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. 2021 Jun 4;10(11):2495. doi: 10.3390/jcm10112495

Table 1.

The overview of the largest clinical trials about omega-3 fatty acids and cardiovascular outcome.

Reference Sample Size Omega-3 Fatty Acid Inclusion Criteria Follow-Up Period (Years) Main Findings
JELIS [33] 18,645 EPA Patients with or without CAD (previous MI, PCI or confirmed angina pectoris) 4.6 EPA reduced all-cause mortality in secondary, but not in primary prevention.
ORIGIN [34] 12,536 n-3 fatty acids Patients at high risk of CV events and with imapired fasting glucose, glucose intolerance or DM 6.2 No reduction in rate of CV events (non-fatal MI or stroke, death from CV cause or arrhythmia) among patients who received omega-3 fatty acids in patients at high CV risk in primary prevention.
ASCEND [35] 15,480 EPA + DHA Patients older than 40 years with DM, but without CVD 7.4 No effect on CV events (non-fatal MI or stroke, transient ischemic attack, or vascular death, excluding confirmed intracranial hemorrhage) among patients who received omega-3 fatty acids.
VITAL [36] 25,871 EPA + DHA Healthy subjects (men > 50 years and women > 55 years) 5.3 No effect on CV events (MI, stroke, CV death) among patients who received omega-3 fatty acids.
REDUCE-IT [6] 8,179 Icosapent ethyl Patients with established CVD or DM on statin therapy with increased TG 4.9 The risk of ishemic events (CV death, MI, revascularization, unstable angina) was significantly lower in patients tretaed with icosapent ethyl.
EVAPORATE [7] 80 Icosapent ethyl Patients with confirmed coronary artery stenosis, on statin therapy with elevated TG 1.5 Patients on icosapent ethyl therapy experienced a significant reduction in low-attenuation plaque volume and thickening of fibrotic cap, which stabilizes plaque and prevents its rupture.
STRENGTH [37] 13,078 EPA + DHA Established CVD or high risk for CVD 3.5 No significant effect of omega-3 fatty acids on CV death, non-fatal MI and stroke, coronary revascularization, and unstable angina.

CAD—coronary artery disease, CV—cardiovascular, CVD—cardiovascular disease, DHA—docosahexaenoic acid, DM—diabetes mellitus, EPA—eicosapentaenoic acid, MI—myocardial infarction, PCI—percutaneous coronary intervention.