Efficacy and Safety of Omega-3 Fatty Acids in the Prevention of Cardiovascular Disease: A Systematic Review and Meta-analysis.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 36103100 · doi:10.1007/s10557-022-07379-z
What was done
Authors conducted a systematic review and meta-analysis of 15 randomized controlled trials to evaluate the efficacy and safety of omega-3 fatty acid supplements for cardiovascular disease prevention. Primary efficacy outcomes were major cardiovascular events, myocardial infarction, heart failure, atrial fibrillation, stroke, cardiovascular death, and all-cause death. Safety endpoints were gastrointestinal issues, bleeding-related disorders, and cancer. Pooled estimates were calculated using random-effects models, with subgroup analyses and meta-regression for dose-response relationships.
What was found
Omega-3 supplementation reduced major cardiovascular events (RR 0.95, 95% CI 0.91 to 0.99, P = 0.026), myocardial infarction (RR 0.90, 95% CI 0.83 to 0.98, P = 0.021), and cardiovascular death (RR 0.94, 95% CI 0.88 to 0.99, P = 0.028). However, it increased the risk of atrial fibrillation (RR 1.25, 95% CI 1.10 to 1.41, P = 0.000). No significant differences were seen for heart failure, stroke, all-cause death, gastrointestinal problems, bleeding disorders, or cancer overall. Subgroup analysis attributed cardiovascular benefits primarily to prescription EPA ethyl ester, which also exhibited a higher bleeding risk.
Why it matters
This meta-analysis demonstrates that the modest ischemic and mortality benefits of omega-3 supplementation—predominantly driven by prescription EPA ethyl ester—are counterbalanced by a 25% increase in atrial fibrillation risk and formulation-specific bleeding risks.
Limits
The total number of enrolled participants is not reported in the abstract. Numerical effect sizes and confidence intervals are omitted for subgroup findings, including stroke risk in patients with prior myocardial infarction and bleeding risk for EPA ethyl ester. Dosing variations and trial follow-up durations are not specified.
Cited by
- partial Despite the observed increase in atrial fibrillation with high-dose omega-3, there is no increased risk for stroke, and instead there is a decreased risk for stroke.