title: Preliminary findings on the use of metadoxine for the treatment of alcohol dependence and alcoholic liver disease.
abstract: OBJECTIVE
  Metadoxine is approved in Europe for alcohol intoxication and is also indicated for alcoholic liver disease (ALD). This study aims to investigate the use of metadoxine as a potential pharmacotherapy for alcohol dependence (AD).
  
  
  METHODS
  This is a retrospective study of 94 outpatients with AD, who received metadoxine for alcohol intoxication and were assessed for alcohol consumption, craving [Visual Analog Scale (VAS)] and liver-related and alcohol-related biomarkers [aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl-transpeptidase, mean corpuscular volume].
  
  
  RESULTS
  Range of metadoxine dose was 500-2000 mg/day, with a mean dose of 1277(s.d.290) mg/day, and for a period of 2-42 days, with a mean period of 8.9(s.d.7.0) days. Follow-up data were available for 52 patients (55.3%); 35(67.3%) patients were completely abstinent. There was a significant decrease in drinks per week, even after substituting baseline drinking as follow-up data for dropouts (p < 0.001) and examining drinking pre-treatment and post-treatment for those who did not achieve abstinence (p < 0.001). There was a significant decrease in the VAS (p < 0.001) and a significant improvement in the AST/ALT ratio (p = 0.03).
  
  
  CONCLUSIONS
  Despite important limitations, this study represents a further preliminary observation suggesting metadoxine as a novel alcohol pharmacotherapy, including in alcohol-dependent patients with ALD.
authors.affiliation: Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island 02912, USA. Lorenzo_Leggio@brown.edu
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Leggio
authors.forename: George A
authors.initials: GA
authors.lastname: Kenna
authors.forename: Anna
authors.initials: A
authors.lastname: Ferrulli
authors.forename: William H
authors.initials: WH
authors.lastname: Zywiak
authors.forename: Fabio
authors.initials: F
authors.lastname: Caputo
authors.forename: Robert M
authors.initials: RM
authors.lastname: Swift
authors.forename: Giovanni
authors.initials: G
authors.lastname: Addolorato
mesh_terms: D000328:Adult; D000427:Alcohol Deterrents / Q000627:therapeutic use; D000437:Alcoholism / Q000188:drug therapy* / Q000453:epidemiology*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008108:Liver Diseases, Alcoholic / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D011736:Pyridoxine / Q000627:therapeutic use*; D011761:Pyrrolidonecarboxylic Acid / Q000627:therapeutic use*; D012189:Retrospective Studies
chemical_list: D000427:Alcohol Deterrents; D004338:Drug Combinations; C037845:metadoxine; D011736:Pyridoxine; D011761:Pyrrolidonecarboxylic Acid