Meta-analysis does not find increased risk of bleeding events from omega-3 PUFA consumption

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A recent meta-analysis¹ found that consumption of omega-3 polyunsaturated fatty acids (PUFA) was not associated with an elevated risk of bleeding. Researchers reviewed 11 studies and found that there was no difference in the incidence of bleeding events between patients receiving omega-3 PUFAs and those not receiving them. When looking at EPA specifically, researchers observed that administration of high-dose purified EPA was associated with a 50% higher risk of bleeding compared to control, but absolute increase in bleeding was rather modest. The risk translated to a number needed to hard of 166, meaning that one out of every 166 patients might experience a bleeding event.

With regard to hemorrhagic stroke, risk was comparable between patients receiving and not receiving omega-3 PUFAs, and when restricted to randomized trails of EPA only, the risk was similar here as well. The incidence of intracranial bleeding events did not differ between the omega-3 PUFA and EPA-only treatment groups, and researchers found no association between omega-3 PUFAs and gastrointestinal bleeding. When researchers plotted the administered dose of EPA against the difference in bleeding risk between omega-3 PUFA and control, they found a significant relationship between the daily dose in grams and increased bleeding risk. The same association was not found in patients received anti-platelet therapy.

“Overall, the increase in bleeding risk associated with high‐dose EPA was very modest. The absolute increase in the overall bleeding risk was 0.6% with no evidence to suggest an increase in serious bleeding such as intracranial or hemorrhagic stroke. Furthermore, there was no relationship between bleeding events and the background use of antiplatelet treatment in patients receiving omega‐3 PUFAs,” wrote the researchers. They go on to explain that a REDUCE-IT substudy reported similar total bleeding events in patients with a history of previous percutaneous coronary intervention who were randomly assigned to icosapent ethyl (EPA) or placebo. The researchers also explain that early initiation of EPA in patients with acute coronary syndrome has not been shown in research to cause harm, but rather significantly reduce major adverse vascular events, including cardiovascular mortality compared to standard therapy for post–percutaneous coronary intervention.

Reference

1. Javaid, M.; Kadkim, K.; Bawamia, B.; Cartlidge, T.; Farag, M.; Alkhalil, M. Bleeding Risk in Patients Receiving Omega‐3 Polyunsaturated Fatty Acids: A Systematic Review and Meta‐Analysis of Randomized Clinical Trials. Journal of America Heart Association. 2024, 13 (10). DOI: 10.1161/JAHA.123.032390