title: Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: results from a 12-month observational study.
abstract: BACKGROUND
  Some case series mention possible liver toxicity in opioid-dependent patients under buprenorphine treatment.
  
  
  METHODS
  This 12-month prospective observational follow-up study in opioid-dependent patients under buprenorphine-naloxone treatment assessed outcome and safety issues. At baseline, 337 eligible datasets were available; 181 patients completed the 12-month study. Liver enzymes were tested at baseline and after 12, 24, and 52 weeks' treatment.
  
  
  RESULTS
  One to two percent of patients showed mostly discrete elevations of liver enzymes, but no patient met the criteria for drug-induced liver injury. No serious liver-related adverse events occurred, but two non-serious cases of liver enzyme increase were recorded. No patient dropped out of treatment for liver-related disorders.
  
  
  CONCLUSIONS
  This study is in line with some recent studies and provides further evidence that buprenorphine-naloxone is relatively safe with respect to liver injury.
authors.affiliation: Department of Psychiatry, Ludwig Maximilian University, Munich, Germany; Private Hospital Meiringen, Meiringen, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Soyka
authors.forename: Markus
authors.initials: M
authors.lastname: Backmund
authors.forename: Peggy
authors.initials: P
authors.lastname: Schmidt
authors.forename: Sabine
authors.initials: S
authors.lastname: Apelt
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D002047:Buprenorphine / Q000009:adverse effects*; D000069479:Buprenorphine, Naloxone Drug Combination; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000209:etiology*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D009270:Naloxone / Q000009:adverse effects*; D009292:Narcotic Antagonists / Q000009:adverse effects*; D058850:Opiate Substitution Treatment / Q000009:adverse effects*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D011446:Prospective Studies; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase