Table 2.
Summary of primary and secondary endpoint measures
| Placebo | 6:1-OM3 | Placebo-adjusted % change from baseline | ||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Week 8 | % Change baseline-week 8 | Baseline | Week 8 | % Change from baseline | Placebo versus 6:1-OM3 | P | |
| Cohort 1 | ||||||||
| Primary end point | ||||||||
| Omega-score (n = 32, 32, 36, 36) | 3.38 (1.29) | 3.60 (1.03) | 0.3 (27.8) | 3.64 (1.38) | 7.83 (2.77) | 132.2 (101.3) | 131.9 | <0.0001 |
| Omega-3 index (n = 32, 32, 36, 36) | 3.56 (1.26) | 3.61 (1.11) | 3.2 (28.5) | 3.81 (1.31) | 7.83 (2.58) | 127.3 (82.5) | 124.1 | <0.0001 |
| Secondary end points | ||||||||
| TG (mmol/L) (n = 32, 32, 36, 36) | 1.48 (0.58) | 1.59 (1.12) | 2.0 (34.0) | 1.75 (0.84) | 1.54 (0.63) | −6.0 (27.3) | −8.0 | 0.11 |
| Total Cholesterol (mmol/L) (n = 32, 32, 36, 36) | 4.65 (1.03) | 4.75 (1.51) | 2.2 (11.5) | 4.84 (1.24) | 5.07 (1.12) | 2.3 (17.8) | 0.1 | 0.50 |
| VLDL-C (mmol/L) (n = 32, 32, 36, 36) | 0.69 (0.21) | 0.65 (0.27) | 0.0 (22.2) | 0.66 (0.26) | 0.67 (0.23) | −1.9 (28.3) | −1.9 | 0.34 |
| IDL-C (mmol/L) (n = 32, 32, 36, 36) | 0.39 (0.14) | 0.36 (0.21) | −9.3 (31.8) | 0.45 (0.22) | 0.40 (0.24) | −6.4 (43.4) | 3.0 | 0.54 |
| LDL-C (mmol/L) (n = 32, 32, 36, 36) | 2.67 (0.72) | 2.67 (1.03) | 1.4 (17.2) | 2.99 (1.16) | 3.32 (1.08) | 7.0 (25.9) | 5.6 | 0.12 |
| HDL-C (mmol/L) (n = 32, 32, 36, 36) | 1.18 (0.42) | 1.15 (0.42) | 0.0 (14.1) | 1.06 (0.27) | 1.09 (0.26) | −2.2 (13.5) | −2.2 | 0.42 |
| NHDL-C (mmol/L) (n = 32, 32, 36, 36) | 3.22 (0.96) | 3.30 (1.19) | 3.2 (14.9) | 3.74 (1.23) | 4.10 (1.04) | 2.5 (21.5) | −0.8 | 0.22 |
| Blood glucose (mmol/L) (n = 23, 23, 27, 27) | 5.10 (1.30) | 5.60 (1.70) | −3.9 (36.4) | 5.30 (1.10) | 5.40 (1.00) | 4.3 (24.4) | 8.1 | 0.89 |
| AA:EPA (n = 32, 32, 36, 36) | 21.00 (11.80) | 24.00 (13.50) | 7.0 (45.8) | 21.20 (13.40) | 3.00 (2.30) | −85.6 (20.1) | −93.0 | <0.0001 |
| n-6:n-3 (n = 32, 32, 36, 36) | 9.70 (2.3) | 9.80 (2.60) | 3.6 (29.5) | 9.60 (2.90) | 4.60 (1.60) | −52.2 (17.9) | −48.6 | <0.0001 |
| hs-CRP (mg/L) (n = 32, 32, 36, 36) | 3.40 (7.4) | 1.90 (5.40) | −2.7 (58.4) | 2.40 (4.20) | 2.20 (4.40) | 0.0 (73.3) | 2.7 | 0.23 |
| Apo-B (g/L) (n = 32, 32, 36, 36) | 0.90 (0.18) | 0.92 (0.29) | 2.5 (13.2) | 1.02 (0.25) | 1.08 (0.31) | 5.8 (17.7) | 3.3 | 0.32 |
| Apo-A (g/L) (n = 32, 32, 36, 36) | 1.38 (0.27) | 1.37 (0.33) | 1.5 (8.1) | 1.32 (0.18) | 1.32 (0.17) | −2.0 (9.1) | −3.4 | 0.14 |
| Apo-B:Apo-A (n = 32, 32, 36, 36) | 0.70 (0.20) | 0.60 (0.20) | −0.7 (18.3) | 0.80 (0.20) | 0.80 (0.30) | 6.5 (19.1) | 7.2 | 0.11 |
| Cohort 2 | ||||||||
| Primary end point | ||||||||
| Omega-score (n = 22, 22, 20, 20) | 3.36 (1. 61) | 3.43 (1.09) | −2.0 (32.2) | 3.15 (0.90) | 6.78 (4.30) | 118.9 (114.4) | 120.9 | <0.0001 |
| Omega-3 index (n = 22, 22, 20, 20) | 3.54 (1.53) | 3.61 (1.27) | −2.9 (26.5) | 3.34 (0.89) | 6.80 (4.60) | 109.1 (97.7) | 112.0 | <0.0001 |
| Secondary end points | ||||||||
| TG (mmol/L) (n = 22, 22, 20, 20) | 2.98 (0.72) | 2.99 (1.41) | 0.4 (45.0) | 3.10 (1.31) | 2.03 (1.53) | −47.4 (27.6) | −47.8 | 0.0005 |
| Total Cholesterol (mmol/L) (n = 21, 21, 20, 20) | 4.82 (1.32) | 4.63 (1.19) | 2.9 (10.7) | 4.79 (1.72) | 5.14 (1.85) | 4.4 (11.3) | 1.5 | 0.36 |
| VLDL-C (mmol/L) (n = 22, 22, 20, 20) | 0.93 (0.27) | 0.92 (0.18) | 0.0 (17.4) | 1.05 (0.44) | 0.75 (0.32) | −30.2 (26.4) | −30.2 | 0.0023 |
| IDL-C (mmol/L) (n = 21, 21, 20, 20) | 0.47 (0.18) | 0.47 (0.18) | 0.0 (27.9) | 0.49 (0.27) | 0.51 (0.33) | 0.0 (28.0) | 0.0 | 0.87 |
| LDL-C (mmol/L) (n = 22, 22, 20, 20) | 2.64 (0.78) | 2.69 (0.85) | 1.7 (21.8) | 2.97 (1.64) | 3.38 (1.45) | 13.0 (21.5) | 11.3 | 0.12 |
| HDL-C (mmol/L) (n = 22, 21, 20, 20) | 1.01 (0.30) | 0.96 (0.32) | −5.7 (12.1) | 1.01 (0.37) | 1.01 (0.31) | 3.4 (24.7) | 9.1 | 0.0069 |
| NHDL-C (mmol/L) (n = 21, 21, 20, 20) | 3.70 (1.10) | 3.81 (1.05) | 3.7 (13.1) | 3.82 (1.84) | 4.03 (2.02) | 1.5 (13.5) | −2.2 | 0.68 |
| Blood glucose (mmol/L) (n = 14, 14, 10, 11) | 5.60 (3.00) | 5.60 (2.40) | −4.7 (12.2) | 5.40 (2.00) | 5.60 (0.8) | 4.3 (22.3) | 8.9 | 0.23 |
| AA:EPA (n = 22, 22, 20, 20) | 15.00 (7.10) | 14.10 (6.30) | 11.3 (25.5) | 16.00 (12.80) | 3.50 (5.80) | −75.0 (23.0) | −87.0 | <0.0001 |
| n-6:n-3 (n = 22, 22, 20, 20) | 9.30 (3.30) | 9.04 (1.70) | 2.3 (35.3) | 9.10 (2.90) | 5.10 (2.90) | −43.3 (27.8) | −45.5 | <0.0001 |
| hs-CRP (mg/L) (n = 22, 22, 20, 20) | 3.40 (4.00) | 3.30 (2.80) | 4.8 (76.3) | 1.60 (5.70) | 1.90 (4.50) | 3.6 (33.0) | −1.3 | 0.97 |
| Apo-B (g/L) (n = 22, 20, 20, 20) | 1.00 (0.22) | 0.99 (0.25) | 1.7 (13.9) | 1.05 (0.40) | 1.08 (0.45) | −0.4 (14.8) | −2.1 | 0.74 |
| Apo-A (g/L) (n = 21, 20, 20, 20) | 1.33 (0.18) | 1.31 (0.19) | −1.4 (7.3) | 1.35 (0.34) | 1.38 (0.29) | −2.4 (12.3) | −1.0 | 0.58 |
| Apo-B:Apo-A (n = 22, 20, 20, 20) | 0.70 (0.20) | 0.70 (0.20) | 1.4 (11.3) | 0.80 (0.20) | 0.80 (0.30) | 3.2 (15.6) | 1.8 | 0.96 |
Data are presented as median (interquartile range)