Table 2 Primary endpoint: alteration in triglyceride (TG) levels from baseline to week 12 (modified intent-to-treat population)
Characteristics | IPE 4 g/day (n = 125) | IPE 2 g/day (n = 124) | Placebo (n = 124) | Placebo-corrected median TG Change from baseline | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Â | Baseline TG (mmol/L) | End-of-treatment TG (mmol/L) | Change from baseline (%) | Baseline TG (mmol/L) | End-of-treatment TG (mmol/L) | Change from baseline (%) | Baseline TG (mmol/L) | End-of-treatment TG (mmol/L) | Change from baseline (%) | IPE 4Â g/day vs. placebo (%, P value) | IPE 2Â g/day vs. placebo (%, P value) |
Intent-to-treat population (n = 122, 124, 123) | 9.455 (5.910) | 6.145 (5.370) |  − 28.35 (56.40) | 9.215 (6.410) | 7.720 (7.055) |  − 11.95 (63.85) | 9.170 (5.580) | 8.290 (6.070) |  − 6.20 (67.40) |  − 19.90, < 0.001 |  − 5.00, 0.361 |
Baseline TG ≤ 8.5 mmol/L (n = 58, 56, 57) | 7.145 (3.380) | 5.320 (2.170) |  − 29.40 (40.90) | 6.900 (3.165) | 6.010 (4.150) |  − 1.200 (59.45) | 6.860 (3.290) | 6.760 (4.020) | 0.50 (58.00) |  − 25.95, < 0.001 |  − 5.90, 0.570 |
Baseline T  > 8.5 mmol/L (n = 64, 68, 66) | 11.715 (5.870) | 8.700 (6.550) |  − 27.60 (64.80) | 11.430 (5.725) | 9.625 (6.675) |  − 17.70 (66.45) | 11.415 (4.610) | 10.505 (7.190) |  − 17.80 (77.00) |  − 15.30, 0.030 |  − 4.75, 0.509 |
Male (n = 90, 93, 94) | 9.575 (5.710) | 6.340 (5.880) |  − 27.15 (56.40) | 9.090 (5.470) | 7.240 (7.010) |  − 8.40 (65.60) | 9.065 (4.980) | 8.780 (5.710) |  − 5.00 (69.60) |  − 19.95, 0.002 |  − 4.65, 0.511 |
Female (n = 32, 31, 29) | 7.965 (5.635) | 4.820 (4.120) |  − 34.70 (53.20) | 10.860 (7.260) | 8.300 (6.410) |  − 13.20 (44.20) | 9.740 (6.510) | 6.970 (6.510) |  − 13.30 (62.10) |  − 20.35, 0.034 |  − 7.75, 0.506 |
Statin use at baseline (n = 13, 13, 13) | 8.610 (5.480) | 6.460 (4.600) |  − 13.10 (37.20) | 13.720 (7.240) | 9.360 (8.430) |  − 9.20 (75.50) | 9.170 (6.250) | 10.390 (4.020) |  − 17.70 (66.70) |  − 9.15, 0.739 |  − 8.20, 0.505 |
No statin use at baseline (n = 109, 111, 110) | 9.470 (5.740) | 6.120 (5.370) |  − 29.40 (59.10) | 9.010 (5.690) | 7.220 (7.050) |  − 12.00 (64.10) | 9.245 (5.080) | 8.075 (6.130) |  − 5.85 (66.10) |  − 21.45, < 0.001 |  − 4.60, 0.439 |