Table 1.
Large randomised controlled trials of n-3 polyunsaturated fatty acids (PUFA) and CVD*
| Trials | Population/background fish or n-3 PUFA intake | Intervention | Duration of follow-up | Events | RR (95% CI) | Achieved power† |
|---|---|---|---|---|---|---|
| DART22 | 2033 men with recent (average ~1 month prior) MI | Advice to consume fatty fish 2 servings/week versus usual care | 2 years | IHD events, n=276 IHD deaths, n=194 |
0.84 (0.66–1.07) 0.68 (0.49–0.94) |
0.69 0.57 |
| GISSI-Prevenzione Trial23 | 11 324men with recent (≤3 months prior) MI | 882 mg/day EPA+DHA versus usual care | 3.5 years | Cardiac deaths, n=520 Sudden deaths, n=286 |
0.78 (0.65–0.92) 0.74 (0.58–0.93) |
0.91 0.69 |
| DART 224 | 3114 men with angina | Advice to consume fatty fish 2 servings/week versus usual care | 3–9 years | Cardiac deaths, n=319 Sudden deaths, n=120 |
1.26 (1.00–1.58) 1.54 (1.06–2.23) |
0.65 0.26 |
| JELIS25 | 18 645men and women with total cholesterol ≥6.5 mmol/L | 1.8 g/day EPA versus usual care | 5 years | Major coronary events, n=586 Coronary deaths, n=60 Sudden deaths, n=35 |
0.81 (0.69–0.95) 0.94 (0.57–1.56) 1.06 (0.55–2.07) |
0.93 0.17 0.13 |
| GISSI-Heart Failure26 | 6975 patients with chronic congestive heart failure | 882 mg/day EPA+DHA versus placebo | 3.9 years | Total mortality, n=1969 Cardiovascular death, n=1477 Sudden deaths, n=632 |
0.91 (0.83–0.99) 0.90 (0.81–0.99) 0.93 (0.79–1.08) |
>0.99 >0.99 0.94 |
| Alpha Omega Trial27 | 4837 patients with a history of past (average ~4.3 years prior) MI | 376 mg/day EPA+DHA versus a combined control group receiving either placebo or ALA 1.9 g/day | 3.3 years | Major cardiovascular events, n=671 CHD deaths, n=138 |
1.01 (0.87–1.17) 0.98 (0.68–1.32) |
0.96 0.36 |
| OMEGA Trial28 | 3851 patients with recent (≤2 weeks prior) MI | 840 mg/day EPA+DHA versus placebo | 1 year | Major cardiovascular events, n=331 Sudden deaths, n=57 |
1.21 (0.96–1.52) 0.95 (0.56–1.60) |
0.72 0.17 |
| SU.FOL.OM329 2010 | 2501 patients with a history of past (average ~100 days prior) acute coronary or cerebral ischaemic event | 600 mg/day EPA+DHA versus a combined control group receiving either placebo or B vitamins (5-methyltetrahydrofolate, 560 μg; B6, 3 mg and B12, 20 μg) | 4.2 years | Major cardiovascular events, n=157 CHD deaths, n=40 |
1.08 (0.79–1.47) Not reported |
0.4 0.14 |
| ORIGIN14 | 12 536 patients at high risk for CVD and had IFG, IGT or diabetes | 900 mg/day EPA+DHA versus placebo | 6.2 years | CVD deaths, n=1155 Arrhythmia death‡, n=547 |
0.98 (0.87–1.10) 1.10 (0.93–1.30) |
>0.99 0.87 |
| Risk and prevention study2 | 12 513patients with multiple cardiovascular risk factors, or atherosclerotic vascular disease, but not MI | 850 mg/day EPA+DHA versus placebo | 5 years | CVD deaths, n=279 CHD deaths, n=158 |
1.03 (0.82, 1.30) 1.07 (0.78–1.46) |
0.61 0.38 |
Adapted from Mozaffarian and Wu.4
Based on the actual number of events, two-sided α=0.05, and a relative risk reduction of 25% for n-3 fatty acid treatment.
Sudden deaths, non-sudden deaths, unwitnessed deaths, resuscitation after cardiac arrest.
ALA, alpha-linolenic acid; CHD, coronary heart disease; CVD, cardiovascular disease; DART, Diet and Reinfarction Trial; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; IHD, ischemic heart disease; JELIS, Japan EPA Lipid Intervention Study, MI, myocardial infarction; ORIGIN, Outcome Reduction with an initial Glargine Intervention; SUFOLOM3, Supplementation en Folates et Omega-3.