Table.
Clinical Trials on n-3 PUFA and Cardiovascular Events
| Clinical trial (publication year) |
No. patients |
n-3 PUFA dose | Primary endpoint | Clinical outcome |
RR or HR |
|---|---|---|---|---|---|
| GISSI-Prevenzione Trial (1999)3 |
11,334 | EPA+DHA (850–882 mg/day) |
(a) Death, non-fatal MI, and non-fatal stroke (b) Cardiovascular death, non-fatal MI, and non-fatal stroke |
Positive | Four-way analysis (a) RR, 0.85 (95% CI: 0.74–0.98) (b) RR, 0.80 (95% CI: 0.68–0.95) |
| JELIS (2007)4 | 18,645 | EPA (1,800 mg/day) |
Any major coronary event, including sudden cardiac death, fatal and non-fatal MI, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or CABG |
Positive | HR, 0.81 (95% CI: 0.69–0.95) |
| ORIGIN (2012)6 | 12,536 | EPA+DHA (840 mg/day) |
Death from cardiovascular causes | Negative | HR, 0.98 (95% CI: 0.87–1.10) |
| Risk and Prevention Study (2013)7 |
12,505 | EPA+DHA (850–1,000 mg/day) |
Cumulative rate of death, non-fatal MI, and non-fatal stroke |
Negative | HR, 0.97 (95% CI: 0.88–1.08) |
| ASCEND (2018)8 | 15,480 | EPA+DHA (840 mg/day) |
First serious vascular event (i.e., non-fatal MI, or stroke, TIA, or vascular death, excluding confirmed intracranial hemorrhage) |
Negative | Rate ratio, 0.97 (95% CI: 0.87–1.08) |
| REDUCE-IT (2019)5 | 8,179 | EPA (4,000 mg/day) |
Composite of cardiovascular death, non-fatal MI (including silent MI), non-fatal stroke, coronary revascularization, or unstable angina |
Positive | HR, 0.75 (95% CI: 0.68–0.83) |
| VITAL (2019)9 | 25,871 | EPA+DHA (840 mg/day) |
Major cardiovascular events (a composite of MI, stroke, or death from cardiovascular causes) and invasive cancer of any type |
Negative | HR, 0.92 (95% CI: 0.80–1.06) |
ASCEND, A Study of Cardiovascular Events in Diabetes; CABG, coronary artery bypass grafting; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; GISSI-Prevenzione, Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico-Prevenzione; JELIS, Japan EPA Lipid intervention Study; MI, myocardial infarction; ORIGIN, Outcome Reduction with an Initial Glargine Intervention; PUFA, polyunsaturated fatty acid; REDUCE-IT, Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia; RR, relative risk; TIA, transient ischemic attack; VITAL, Vitamin D and Omega-3 Trial.