Table 6.
Clinical Laboratory and Lipid Parameters at Baseline and on Day 8 (After the Main Study Phase): Intention-to-Treat Population
| Baseline |
Day 8 |
Pa |
Pb |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Test Group (SMOFlipid) | n | Control Group | n | Test Group (SMOFlipid) | n | Control Group | Test vs Control | Test Group (SMOFlipid) | Control Group | |
| Hemoglobin, g/dLc | 25 | 13.0 (1.87) | 24 | 12.9 (2.08) | 12 | 11.8 (2.02) | 13 | 12.1 (2.16) | .276 | .001 | .002 |
| Hematocrit, %c | 25 | 36.6 (4.79) | 24 | 36.4 (5.22) | 12 | 33.5 (5.56) | 13 | 34.9 (5.94) | .468 | .003 | .002 |
| Red blood cells, 1012/Lc | 25 | 3.7 (0.51) | 24 | 3.6 (0.52) | 12 | 3.4 (0.53) | 13 | 3.5 (0.50) | .235 | .003 | .002 |
| White blood cells, 109/Lc | 25 | 14.6 (5.16) | 24 | 12.0 (3.18) | 12 | 12.7 (2.43) | 13 | 9.8 (3.14) | .176 | .029 | .322 |
| Platelets, 109/Lc | 25 | 406.2 (133.27) | 24 | 370.5 (144.75) | 12 | 477.1 (116.49) | 13 | 454.5 (176.65) | .817 | .007 | .084 |
| ALT, IU/L | 25 | 6.0 (1.57) | 25 | 6.4 (1.64) | 21 | 9.8 (4.83) | 21 | 9.2 (4.11) | .888 | .003 | .008 |
| GGT, IU/L | 24 | 89.8 (55.37) | 19 | 71.0 (47.42) | 21 | 73.1 (33.99) | 18 | 63.0 (44.30) | .135 | .126 | .465 |
| Direct bilirubin | 19 | 22 | 19 | 22 | .036 | .347 | .022 | ||||
| µmol/Lc, d | 12.48 (7.2) | 8.04 (5.6) | 10.26 (5.8) | 12.83 (7.2) | |||||||
| mg/dL | 0.73 (0.42) | 0.47 (0.33) | 0.6 (0.34) | 0.75 (0.42) | |||||||
| Total bilirubin | 26 | 27 | 19 | 24 | .049 | <.001 | .137 | ||||
| µmol/Lc, d | 127.6 (70.82) | 115 (47.26) | 94.8 (68.18) | 98.2 (74.69) | |||||||
| mg/dL | 7.46 (4.14) | 6.73 (2.76) | 5.54 (3.99) | 5.74 (4.37) | |||||||
| Creatininee | 25 | 70.9 (12.36) | 26 | 70.7 (10.45) | 16 | 63.3 (4.83) | 13 | 67.3 (8.09) | .614 | .003 | .003 |
| CRP, mg/L | 26 | 1.4 (1.09) | 27 | 2.0 (3.42) | 21 | 2.3 (5.89) | 22 | 9.2 (37.90) | .965 | .438 | .234 |
| Glucose, mmol/L | 25 | 5.4 (2.80) | 25 | 4.8 (0.94) | 23 | 5.0 (0.88) | 22 | 4.9 (0.88) | .827 | .571 | .480 |
| Serum triglycerides | 26 | 23 | 20 | 22 | .781 | .027 | .072 | ||||
| mmol/L | 0.52 (0.16) | 0.54 (0.19) | 0.69 (0.38) | 0.67 (0.36) | |||||||
| mg/dL | 46.02 (14.16) | 47.79 (16.81) | 61.06 (35.40) | 59.29 (30.10) | |||||||
| Total cholesterol, mmol/L | 26 | 3.1 (0.91) | 22 | 3.1 (0.90) | 12 | 3.9 (0.86) | 13 | 3.0 (0.74)f | .060 | .034 | .652 |
| Ratio LDL/HDL cholesterol, g/cm (IU/L) | 24 | 1.22 (0.59) | 22 | 1.18 (0.54) | 12 | 1.89 (0.68) | 13 | 1.48 (0.64) | .160 | .014 | .820 |
| HDL cholesterol, mmol/L | 25 | 1.4 (0.51) | 23 | 1.4 (0.44) | 12 | 1.3 (0.25) | 13 | 1.1 (0.28) | .742 | .182 | .232 |
| LDL cholesterol, mmol/L | 24 | 1.5 (0.70) | 22 | 1.5 (0.61) | 12 | 2.3 (0.73) | 13 | 1.6 (0.64) | .080 | .040 | 1.000 |
Values presented as mean (SD). All comparisons of change from baseline (within and between groups) are based on patients with pairwise available data. ALT, alanine 3aminotransferase; CRP, C-reactive protein; GGT, glutamyl transpeptidase; HDL, high-density lipoprotein; LDL, low-density lipoprotein.
a
Between-groups comparison of change from baseline, Wilcoxon test.
b
Within-groups comparison (baseline vs day 8), Wilcoxon signed rank test.
c
Baseline value = day 3.
e
Baseline value = day 5.
d
Final value = last visit.
f
Between-groups comparison on day 8, P < .05.