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More than 2,000 clinical trials on the effects of omega-3s have been conducted in humans, including four large, prospective long-term, randomized, controlled trials. Additionally, multiple evidence-based reviews and meta-analyses have shown significant reductions in chronic disease risk with increased consumption of EPA and DHA. GOED has also funded meta-analyses that have been used by international regulatory bodies to approve health claims.
Large Prospective Human Trials
GISSI-Prevenzione Study[1] 
The GISSI-Prevenzione study investigated the effects of EPA and DHA omega-3s in patients who had survived recent myocardial infarctions. It established that 1g of EPA and DHA per day reduced the risk of all-cause mortality between 14% and 20% and the risk of cardiac mortality between 17% and 30%. The study followed 8,488 patients for 3.5 years. The researchers noted that the effects of EPA and DHA were both clinically important and strongly statistically significant. A follow-up paper from the investigators also found that EPA and DHA were more cost effective than some statins at reducing all-cause deaths following the initial myocardial infarction [2].
GISSI-HF Study[3]
The GISSI-HF study established that 1g of EPA and DHA per day reduced the risk of all-cause mortality by an average of 9% (p=0.041) in patients who are already being treated for heart failure, and the risk of cardiac mortality and hospitalization by 8% (p=0.009). The study was conducted at 326 cardiology centers and 31 internal medicine centers, following 6,975 heart failure patients for up to 4.5 years. Importantly, the study found that omega-3s can provide a beneficial additional advantage when used with a traditional care regimen for heart failure.
JELIS Study[4]
The JELIS study found that 1.8g of EPA per day reduced the risk of major coronary events by 19% over statin-therapy alone in patients being treated for hypercholesterolemia with statins. The study followed 18,645 patients in Japan for five years. The study also found that EPA reduced the risk of unstable angina and non-fatal coronary events in the population. Multiple sub-analyses have been performed on the data from the JELIS study as well. One analysis found that EPA reduced the risk of stroke recurrences by 20% and recommended further study in populations that do not already eat large amounts of fish [5]. Another analysis found that patients with high triglyceride and low HDL cholesterol levels had a 71% higher risk of coronary artery disease events, but EPA reduced the risk of a first event in this sub-group by 53% [6]. Another analysis in patients who had already experienced CAD events found that EPA reduced the risk of any secondary major coronary event by 23% and myocardial infarctions by 27% [7]. DART Study [8]
The DART study was published in 1989 and established the basis for many of today's recommendations that everybody consume two servings of fatty fish, which supply high levels of EPA and DHA, per week. The study followed 2,033 men who had suffered a myocardial infarction for two years. Increased fatty fish intake reduced all-cause mortality by 29%.
References
[1] GISSI-Prevenzione Investigators (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico). Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet. 1999 Aug; 354(9177):447-55.
[2] Franzosi MG, Brunetti M, Marchioli R, Marfisi RM, Tognoni G, et al. Cost-effectiveness analysis of n-3 polyunsaturated fatty acids (PUFA) after myocardial infarction: results from Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-Prevenzione Trial. Pharmacoeconomics. 2001;19(4):411-20.
[3] Gissi-HF Investigators, Tavazzi L, Maggioni AP, Marchioli R, Barlera S, et al. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1223-30.
[4] Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007 Mar 31;369(9567):1090-8.
[5] Tanaka K, Ishikawa Y, Yokoyama M, Origasa H, Matsuzaki M, et al. Reduction in the recurrence of stroke by eicosapentaenoic acid for hypercholesterolemic patients: subanalysis of the JELIS trial. Stroke. 2008 Jul;39(7):2052-8.
[6] Saito Y, Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, et al. Effects of EPA on coronary artery disease in hypercholesterolemic patients with multiple risk factors: sub-analysis of primary prevention cases from the Japan EPA Lipid Intervention Study (JELIS). Atherosclerosis. 2008 Sep;200(1):135-40.
[7] Matsuzaki M, Yokoyama M, Saito Y, Origasa H, Ishikawa Y, et al. Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery disease. Circ J. 2009 Jul;73(7):1283-90.
[8] Burr ML, Fehily AM, Gilbert JF, Rogers S, Holliday RM, et al. Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART). Lancet. 1989 Sep 30;2(8666):757-61.
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