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Acute Treatment with Atomoxetine Equally Effective in Children and Adolescents: Presented at AACAP
By Paula Moyer
TORONTO, CANADA -- November 14, 2005 -- Acute treatment of attention deficit hyperactivity disorder (ADHD) with atomoxetine (Strattera) is as effective and well tolerated in children as it is in adolescents, according to a study presented at the joint annual meeting of the American and Canadian Academies of Child and Adolescent Psychiatry (AACAP/CACAP).
"Atomoxetine is efficacious for the acute treatment of ADHD in children and adolescents," said principal investigator Timothy E. Wilens, MD. "Robustness and time to response of ADHD symptoms were similar between age groups."
Dr. Wilens is the director of substance abuse services in pediatric pharmacology at Massachusetts General Hospital, and Professor of Psychiatry, Harvard Medical School Boston, Massachusetts, United States.
The researchers conducted the study to resolve the controversy regarding the tolerability and response to certain ADHD medications across the life span. They conducted a meta-analysis of six double-blind, placebo-controlled studies in which patients received atomoxetine or placebo once or twice daily for 6 to 9 weeks.
The analysis involved 851 patients <12 years old and 176 who were 12 years old or older. The efficacy measures included the ADHD Rating Scale (ADHD RS), the Clinical Global Impression-Severity (CGI-S) scores, the Conners Parent Rating Scale-ADHD (CPRS-ADHD), response rates, and times to response. Response was defined as a decrease of at least 25% on the ADHD RS score.
Scores on the CPRS-ADHD decreased an average of 8.41 points in treated children and 8.31 points in treated adolescents, compared to an average decrease of 2.45 points and 1.62 points in the respectively placebo groups.
Similarly, scores on the ADHD RS, which were lower at baseline in adolescents, decreased similarly in both age groups compared to placebo (P < .001). CGI-S scores also decreased an average of 1.4 points in each group.
Response rates were 59.3% in treated children and 61.1% in treated adolescents, compared to 30.9% and 35.4% of placebo subjects, respectively. The time to response was approximately 5 days for treated subjects in each age group.
The investigators found no significant differences between the age groups regarding overall rates of adverse events, vital signs, laboratory values, changes in height or weight, and electrocardiogram.
Although the rates of headache were similar between the groups (20.9% in children and 20.8% in adolescents), children were more likely to report treatment-emergent headaches.
"The analysis of adverse events by age did not suggest clinically meaningful differences in tolerability between adolescents and children," Dr. Wilens said.
The study was funded by Eli Lilly and Company, which manufactures Strattera.
[Presentation title: Acute Effects of Atomoxetine in Children versus Adolescents. Abstract C45]
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