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Once-Daily Atomoxetine Achieves Continuous Symptom Relief in Attention Deficit/Hyperactivity Disorder: Presented at APA

By Bruce Sylvester

SAN FRANCISCO, CA -- May 25, 2003 -- Once-daily atomoxetine offers safe, rapid, and continuous symptom relief to children with attention deficit/hyperactivity disorder (ADHD).

The efficacy of once-daily atomoxetine lasts throughout the day, into the evening and early morning, researchers reported here on May 23^rd at the 156^th Annual Meeting of the American Psychiatric Association.

"We saw higher efficacy earlier in the child's day when they need it most, and also lasting through the evening and sleeping hours, without a big drop-off effect prior to the next dosing," said investigator and presenter Douglas Kelsey, MD, PhD, clinical researcher, department of neuroscience, Eli Lilly and Co., Indianapolis, Indiana, United States. "In particular, the onset of symptom relief when it is generally most needed -- the first part of the day and school day -- suggests a distinctive role for this formulation in helping children be well and more successful."

A group of 197 children, aged 6-12 years and diagnosed with ADHD, were randomized in a 2:1 ratio to 8 weeks of once-daily atomoxetine or placebo.

The researchers evaluated the efficacy of symptom treatment using parent- and investigator-rating scales. Parental assessments of children's evening and early morning home behaviors were gathered using the Daily Parent Rating of Evening and Morning Behavior-Revised (DPREMB-R) and the Conners' Global Index: Parent Evening Scale (CGI-PE).

Results showed that once-daily atomoxetine at a final mean daily dose of 1.3 mg/kg was significantly more effective than placebo in treating core symptoms. Efficacy outcomes into the evening hours in active treatment patients were superior to those of placebo-treated patients as assessed by the DPREMB-R and CGI-PE.

The DPREMB-R showed a significant reduction of symptoms in the morning, and an onset of effect that was significantly different from that of placebo after the first day on medication. Discontinuations due to adverse events were less than 5% for both groups.

"This is very good news for these children," Dr. Kelsey noted. "But imagine what this also means to a parent who can now help his or her child start strong and remain stable throughout the day, with only one moment in each day to think about taking medication."

This research was funded by Eli Lilly and Co.


[Study title: Once-Daily Atomoxetine in Childhood ADHD: Continuous Symptom Relief. Abstract NR716]

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