Anti-alcohol drug safe in cases of liver cirrhosis

By Anthony J. Brown, MD

NEW YORK (Reuters Health) - The muscle-relaxing drug baclofen safely and effectively keeps alcoholics with alcohol-damaged livers away from alcohol, according to a study published in the current issue of The Lancet.

"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 involved 84 patients who were randomized to receive baclofen pills or placebo for 12 weeks. Patients treated with baclofen were much more likely to achieve and maintain abstinence (71 percent) than were controls (29 percent), Addolorato, from the Catholic University of Rome, and colleagues report.

Patients taking baclofen also abstained from alcohol for more than twice as long as patients given placebo (62.8 days versus 30.8 days).

Baclofen therapy was well tolerated and no liver-related side effects.

Alcohol remains the chief cause of liver cirrhosis in developed countries, the investigators note in their report. Persistent alcohol intake in people with alcoholic cirrhosis often leads to death. Individuals with alcoholic liver disease need to achieve total alcohol abstinence, since medical and surgical treatments for alcoholic liver diseases have limited success when drinking continues, they further note.

"Our results suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease," the investigators conclude.

SOURCE: Lancet, December 8, 2007.