No Elevated Liver Damage in Buprenorphine/Naloxone Trial

by U.S. Medicine

February 8, 2013

SEATTLE — Buprenorphine/naloxone (BUP) and methadone (MET) are effective in treatment of opioid dependence, but some concerns have been raised about a link between the use of BUP and drug-induced hepatitis.

A new study from VA Puget Sound Health Care System in Seattle sought to compare the effects of BUP and MET on liver health in opioid-dependent participants.1

“This study demonstrated no evidence of liver damage during the initial 6 months of treatment in either condition,” according to the authors. “Physicians can prescribe either medication without major concern for liver injury.”

The research, published in the journal Drug and Alcohol Dependence, was led by Andrew J. Saxon, MD, of the Seattle VAMC.

For the study, 1,269 opioid-dependent participants seeking treatment at eight federally licensed opioid treatment programs were followed in a randomized controlled trial for up to 32 weeks between May 2006 and August 2010. Participants were randomly assigned to receive BUP or MET for 24 weeks.

Criteria suitable for evaluation were met by 731 participants who completed 24 weeks of medication and provided at least four blood samples for transaminase testing.

Researchers found that changes in transaminase levels did not differ according to medication. In fact, the only significant predictor of moving from low to elevated transaminase levels was baseline infection with hepatitis C or B.

During the study, 9 BUP and 15 MET participants showed extreme liver test elevations and were more likely than those without extreme elevations to have seroconverted to both hepatitis B and C during the study or to use illicit drugs during the first eight weeks of treatment, according to the authors.

The study noted that MET participants were retained longer in treatment than BUP participants.

  1. Saxon AJ, Ling W, Hillhouse M, Thomas C, et. al. Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: A randomized trial. Drug Alcohol Depend. 2012 Aug 22. [Epub ahead of print] PubMed PMID: 22921476.

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