Omega-3 added to statins in high-risk patients falls flat, trial ended early

  • Nicholls SJ & al.
  • JAMA
  • 15 Nov 2020

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Adding omega-3 fatty acids to statin therapy in patients at high cardiovascular risk yields no benefit in terms of major adverse cardiac events (MACE).
  • This randomized controlled trial was stopped early.

Why this matters

  • Studies of omega-3s have yielded mixed results.
  • This trial used a carboxylic acid formulation containing eicosapentaenoic acid and docosahexaenoic acid.
  • Editor’s note says no one can be confident that omega-3s offer any health benefit, calls for postmarketing clinical trial of high-dose icosapent ethyl vs corn oil, the comparator used in this study.
  • Editorial: findings counter positive results from REDUCE-IT trial, which used the icosapent ethyl formulation.

Key results

  • 13,078 patients, 675 sites, 22 countries, enrolled October 30, 2014-June 14, 2017.
  • Median treatment period for study drug: 38.2 (interquartile range, 30.5-44.9) months.
  • Trial halted at interim analysis because results indicated low likelihood that the intervention was offering any clinical benefit.
  • 12.0% in omega-3 group had the primary endpoint (MACE) vs 12.2% receiving corn oil.
  • Those in the omega-3 group had more gastrointestinal complaints.

Study design

  • Participants received 4 g/day omega-3 (n=6539) or corn oil (n=6539); continued regular therapies, including statins.
  • Funding: AstraZeneca AB.

Limitations

  • All patients had high MACE risk, so generalization unclear.
  • Single dose evaluated.