Topiramate significantly improves several outcome measures in alcohol-dependent patients including number of heavy drinking days, number of drinks per day and days of continuous abstinence, according to an article in the October 10 issue of Journal of the American Medical Association.

According to background information in the article, a previous, shorter trial indicated that topiramate, a medication developed as an antiepileptic agent, may be beneficial for treatment of alcohol dependence.

Bankole A. Johnson, DSc, MD, PhD, of the University of Virginia, Charlottesville, and colleagues conducted a multisite, 14-week, randomized controlled trial to determine the efficacy of topiramate compared with placebo. The study, which included 371 men and women age 18 to 65 years diagnosed with alcohol dependence, was conducted between January 2004 and August 2006 at 17 U.S. sites.

Participants received up to 300 mg/day of topiramate (183 patients) or placebo (188 patients), along with weekly psychosocial treatment to promote adherence with study medication and treatment regimen.

Treating all dropouts as relapse to baseline, topiramate compared with placebo showed greater reduction of percentage of heavy drinking days from baseline to week 14 (from an average of 81.9 percent to 43.8 percent for topiramate versus 82.0 percent to 51.8 percent for placebo). Prespecified analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (average difference, 16.19 percent).

Further, topiramate compared with placebo was associated with a significantly higher rate of achieving 28 or more days of continuous nonheavy drinking and 28 or more days of continuous abstinence. Adverse events that were more common with topiramate included paresthesia, taste perversion, anorexia, and difficulty with concentration.

“Our finding in this study that topiramate is a safe and consistently efficacious medication for treating alcohol dependence is scientifically and clinically important. Alcoholism ranks third and fifth on the U.S. and global burdens of disease, respectively. Discovering pharmacological agents such as topiramate that improve drinking outcomes can make a major contribution to global health. Because topiramate pharmacotherapy
can be paired with a brief intervention deliverable by nonspecialist health practitioners, a next step would be to examine its efficacy in community practice settings,” the authors concluded.