Meta-analysis supports safety of oral naltrexone

  • Bolton M & al.
  • BMC Med
  • 15 Jan 2019

  • curated by Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • A large meta-analysis of 86 randomized clinical trials with more than 11,000 patients found no significant increased risk for serious adverse events (SAEs) from oral naltrexone vs placebo.
  • Certain AEs such as dizziness and vomiting were more common with oral naltrexone, although those data came from only a few studies.

Why this matters

  • Concerns exist regarding liver toxicity and other hazards with long-term use.

Study design

  • Randomized controlled trials on oral naltrexone (>4 weeks) published after January 1, 2001, were identified for this systematic review (86 studies; n=10,957) and meta-analysis (76 studies).
  • Funding: No external funding.

Key results

  • SAEs were analyzed from 31 comparisons (26 studies).
  • Naltrexone vs placebo showed no significant increase in the risk for SAEs (risk ratio [RR], 0.84; 95% CI, 0.66-1.06).
  • Pooled sensitivity analysis for the number of participants experiencing at least 1 SAE for naltrexone vs placebo was not significant (risk difference, −0.01; 95% CI, −0.02 to 0.00).
  • Certain AEs such as dizziness (RR, 1.45; 95% CI, 1.15-1.83) and vomiting (RR, 1.91; 95% CI, 1.51-2.42) were more common with naltrexone vs placebo.

Limitations

  • Findings should be interpreted with caution.

Coauthored with Chitra Ravi, MPharm

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