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October 9, 2007 — Alcohol-dependent patients who received the medication topiramate had fewer heavy drinking days, fewer drinks per day, and more days of continuous abstinence than those who received placebo, according to a study in the October 10 issue of the Journal of the American Medical Association.
According to background information in the article, a previous, shorter trial indicated that topiramate, a medication used in the treatment of seizures, may be beneficial for the treatment of alcohol dependence.
Bankole A. Johnson, D.Sc., M.D., Ph.D., of the University of Virginia, Charlottesville, Va., 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. The participants received up to 300 mg/day of topiramate (n = 183) or placebo (n = 188), along with a weekly psychosocial treatment to promote adherence with the study medication and the treatment regimen.
Treating all dropouts as relapse to baseline, topiramate compared with placebo recipients 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 vs. 82.0 percent to 51.8 percent for placebo; average difference, 8.44 percent). Prespecified analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (average difference, 16.19 percent).
The researchers also found that topiramate compared with placebo treatment 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 vs. placebo included paresthesia (abnormal skin sensations), 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 United States 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 conclude.
In an accompanying editorial, Mark L. Willenbring, M.D., of the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Md., writes that alcohol dependence is a disease that needs greater attention in the health care community.
"Alcohol dependence is the third leading modifiable cause of death in the United States, accounting for about 85,000 deaths per year. Reducing incidence, shortening the course, and reducing the severity of episodes are valuable and important goals. Reducing the public health burden will involve addressing the needs of a broader range of patients than can be treated by the specialty treatment system. In particular, it will be important to reduce disability caused by currently untreated episodes of dependence among those with the nonrelapsing form of the illness."
"By historical standards, the pace of medication development for treating this disorder is increasing, and a variety of medications with different modes of action are now available. A solid understanding of the neurobiology of alcohol addiction is providing the framework for multiple avenues of further medication development. The behavioral platform required to support medication treatment is similar to that for depression, attention-deficit/hyperactivity disorder, diabetes and other chronic illnesses, and thus could potentially fit into general medical practice."