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Research suggests atomoxetine does not increase smoking in adult smokers with ADHD, but smoking status may predict response to treatment

Tuesday, October 30 2007 | Comments
Evidence Grade 0 What's This?
Among adult smokers with attention-deficit/hyperactivity disorder, atomoxetine does not increase cigarette smoking, according to an analysis of Phase IV data. Additional findings suggest smoking status may affect the likelihood of treatment response in adults with ADHD.

The double-blind study included 218 adults aged 18 to 50 years with ADHD. They were randomized to receive a once-daily dose of atomoxetine 80 mg or a twice-daily dose of atomoxetine 40 mg. In both groups, the drug was initiated at the target dose, and the dose was maintained for 6 weeks of treatment. The primary outcome measures were the relative safety and tolerability profiles of the 2 dosing regimens.

The current post hoc analysis evaluated the effect of the drug on cigarette smoking. The study investigators noted that cigarette smoking is common among adults with ADHD, with 1998 estimates indicating that the prevalence of smoking may be as high as 42% in this population. They added that in preclinical studies, atomoxetine attenuated symptoms of nicotine withdrawal.

There were 14 smokers in the once-daily dosing group and 22 in the twice-daily dosing group who provided baseline and postbaseline data about cigarette smoking. Among these participants, the mean number of cigarettes smoked per week at baseline was 84.9 in the once-daily dosing group and 77.3 in the twice-daily dosing group. After treatment with atomoxetine, the mean number of cigarettes smoked per week increased by 4.1 in the once-daily group and declined by 13.0 in the twice-daily group.

Although the change from baseline in the number of cigarettes smoked per week did not differ significantly between the 2 groups (P=.116), the difference suggested that atomoxetine 40 mg twice daily might decrease smoking behaviors in adults with ADHD relative to a once-daily 80 mg dose, according to the study researchers.

When remission was defined as a Conners' Adult ADHD Rating Scale (CAARS) total score <=12 and a Clinical Global Impressions (CGI)-ADHD-Severity scale score of 1 or 2, 7.5% of smokers met remission criteria compared with 19.4% of nonsmokers (P=.09).

Similarly, when a response to treatment was defined as a reduction in CAARS total score >=25%, 62.5% of smokers met response criteria compared with 76.0% of nonsmokers (P=.11). When a response to treatment was defined as a CGI-ADHD-Improvement scale score of 1 or 2, the proportion of responders was still numerically higher among nonsmokers, but there was no statistical trend suggesting a difference between the 2 groups (P=.86).

"The results of this post hoc analysis suggest that future placebo-controlled studies designed to explore the potential association between smoking status and response to therapy are needed," the authors concluded. (Durell T, et al. Poster D7.)

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