Table 3.
Pivotal Studies of Lovaza and Vascepa for the Treatment of Very High Triglyceride Levels
| Lovaza (Omega-3-Acid Ethyl Esters)59 | Vascepa (Icosapent Ethyl)63 | |||||||
|---|---|---|---|---|---|---|---|---|
| Study | Two studies35,60 | MARINE49 | ||||||
| Lipid inclusion criteria | TG ≥ 500 and ≤2,000 mg/dL | TG ≥ 500 and ≤2,000 mg/dL | ||||||
| Duration | 6 and 16 weeks | 12 weeks | ||||||
| 4 g/day (n = 42) | Placebo (n = 42) | 4 g/day (n = 76) | Placebo (n = 75) | |||||
| BL | % Chga | BL | % Chga | BL | % Chga | BL | % Chga | |
| TG (mg/dL) | 816 | −44.9 | 788 | +6.7 | 680 | −26.6 | 703 | +9.7 |
| Differenceb | −51.6 | −33.1c (−47, −22) | ||||||
| LDL-C (mg/dL) | 89 | +44.5 | 108 | −4.8 | 91 | −4.5 | 86 | −3.0 |
| Difference | +49.3 | −2.3 (−13, +8) | ||||||
| Non–HDL-C (mg/dL) | 271 | −13.8 | 292 | −3.6 | 225 | −7.7 | 229 | +7.8 |
| Difference | −10.2 | −17.7 (−25, −11) | ||||||
| TC (mg/dL) | 296 | −9.7 | 314 | −1.7 | 254 | −7.3 | 256 | +7.7 |
| Difference | −8.0 | −16.3 (−22, −11) | ||||||
| HDL-C (mg/dL) | 22 | +9.1 | 24 | 0.0 | 27 | −3.5 | 27 | 0 |
| Difference | +9.1 | −3.6 (−9, +2) | ||||||
| VLDL-C (mg/dL) | 175 | −41.7 | 175 | −0.9 | 123 | −19.5 | 124 | +13.7 |
| Difference | −40.8 | −28.6d (−43, −14) | ||||||
| Apo B (mg/dL) | — | — | — | — | 121 | −3.8 | 118 | +4.3 |
| Difference | — | −8.5d (−14, −3) | ||||||
% Chg = median percentage change from baseline.
Difference for omega-3 acid ethyl esters: omega-3 acid ethyl esters median % change – placebo median % change. Difference for icosapent ethyl: median of (icosapent ethyl % change – placebo % change) (Hodges–Lehmann estimate, 95% confidence intervals)
P < 0.001 (Wilcoxon rank-sum test; primary efficacy endpoint).
P < 0.05 (Wilcoxon rank-sum test; key secondary endpoints determined to be statistically significant according to prespecified multiple comparison procedure).
Apo B = apolipoprotein B; BL = baseline; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol; MARINE = Multicenter, Placebo-controlled, Randomized, Double-blind, 12-week Study With an Open-label Extension; non–HDL-C = non-high-density lipoprotein-cholesterol; TC = total cholesterol; TG = triglyceride; VLDL-C = very-low-density lipoprotein-cholesterol.