Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection

L. Leggio, A. Ferrulli, A. Zambon, F. Caputo, G. A. Kenna, R. M. Swift, G. Addolorato

Research output: Contribution to journalArticle

40 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)561-564
Number of pages4
JournalAddictive Behaviors
Volume37
Issue number4
DOIs
Publication statusPublished - Apr 2012

Fingerprint

Alcohol Abstinence
Baclofen
Virus Diseases
Viruses
Hepacivirus
Alcohols
Liver
Drug therapy
Placebos
International Normalized Ratio
Albumins
Alcoholism
GABA-B Receptor Agonists
Drug Therapy
Alcoholic Liver Diseases
Western World
Liver Function Tests
Drinking
Liver Diseases
Fibrosis

Keywords

  • Alcohol dependence
  • Alcohol pharmacotherapy
  • Alcoholic liver disease
  • Baclofen
  • Cirrhosis
  • Hepatitis C virus

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology
  • Toxicology
  • Medicine (miscellaneous)

Cite this

Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. / Leggio, L.; Ferrulli, A.; Zambon, A.; Caputo, F.; Kenna, G. A.; Swift, R. M.; Addolorato, G.

In: Addictive Behaviors, Vol. 37, No. 4, 04.2012, p. 561-564.

Research output: Contribution to journalArticle

Leggio, L. ; Ferrulli, A. ; Zambon, A. ; Caputo, F. ; Kenna, G. A. ; Swift, R. M. ; Addolorato, G. / Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. In: Addictive Behaviors. 2012 ; Vol. 37, No. 4. pp. 561-564.
@article{5f551606171649c2b8658f4384c8c527,
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.",
keywords = "Alcohol dependence, Alcohol pharmacotherapy, Alcoholic liver disease, Baclofen, Cirrhosis, Hepatitis C virus",
author = "L. Leggio and A. Ferrulli and A. Zambon and F. Caputo and Kenna, {G. A.} and Swift, {R. M.} and G. Addolorato",
year = "2012",
month = "4",
doi = "10.1016/j.addbeh.2011.12.010",
language = "English",
volume = "37",
pages = "561--564",
journal = "Addictive Behaviors",
issn = "0306-4603",
publisher = "Elsevier Limited",
number = "4",

}

TY - JOUR

T1 - Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection

AU - Leggio, L.

AU - Ferrulli, A.

AU - Zambon, A.

AU - Caputo, F.

AU - Kenna, G. A.

AU - Swift, R. M.

AU - Addolorato, G.

PY - 2012/4

Y1 - 2012/4

N2 - 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.

AB - 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.

KW - Alcohol dependence

KW - Alcohol pharmacotherapy

KW - Alcoholic liver disease

KW - Baclofen

KW - Cirrhosis

KW - Hepatitis C virus

UR - http://www.scopus.com/inward/record.url?scp=84857055921&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84857055921&partnerID=8YFLogxK

U2 - 10.1016/j.addbeh.2011.12.010

DO - 10.1016/j.addbeh.2011.12.010

M3 - Article

C2 - 22244707

AN - SCOPUS:84857055921

VL - 37

SP - 561

EP - 564

JO - Addictive Behaviors

JF - Addictive Behaviors

SN - 0306-4603

IS - 4

ER -