Table 1.
Summary of key randomized controlled trials
| Author (Year) | Design | Intervention | Patient population | Follow-up, years | Results |
|---|---|---|---|---|---|
| GISSI-Prevenzione Investigators (1999)6 | R, OL | 1 g omega-3 PUFAs (290 mg EPA/580 mg DHA) vs no intervention | N = 11,324Inclusion: MI within 3 monthsBaseline: 84% aged ≤70, 15% female | 3.5 | Composite of all-cause death, nonfatal MI or nonfatal stroke: 12.6% omega-3 PUFAs vs 13.9% control, RR 0.90 (95% CI, 0.82–0.99) |
| Yokoyama et al. (2007)7 | R, OL | 1800 mg EPA with statin vs statin monotherapy | N = 18,645Inclusion: total cholesterol ≥6.5 mmol/LBaseline: mean age 61 years; 69% female, 20% CAD | 4.6 (mean) | Composite of SCD, fatal and nonfatal MI, UA, coronary angioplasty or stenting, or CABG: 2.8% EPA vs 3.5% control, HR 0.81 (95% CI, 0.69–0.95) |
| Rauch et al. (2010)8 | R, DB, PC | 1 g omega-3 PUFAs (460 mg EPA/380mg DHA) vs PC | N = 3851Inclusion: MI within 3–14 daysBaseline: mean age 64 years, 26% female | 1 | SCD: 1.5% omega-3 PUFAs vs 1.5% PC, OR 0.95 (95% CI, 0.56–1.60) MACCE: 10.4% omega-3 PUFAs vs 8.8% PC, OR 1.21 (95% CI, 0.96–1.52) |
| Galan et al. (2010)9 | R, DB, PC | 600 mg omega-3 PUFAs (EPA:DHA ratio 2:1) vs PC | N = 2501Inclusion: acute coronary or cerebral ischemic event within 12 monthsBaseline: mean age 61 years, 20% female | 4.7 (median) | Composite of nonfatal MI, stroke or CV death: 6.5% omega-3 PUFAs vs 6.1% placebo, HR 1.08 (95% CI, 0.79–1.47) |
| Kromhout et al. (2010)10 | R, DB, PC | 18.8 g margarine containing omega-3 fatty acids (226 mg EPA/150 mg DHA) vs PC | N = 4837Inclusion: MI up to 10 years before randomizationBaseline: mean age 69 years, 22% female | 3.4 (median) | Composite of fatal or nonfatal CVD, PCI or CABG: 14.0% omega-3 fatty acids vs 13.8% PC, HR 1.01 (95% CI, 0.87–1.17) |
| ORIGIN Trial Investigators et al. (2012)11 | R, DB, PC | 1 g omega-3 PUFAs (465 mg EPA/375 mg DHA) vs PC | N = 12,536Inclusion: IFG, IGT, or DM and high-risk for CV eventBaseline: mean age 64 years, 35% female, 60% CVD | 6.2 (median) | Death from CV causes: 9.1% omega-3 PUFAs vs 9.3% PC, HR 0.98 (95% CI, 0.87–1.10) |
| Risk and Prevention Study Collaborative Group (2013)12 | R, DB, PC | 1 g omega-3 fatty acids (500–660 mg EPA/330–500 mg DHA) vs PC | N = 12,513Inclusion: multiple CV risk factors or atherosclerotic vascular disease, but not previous MIBaseline: mean age 64 years, 39% female, 30% atherosclerotic disease | 5 (median) | Composite of death, nonfatal MI, nonfatal stroke, CV death or CV hospitalization: 11.7% omega-3 PUFAs vs 11.9% PC, HR 0.97 (95% CI, 0.88–1.08) |
| Writing Group for the AREDS2 Research Group (2014)13 | R, DB, PC | 1 g omega-3 PUFAs (650 mg EPA/350 mg DHA) vs PC | N = 4203Inclusion: macular degenerationBaseline: median age 74 years, 57% female, 19% CVD | 4.8 (median) | Composite of CV death, MI, stroke, UA, coronary or carotid revascularization, CHF hospitalization, resuscitated cardiac arrest: 9% omega-3 PUFAs vs 9% PC, HR 0.95 (95% CI, 0.78–1.17) |
ACS, acute coronary syndrome; AREDS2, Age-Related Eye Disease Study 2; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CHF, congestive heart failure; CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; DB, double-blind; DHA, docosahexaenoic acid; DM, diabetes mellitus; EPA, eicosapentaenoic acid; GISSI, Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico; HR, hazard ratio; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MACCE, major adverse cerebrovascular and cardiovascular events; MI, myocardial infarction; OL, open label; OR, odds ratio; ORIGIN, Outcome Reduction with an Initial Glargine Intervention; PC, placebo; PCI, percutaneous coronary intervention; PUFA, polyunsaturated fatty acids; R, randomized; RR, relative risk; SCD, sudden cardiac death; UA, unstable angina.