SAN DIEGO – Atomoxetine appears to be safe in children and adolescents who have attention-deficit hyperactivity disorder and comorbid Tourette's syndrome, Dr. Thomas J. Spencer reported during a poster session at the annual meeting of the American Academy of Child and Adolescent Psychiatry.
“My clinical sense is that's a great drug for the combination,” said Dr. Spencer, a child and adolescent psychiatrist who is assistant director of the pediatric psychopharmacology unit at Massachusetts General Hospital, Boston. “That being said, if kids have really bad tics, you use neuroleptics, pretty powerful drugs. But tics often fluctuate. So if the tics are mild or moderate, or if they drift into that range,” atomoxetine is an option.
As part of a larger study of children with ADHD and comorbid tic disorders, Dr. Spencer and his associates conducted a subanalysis of 117 children with ADHD and Tourette's syndrome (Neurology 2006;65:1941–9). The mean age of the children was 11 years, and most (87%) were boys.
The children were randomized to double-blind treatment with placebo or 0.5–1.5 mg/kg per day of atomoxetine (Strattera) for about 18 weeks. There were 56 children in the placebo group and 61 in the treatment group.
According to results of the Yale Global Tic Severity Scale and the Clinical Global Impressions severity of tic/neurologic symptoms score, children who received atomoxetine had a significantly greater reduction in tic severity between baseline and end of treatment, compared with the placebo group. However, results of the Tic Symptom Self-Report total score revealed that atomoxetine treatment did not significantly reduce tic severity, compared with children in the placebo group.
Children who received atomoxetine achieved significantly better ADHD Rating Scale total and subscale scores and Clinical Global Impressions overall severity scores, compared with their counterparts in the placebo group. However, the researchers wrote in the poster that atomoxetine treatment was “associated with increased pulse rate, decreased body weight, and significantly higher rates of decreased appetite and nausea. No other clinically relevant treatment differences were seen in any other vital sign, adverse event, laboratory parameter, or electrocardiographic measure.”
The study was funded by Lilly Research Laboratories. Dr. Spencer disclosed that he is an adviser and speaker for Eli Lilly & Co. He has also received research support from the company.
Atomoxetine is approved by the FDA for treatment of ADHD in children, adolescents, and adults.