Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: Results from a 12-month observational study.

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. Conclusion This study is in line with some recent studies and provides further evidence that buprenorphine-naloxone is relatively safe with respect to liver injury. (Am J Addict 2014;23:563-569) [ABSTRACT FROM AUTHOR]