Table 1.
Overview of the randomized clinical studies evaluating omega-3 PUFAs.
| Trial | Patient characteristics | No. of participants | Daily PUFA dose | Outcomes |
|---|---|---|---|---|
| Positive studies | ||||
| DART3 | Men after myocardial infarction | 2,033 | 350 EPA | Treatment was associated with a 29% reduction in total mortality (P < 0.05) |
| GISSI-Prevenzione4 | Men and women (15%) after myocardial infarction | 11,324 | 850 mg EPA/DHA | The group treated with omega-3 PUFAs were shown to have a 20% reduction in major CV events (P = 0.008), a 30% reduction of CV death (P = 0.02), and a 45% reduction in SCD (P = 0.01) |
| JELIS5 | Hypercholesterolemic men and women (69%), with and without CHD, already receiving statin therapy | 18,645 | 1,800 mg EPA | Treatment was associated with a 19% reduction in major CV events (P = 0.01) |
| GISSI-HF6 | Men and women (22%) with congestive heart failure | 6,975 | 850 mg EPA/DHA | Treatment was associated with a 6% reduction in CV death or hospitalization (P = 0.04) |
| Negative studies | ||||
| DART-211 | Men with angina | 3,114 | 430 mg EPA | Treatment was associated with increased risk for cardiac death (HR 1.26; P < 0.05) and sudden cardiac death (HR 1.54; P < 0.03) |
| Alpha-Omega12,21 | Men and women (22%) after myocardial infarction | 4,837 | 400 mg EPA/DHA | There was no general benefit to treatment, however there was a reduction in CV events, CHD death and arrhythmias in diabetics receiving omega-3 PUFAs (HR 0.65, 0.51, and 0.51 respectively) |
| OMEGA13 | Men and women (26%) after myocardial infarction | 3,851 | 840 mg EPA/DHA | Omega-3 PUFA supplementation showed no reduction in mortality, MCE, or SCD in the treated group |
| SU.FOL.OM314 | Men and women (20%) after myocardial infarction | 2,501 | 600 mg EPA/DHA | Treatment with PUFAs was not associated with a reduction in mortality or MCE |
| ORIGIN15 | Dysglycemic men and women (35%) with and without CHD | 12,536 | 840 mg EPA/DHA | Treatment with PUFAs failed to demonstrate a reduction in mortality, MCE, or SCD. |
Abbreviations: CHD, coronary artery disease; CV, cardiovascular; EPA, eicosapentanaenoic acid; DHA, docosahexaenoic acid; HR, hazard ratio; MCE, major cardiovascular event; PUFA, polyunsaturated fatty acid; SCD, sudden cardiac death.