Table 1. Past large-scale clinical studies of omega-3 PUFA.
| Study | GISSI-P | JELIS | GISSI-HF | ORIGIN | GISSI-R&P |
|---|---|---|---|---|---|
| CV event reduction | YES | YES | YES | NO | NO |
| Study period | 1993–1995 | 1994–2006 | 2002–2005 | 2003–2005 | 2004–2007 |
| Paper (year) | Lancet (1999)3) | Lancet (2007)48) | Lancet (2008)4) | NEJM (2012)21) | NEJM (2013)102) |
| Subject background | Prior MI (within 3 mo.) |
Hypercholesterole mia (> 250 mg/dl) (Primary 80.3%, secondary 19.7%) |
CHF | IGT/IFG/DM | Multiple CV risks |
| Baseline TG (mg/dL) | 162.1 | 154.2 | NA | ω: 142 c: 140 | ω: 150 c: 150 |
| Omega-3 preparation | EPA/DHA | EPA | EPA/DHA | EPA/DHA | EPA/DHA |
| Dosage (g/day) | 1 | 1.8 | 1 | 1 | 1 |
| No. of subjects | 11,324 | 18,645 | 7,046 | 12,612 | 12,513 |
| Follow-up (year) | 3.5 | 4.6 | 3.9 | 6.2 | 5 |
| Diabetes | NA | NA | NA | HbA1c (ω 6.4%: c 6.4%) |
NA |
| Statin use (%) | 29 | 100 | 23 | 54 | 62 |
| Use of ACE-I/ARB (%) | 41 | UN | 94 | 71 | 75 |
| Use of antiplatelets (%) | 88% | 14% | 87% | 79% | 60% |
| Event rate | 12.7% vs 14.1% | 2.8% vs 3.2% | 27% vs 29% | 9.1% vs 9.3% | 11.7% vs 11.9% |
| (ω vs c) | p < 0.05 | p = 0.011 | p = 0.041 | p = 0.72 | p = 0.58 |
CV: cardiovascular; MI: myocardial infarction; CHF: chronic heart failure; IGT: impaired glucose tolerance; IFG: impaired fasting glucose; DM: diabetes mellitus; EPA: eicosapentaenoic acid; DHA: docosahexaenoic acid; ω: omega-3, c: control; NA: not available.