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Long-term Atomoxetine Keeps Attention Deficit Hyperactivity Symptoms at Bay: Presented at APA

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- May 23, 2003 -- The norepinephrine reuptake blocker atomoxetine prevents relapses of attention-deficit hyperactivity disorder (ADHD) symptoms when used long-term, according to findings from a multinational, 9-month, placebo-controlled study.

Investigator David Michelson, MD, from the department of neuroscience at Eli Lilly and Company, presented the results in a poster here May 21^st at the 2003 Annual Meeting of the American Psychiatric Association.

Nearly twice as many children taking placebo had relapses of ADHD symptoms compared with those taking the active drug. "So the drug continues to have a protective effect in long-term treatment," Dr. Michelson said.

The initial phase of the trial enrolled 604 patients aged 6 to 15 years diagnosed by Diagnostic and Statistical Manual - Revision IV criteria for ADHD and treated at 33 centers around the world. The target dose was 1.2 mg/kg/day. Patients whose symptoms abated after the initial phase, as assessed by ADHD Rating Scale (RS) scores, were randomized to continue taking atomoxetine or to receive placebo; 416 children participated in the extended phase.

Of the children randomized to placebo, 52.6% were at least 50% worse with regard to symptom severity, compared with 29.7% of children who continued therapy with the active drug (P<0.001).

Time to relapse, defined as an increase in ADHD RS of at least 50% and an increase of at least 2 on the Clinical Global Impression of Severity (CGI-S) score, was faster on placebo (Wilcoxon P<0.001).

To prevent nausea that can accompany atomoxetine use, children should take it with food, Dr. Michelson advised. Taking the drug at night for the first few days can offset sedative effects.

Adverse events were few on the long-term treatment, Dr. Michelson said, noting that those who have problems tolerating the drug would have dropped out of the initial phase.

A height loss of 0.4 cm was evident in the first year of treatment, he said. As with stimulants, the effect results from an initial slowing of growth, then the child continues to grow. "The prudent thing to do," Dr. Michelson said, is to follow children's growth to see if they remain relatively close to their percentile for height.

Eli Lilly and Company supported the study.


[Study title: Results From a Long- Term Trial of Atomoxetine in the Prevention of Relapse in ADHD. Abstract NR639]

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