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Atomoxetine Appears Safe and Effective for Treating Young Children with Attention Deficit Hyperactivity Disorder: Presented at AACAP

By Jerry Ingram

MIAMI BEACH, FL -- October 19, 2003 -- Atomoxetine appears to be effective and safe for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 6- and 7-year-old children, according to researchers.

Researchers presented the findings here on October 17^th at the 50^th Anniversary Meeting of the American Academy of Child and Adolescent Psychiatry.

"We found that a fairly significant number of children who had been in the clinical trials were 6 or 7 years of age [over 300]. When we looked at the open label studies, efficacy was very similar to what we had seen with the older children," said Christopher J. Kratochvil, MD, lead researcher, University of Nebraska Medical Center, Omaha, Nebraska, United States.

For this presentation, Dr. Kratochvil and his team conducted a secondary analysis of children and adolescents who had taken part in double blind and open-label clinical trials of atomoxetine, a selective norepinephrine reuptake inhibitor recently approved by the U.S. Food and Drug Administration. Of the 3,500 participants, researchers found that 323 were 6 and 7 years old (126 in double-blind studies and 197 in open-label trials).

Those in the placebo-controlled achieved statistically significantly better results on the Hyperactive/Impulsive subscale (P<0.001), Inattentive subscale (P=0.002) and ADHD Total of the ADHD Revision IV (ADHD-IV) Rating Scale (P<0.001), as well as the Clinical Global Impressions ADHD Severity (CGI-ADHD-S) rating scale (P=0.037).

Six- and 7-year olds receiving atomoxetine as part of the open-label trials experienced significant group change (P<0.001) on all three ADHD-IV scales and the CGI-ADHD-S scale. In addition, antomoxetine was well tolerated, with only 11 discontinuing use due to adverse events (three in the double-blind study and eight in the open label trials).

"In the double blind studies we saw a very nice response in both inattentive and hyperactive impulsive subtypes, the combined subtypes, and a very nice separation from the placebo groups," concluded Dr. Kratochvil.


[Study title: Atomoxetine in the Treatment of Young Children with ADHD. Abstract D21]

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