title: Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection.
abstract: Hepatitis C virus (HCV) and alcoholic liver disease (ALD), either alone or in combination, count for more than two thirds of all liver diseases in the Western world. There is no safe level of drinking in HCV-infected patients and the most effective goal for these patients is total abstinence. Baclofen, a GABA(B) receptor agonist, represents a promising pharmacotherapy for alcohol dependence (AD). Previously, we performed a randomized clinical trial (RCT), which demonstrated the safety and efficacy of baclofen in patients affected by AD and cirrhosis. The goal of this post-hoc analysis was to explore baclofen's effect in a subgroup of alcohol-dependent HCV-infected cirrhotic patients. Any patient with HCV infection was selected for this analysis. Among the 84 subjects randomized in the main trial, 24 alcohol-dependent cirrhotic patients had a HCV infection; 12 received baclofen 10mg t.i.d. and 12 received placebo for 12-weeks. With respect to the placebo group (3/12, 25.0%), a significantly higher number of patients who achieved and maintained total alcohol abstinence was found in the baclofen group (10/12, 83.3%; p=0.0123). Furthermore, in the baclofen group, compared to placebo, there was a significantly higher increase in albumin values from baseline (p=0.0132) and a trend toward a significant reduction in INR levels from baseline (p=0.0716). In conclusion, baclofen was safe and significantly more effective than placebo in promoting alcohol abstinence, and improving some Liver Function Tests (LFTs) (i.e. albumin, INR) in alcohol-dependent HCV-infected cirrhotic patients. Baclofen may represent a clinically relevant alcohol pharmacotherapy for these patients.
authors.affiliation: Center for Alcohol and Addiction Studies, Brown University, Providence, RI 02912, USA. Lorenzo_Leggio@brown.edu
authors.forename: L
authors.initials: L
authors.lastname: Leggio
authors.forename: A
authors.initials: A
authors.lastname: Ferrulli
authors.forename: A
authors.initials: A
authors.lastname: Zambon
authors.forename: F
authors.initials: F
authors.lastname: Caputo
authors.forename: G A
authors.initials: GA
authors.lastname: Kenna
authors.forename: R M
authors.initials: RM
authors.lastname: Swift
authors.forename: G
authors.initials: G
authors.lastname: Addolorato
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000427:Alcohol Deterrents / Q000627:therapeutic use*; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D001418:Baclofen / Q000627:therapeutic use*; D005260:Female; D058786:GABA-B Receptor Agonists / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D008104:Liver Cirrhosis, Alcoholic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D013695:Temperance; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000427:Alcohol Deterrents; D058786:GABA-B Receptor Agonists; D001418:Baclofen