Table 4.
Clinical Studies of Lovaza and Vascepa in Statin-Treated Patients with High Triglyceride Levels
| Lovaza (Omega-3-Acid Ethyl Esters)59 | Vascepa (Icosapent Ethyl)50 | |||||||
|---|---|---|---|---|---|---|---|---|
| Study | COMBOS37 (N = 256) | ANCHOR50 (N = 702) | ||||||
| Lipid and statin inclusion criteria | TG ≥ 200 and <500 mg/dL; mean LDL-C ≤ 10% above NCEP ATP III goal | TG ≥ 200 and <500 mg/dL; LDL-C ≥40 and <115 mg/dL with optimized statin therapy | ||||||
| Duration | 8 weeks | 12 weeks | ||||||
| Treatment | 4 g/day plus simvastatin 40 mg/day (n = 122) | Placebo plus simvastatin 40 mg/day (n = 132) | 4 g/day plus statina (n = 226) | Placebo plus statina (n = 227) | ||||
| BL | % Chgb | BL | % Chgb | BL | % Chgb | BL | % Chgb | |
| TG (mg/dL) | 268 | −29.5 | 271 | −6.3 | 265 | −17.5 | 259 | 5.9 |
| Difference, Pc | −23.2, P < 0.0001 | −21.5, P < 0.0001 | ||||||
| LDL-C (mg/dL) | 91 | 0.7 | 88 | −2.8 | 82 | 1.5 | 84 | 8.8 |
| Difference, P | 3.5, P = 0.05 | −6.2, P = 0.007 | ||||||
| Non–HDL-C (mg/dL) | 137 | −9.0 | 141 | −2.2 | 128 | −5.0 | 128 | 9.8 |
| Difference, P | −6.8, P < 0.0001 | −13.6, P < 0.0001 | ||||||
| TC (mg/dL) | 184 | −4.8 | 184 | −1.7 | 167 | −3.2 | 168 | 9.1 |
| Difference, P | −3.1, P < 0.05 | −12.0, P < 0.0001 | ||||||
| HDL-C (mg/dL) | 46 | +3.4 | 43 | −1.2 | 37 | −1.0 | 39 | 4.8 |
| Difference, P | +4.6, P < 0.05 | −4.5, P = 0.0013 | ||||||
| VLDL-C (mg/dL) | 52 | −27.5 | 52 | −7.2 | 44 | −12.1 | 42 | 15 |
| Difference, P | −20.3, P < 0.05 | −24.4, P < 0.0001 | ||||||
| Apo B (mg/dL) | 86 | −4.2 | 87 | −1.9 | 93 | −2.2 | 91 | 7.1 |
| Difference, P | −2.3, P < 0.05 | −9.3, P < 0.0001 | ||||||
Various regimens (and patient numbers) of simvastatin, atorvastatin, or rosuvastatin.
% Chg = median percentage change from baseline.
Difference for omega-3 acid ethyl esters: omega-3 acid ethyl esters median % change minus placebo median % change. Difference for icosapent ethyl: median of (icosapent ethyl % change – placebo % change) (Hodges-Lehmann estimate; two-tailed 95% confidence interval).
ANCHOR = Effect of AMR101 (Ethyl Icosapentate) on Triglyceride Levels in Patients on Statins With High Triglyceride Levels (≥ 200 and < 500 mg/dL); Apo B = apolipoprotein B; COMBOS = Combination of Prescription Omega-3 With Simvastatin; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol; NCEP–ATP III = National Cholesterol Education Program–Adult Treatment Panel III; non–HDL-C = non–high-density lipoprotein-cholesterol; TC = total cholesterol; TG = triglyceride; VLDL-C = very-low-density lipoprotein-cholesterol.