Drug reduces core ADHD symptoms but significant clinical and functional impairment persists
TUESDAY, March 22 (HealthDay News) -- For 5- and 6-year-old children with attention-deficit/hyperactivity disorder (ADHD), atomoxetine is generally well tolerated and reduces core ADHD symptoms, but it fails to translate to overall clinical and functional improvement, according to a study published online March 21 in Pediatrics.
Christopher J. Kratochvil, M.D., of the University of Nebraska Medical Center in Omaha, and colleagues investigated the efficacy and side effect profile of atomoxetine for the treatment of ADHD in 5- and 6-year-old children. They conducted an eight-week, double-blind, placebo-controlled randomized trial in 101 children with ADHD. Changes were measured using the ADHD-IV Rating Scale (ADHD-RS), the Clinical Global Impression-Severity (CGI-S) scale, the Children's Global Assessment Scale, and the ADHD-specific Clinical Global Impression-Improvement (CGI-I) scale.
The researchers found that, although there were significant reductions in the parent and teacher ADHD-RS scores among those taking atomoxetine versus placebo, this benefit failed to carry over to the CGI-S and CGI-I scales, which measure overall clinical and functional improvement. At the end of the study, 62 percent of participants who received atomoxetine were moderately, markedly, or severely ill according to the CGI-S scale. Children taking atomoxetine were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation.
"Although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies, including Eli Lilly and Company, which provided the study drug.
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