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Atomoxetine reduces ADHD symptoms, heavy drinking events in adults with ADHD, alcoholism, findings suggest

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
Among adults with attention-deficit/hyperactivity disorder and comorbid alcohol abuse, atomoxetine seems to effectively reduce both ADHD symptoms and cumulative heavy drinking events, data suggest.

The double-blind, placebo-controlled study enrolled 147 adults who met DSM-IV-TR criteria for ADHD and alcohol abuse. Participants had been abstinent from alcohol for >=4 days and <=30 days at baseline.

Participants were randomized to atomoxetine 25 mg/day to 100 mg/d (n=72; taken in single or equally divided dose) or placebo (n=75) for 12 weeks. ADHD symptoms were assessed with the ADHD Investigator Symptom Rating Scale (AISRS). Alcohol use was assessed by measuring the time from first dose of study medication to relapse of drinking, defined as 4 to 5 standard drinks in one day (4 drinks for females, 5 for males) or >=3 standard drinks per day for ≥1 week.

The between-group difference in time to relapse of drinking was not significant (P=.934). However, a multiple event analysis showed that the atomoxetine arm experienced a 26.3% greater reduction in cumulative heavy drinking events relative to the placebo arm (P=.023); this difference between atomoxetine and placebo was first significant on day 55 of treatment.

Atomoxetine also significantly improved AISRS scores. Relative to baseline, mean AISRS total score decreased 13.63 points compared with an 8.31-point decrease in the placebo group (P=.007). Significant differences favoring atomoxetine were also observed for the AISRS hyperactive/impulsive subscale (P=.009) and the inattentive subscale (P=.013).

Adverse events in this study were consistent with previous studies of atomoxetine, the authors noted, and consisted mainly of weight loss. There was also a significantly greater decrease in QT interval among atomoxetine-treated patients as compared with placebo-treated patients.

The authors concluded, "ADHD can be treated safely and effectively with atomoxetine in patients who have a history of alcohol dependence or abuse …. Atomoxetine may also help reduce the incidence of heavy drinking days in patients with ADHD and comorbid alcohol use disorder." (Wilens TE, et al. Poster NR649).

This information concerns a use that has not been approved by the Food and Drug Administration.

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