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Atomoxetine Safe and Effective in Long-term, Open-label Treatment of Adults With ADHD: Presented at APA

By Bruce Sylvester

SAN FRANCISCO, CA -- May 23, 2003 -- Results of an interim analysis of data from an ongoing trial suggest that long-term atomoxetine treatment is effective and safe in adults with ADHD, researchers report.

The study was presented here May 22^nd at the 2003 Annual Meeting of the American Psychiatric Association.

"We have lots of short-term data on the efficacy, safety, and tolerability of this drug for ADHD in adults, but this study really begins to distinguish atomoxetine as something that can be used for the long haul for adults," said investigator and co-presenter Dean Jones, PhD, senior scientific investigator at Lilly Research in Indianapolis, Indiana, United States.

"This open-label follow-up study follows up on acute treatment studies and takes us to the next step in establishing the efficacy, safety, and tolerability of atomoxetine beyond the acute phase," added lead researcher and presenter Thomas Spencer, MD, associate professor of psychiatry at Harvard University Medical School in Boston, Massachusetts.

The investigators recruited 384 subjects from 2 acute placebo-controlled studies for this open-label extension study.

The subjects received a mean dose of 94.3 mg/day atomoxetine in the 10-week acute, placebo-controlled studies. Then they went through a wash-out of up to 4 weeks before being treated with atomoxetine 60-120 mg/day (mean dose 96.5 mg/day for an average of 34 weeks) in this ensuing open-label study.

The researchers used the Conners Adult ADHD Rating Scales: Investigator (CAARS:Inv) as the primary measure of efficacy. "Total ADHD symptom scores decreased from a mean 34.5 at baseline by 15.0 (43.5%). Two thirds of patients achieved at least a 30% decrease in CAARS scores," they reported. "Clinical Global Impression of Severity scores (CGI-S) decreased from 4.7 at baseline by 1.4 (29.8%); 80% achieved at least a 1-point decrease and 47% achieved at least a 2-point decrease in CGI-S scores," they added.

The atomoxetine drop-out rate for adverse events was 8.5% in the acute studies and 7.8% in the open-label study. Atomoxetine was also generally well tolerated, the authors noted.

The study was supported by Eli Lilly and Company.


[Study title: Efficacy and Safety of Atomoxetine in Long-Term, Open-Label Treatment of Adults With ADHD. Abstract NR645]

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