Clinical

CORRECTION: Baclofen safely promotes alcohol abstinence in cirrhotic patients

Last Updated: 2007-12-20 8:02:14 -0400 (Reuters Health)

[Corrects item 20071206clin007 posted December 6, 2007. Changes "... the 31% rate seen in the baclofen group..." to "... the 31% rate seen in the placebo group..." in the 6th paragraph.]

By Anthony J. Brown, MD

NEW YORK (Reuters Health) - Baclofen, a GABA B-receptor agonist, is a safe and effective treatment for maintaining alcohol abstinence in alcohol-dependent patients with liver cirrhosis, according to a new report.

"This is the first study which tested a drug with the aim to reduce craving for alcohol and to increase alcohol abstinence in alcoholic patients affected by liver cirrhosis," lead author Dr. Giovanni Addolorato told Reuters Health. "Although these patients need to maintain alcohol abstinence, usually they are excluded from trials with anticraving drugs because of concerns that these medications might worsen liver disease."

He explained that his group decided to test baclofen in this population because it is metabolized mostly by the kidneys, not the liver. Moreover, in previous studies of alcoholics without cirrhosis, the drug was effective and not associated with liver side effects.

The study, which is reported in the December 8th issue of The Lancet, involved 84 patients who were randomized to receive oral baclofen or placebo for 12 weeks.

Patients treated with baclofen were significantly more likely to achieve and maintain abstinence (71%) than were controls (29%), which translates to an odds ratio of 6.3, Dr. Addolorato, from the Catholic University of Rome, and colleagues report. The cumulative abstinence duration in the baclofen group averaged 62.8 days, roughly twice as long as the 30.8 days noted in the placebo group (p = 0.001).

Baclofen therapy was well tolerated and no hepatic adverse effects were observed. The treatment termination rate in the baclofen group was 14%, lower but not significantly different from the 31% rate seen in the placebo group (p = 0.12).

The "finding that baclofen ... was better than placebo for reduction of drinking in such patients is of interest both because of its specific results and because it highlights the broader context of drug treatment for alcoholism," Dr. James C. Garbutt, from the University of North Carolina at Chapel Hill, and Dr. Barbara Flannery, from the Transdisciplinary Behavioral Science Program, write in a related editorial.

While the current findings are encouraging, Dr. Addolorato said further "studies are needed to define the best duration of treatment, to assess possible tolerance to baclofen in a more prolonged regimen, and to define the role of baclofen in clinical practice."

Lancet 2007;370:1884-1885,1915-1922.