17 years of age who were treated with atomoxetine. They examined developmental landmarks from an integrated database from all company-sponsored trials of atomoxetine which lasted 1 year or longer.

Researchers found that the mean modal dose for these patients was 1.4mg/kg/day with 6% of them ceasing treatment due to adverse events. However, most common adverse events disappeared during ongoing treatment.

Dr. Bangs noted that patients experienced slight weight loss during the first year relative to 'normative expectations', but patients tended to return to expected growth rates by 18 months of treatment. In addition, they found no significant adverse effects in terms of sexual development and intelligence scores measured by the Wechsler Intelligence Scale-III.

The researchers concluded that atomoxetine appears to be safe and well tolerated for long-term treatment of children and adolescents with ADHD.


[Presentation title: "Developmental Outcomes of Long-Term Atomoxetine Treatment in ADHD." Poster A2]

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