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(January 16, 2004) -- Abrupt discontinuation of atomoxetine (Strattera) is not associated with symptom rebound nor increases in adverse events in patients with attention deficit/hyperactivity disorder (ADHD), according to a new study.
Methylphenidate (Ritalin), amphetamine (Adderall), and D-amphetamine (Dexedrine ) are the most common treatments for ADHD. Although the effect of abrupt discontinuation of these agents is not well studied, data suggest that they are associated with marked symptom rebound.
Alternatively, no reports exist to date on effects following discontinuation of atomoxetine, a new drug approved for ADHD in the United States. To assess the potential for discontinuation syndrome with Strattera, researchers lead by Joachim F. Wernicke, MD, PhD, of Lilly Research Laboratories, Indianapolis, Indiana, United States assessed outcomes in 4 studies where patients discontinued atomoxetine under controlled conditions.
Two identical paediatric studies and 2 identical adult studies were performed. In paediatric studies, ADHD patients ages 7 to 12 years were randomised to acute treatment with atomoxetine or placebo. At treatment completion, patients entered a single-blind 1-week discontinuation phase in which all patients received placebo.
Similarly, adult ADHD patients were randomised to acute treatment with atomoxetine or placebo. At treatment completion, patients entered a 4-week double-blind discontinuation phase, during which patients taking atomoxetine were randomised to abrupt or tapered discontinuation, and patients assigned to placebo continued on placebo.
The effects of atomoxetine (Strattera) discontinuation were assessed following 9 to 10 weeks of continuous therapy.
Across all studies, ADHD symptoms after Strattera discontinuation did not rise to or exceed pretreatment values. Furthermore, the incidence of discontinuation-emergent adverse events was low, no statistically significant differences were found between patients discontinuing atomoxetine and those on placebo, and no clinically significant changes in laboratory values were associated with atomoxetine use or discontinuation.
Based on the data, the investigators conclude that there is no safety concern related to abrupt atomoxetine discontinuation.
This study was funded by Eli Lilly and Company.
Source: J Clin Psychopharmacol 2004 Feb;24:1:30-5. "Changes in symptoms and adverse events after discontinuation of atomoxetine in children and adults with attention deficit/hyperactivity disorder: a prospective, placebo-controlled assessment"
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