Table 2.
Change in lipid parameters in patients with high and very high triglycerides with prescription omega-3 fatty acids
| Trial | Study description | Treatment | Patient characteristics | Results (mean change from baseline) | ||
|---|---|---|---|---|---|---|
| TG | LDL cholesterol | HDL cholesterol | ||||
| OM3EE | ||||||
| Harris [80] |
Double-blind, placebo-controlled 16 weeks |
OM3EE 4 g/day Placebo (corn oil) |
n = 42 TG: 500–2000 mg/dL Baseline TG: 877 mg/dL |
OM3EE: –45% Placebo: +16% (p < 0.0001) |
OM3EE: +32% Placebo: –5% (p = 0.0014) |
OM3EE: +13% Placebo: 0 (p < 0.014) |
| Pownall [81] | Double-blind, placebo-controlled 6 weeks |
OM3EE 4 g/day Placebo (corn oil) |
n = 41 TG: 500–2000 mg/dL Baseline TG: 801 mg/dL |
OM3EE: –39% Placebo: –8% (p = 0.001) |
OM3EE: +17% Placebo: –4% (p = 0.013) |
OM3EE: +6% Placebo: –6% (p = 0.023) |
| Davidson (COMBOS) [82] | Double-blind, placebo-controlled 8 weeks |
OM3EE 4 g/day Placebo (vegetable oil) |
n = 256 TG: 200–500 mg/dL on statin treatment (simvastatin 40 mg/day) Baseline TG: 282 mg/dL |
OM3EE: –28% Placebo: –4% (p < 0.001) |
OM3EE: +3% Placebo: –2% (p < 0.001) |
OM3EE: +4% Placebo: –1% (p < 0.001) |
| IPE | ||||||
| Bays (MARINE) [83] | Double-blind, placebo-controlled 12 weeks |
IPE 4 g/day IPE 2 g/day Placebo (light liquid paraffin) |
n = 229 TG 500–2000 mg/dL Baseline TG: 680 mg/dL |
IPE 2 g/day: –20% (placebo corrected) (p = 0.0051) IPE 4 g/day: –33% (placebo corrected) (p < 0.0001) |
IPE 2 g/day: +5% (placebo corrected) (p = 0.30) IPE 4 g/day: –2% (placebo corrected) (p = 0.68) |
IPE 2 g/day: +2% (placebo corrected) (p = 0.52) IPE 4 g/day: –4% (placebo corrected) (p = 0.22) |
| Ballantyne (ANCHOR) [84] | Double-blind, placebo-controlled 12 weeks |
IPE 4 g/day IPE 2 g/day Placebo (not specified) |
n = 663 TG ≥ 200 mg/dL on stable statin treatment with or without ezetimibe Baseline TG: 295 mg/dL |
IPE 2 g/day: –10% (placebo corrected) (p < 0.001) IPE 4 g/day: –22% (placebo corrected) (p < 0.0001) |
IPE 2 g/day: –4% (placebo corrected) (p = 0.087) IPE 4 g/day: –6% (placebo corrected) (p < 0.01) |
IPE 2 g/day: –2% (placebo corrected) (p = 0.13) IPE 4 g/day: –5% (placebo corrected) (p < 0.01) |
| OM3CA | ||||||
| Kastelein (EVOLVE) [85] | Double-blind, placebo controlled 12 weeks |
OM3CA 2 g/day OM3CA 3 g/day OM3CA 4 g/day Placebo (olive oil) |
n = 364 TG 500-2000 mg/dL untreated or on a stable dose of statin Baseline TG: 717 mg/dL (2 g/day group) 728 mg/dL (3 g/day group) 655 mg/dL (4 g/day group) |
OM3CA 2 g/day: –26% (p < 0.01) OM3CA 3 g/day: –26% (p < 0.01) OM3CA 4 g/day: –31% (p < 0.001) Placebo: –4% |
OM3CA 2 g/day: +19% (p < 0.01) OM3CA 3 g/day: +14% (p = NS) OM3CA 4 g/day: +19% (p < 0.001) Placebo: +3% |
OM3CA 2 g/day: +7% (p = NS) OM3CA 3 g/day: +4% (p = NS) OM3CA 4 g/day: +6% (p = NS) Placebo: +2% |
| Maki (ESPRIT) [86] | Double-blind, placebo controlled 6 weeks |
OM3CA 2 g/day OM3CA 4 g/day Placebo (olive oil) |
n = 627 TG 200–500 mg/dL on a maximally tolerated statin or statin with ezetimibe Baseline TG: 284 mg/dL (2 g/day group) 287 mg/dL (4 g/day group) |
OM3CA 2 g/day: –15% (p < 0.001) (non-HDL cholesterol: –4% (p < 0.05) OM3CA 4 g/day: –21% (p < 0.001) (non-HDL cholesterol: –7% (p < 0.001) Placebo: –6% |
OM3CA 2 g/day: +5% (p < 0.05) OM3CA 4 g/day: +1% (p = NS) Placebo: +1% |
OM3CA 2 g/day: +3% (p = NS) OM3CA 4 g/day: +3% (p = NS) Placebo: +2% |
p values refer to difference versus baseline
HDL high-density lipoprotein, IPE icosapent ethyl, LDL low-density lipoprotein, OM3CA omega-3 carboxylic acids, OM3EE omega-3 fatty acid ethyl esters, TG triglycerides