Table 3.
Comparison of NAFLD Patients Who Had Decrease versus Increase in Their Fat Fraction by MRI-PDFF and MRS Between Week 0 and Week 24
| MRI-PDFF Liver Fat Change Between Enrollment and Week 24 (After Treatment or Placebo)
|
MRS Liver Fat Change Between Enrollment and Week 24 (After Treatment or Placebo)
|
|||||
|---|---|---|---|---|---|---|
| MRI-PDFF Decreased ≥1% (n=16) | Fat Fraction Increased ≥ 1% (n=17) | P Value | Fat Fraction Decreased ≥1% (n=14) | Fat Fraction Increased ≥1% (n=17) | P Value | |
| Body weight changes | ||||||
| Weight (Kg) (CI) | −2.0 (−3.3,−0.6) | 0.3 (−0.9,1.6) | 0.008 | −1.83 (−3.3,−0.3) | 0.4 (−1.2,2.1) | 0.0137 |
| Laboratory changes | ||||||
| ALT (U/L) (CI) | −23.5 (−51.7,4.7) | 31.8 (11.8, 51.8) | 0.0008 | −9.2 (−42.0,13.0) | 32.6 (7.8, 57.5) | 0.0083 |
| AST (U/L) (CI) | −16.8 (−42.8,9.2) | 13.9 (1.4,26.4) | 0.0018 | −3.3 (−11.0,4.3) | 14.6 (−1.5, 30.8) | 0.0131 |
| GGT (U/L) (CI) | −4.2 (−12.7,4.4) | 31.8 (4.3,59.2) | 0.02 | 3.3 (−14.2,20.7) | 36.13 (1.2, 71.1) | 0.088 |
| Histology changes | ||||||
| Steatosis (CI) | −0.8 (−1.2,−0.3) | −0.14 (0.5, −0.4.02) | 0.02 | −0.8 (−1.3,−0.3) | −0.2 (−0.5,0.2) | 0.06 |
| Lobular inflammation (CI) | 0.2 (−0.2,0.6) | −0.08 (−0.5,0.4) | 0.4 | 0.2 (−0.3,0.7) | 0.0 (−0.4,0.4) | 0.5 |
| Ballooning (CI) | 0.0 (−0.5,0.5) | 0.08 (−0.4,0.6) | 0.97 | 0.2 (−0.2,0.7) | 0.3 (−0.3,0.9) | 1 |
| NAS (CI) | −0.6 (−1.7,0.5) | −0.17 (−1.3,1.0) | 0.6 | −0.3 (−1.6,0.9) | 0.1 (−1.1,1.3) | 0.6 |
| Fibrosis (CI) | 0.2 (−0.7,1,1) | −0.08 (−0.5,0.3) | 0.6 | 0 (−1.0,1.0) | 0 (−0.5,0.5) | 0.8 |
Decrease in liver fat of ≥1% by MRI-PDFF is associated with weight loss and decrease in serum ALT, AST, and GGT. Similarly, an increase in liver fat of ≥1% by MRI-PDFF is associated with weight gain and increase in serum ALT, AST, and GGT. Although MRI-PDFF is sensitive in capturing these dynamic changes in weight and serum liver enzymes over a 24-week period, liver biopsy determined steatosis grade (because of its subjective assessment) is not able to show a significant change.
Data are expressed as means with confidence intervals (CI) in parentheses or mean difference.
Independent sample t test assuming equal variance was performed on all continuous variables for comparisons between groups. Mean differences reflect comparison between posttreatment averages minus baseline averages.