Table 2.
Multivariate multinomial logistic regression for estimating the effects of time and treatment group on liver enzyme values†
| Characteristics | Adjusted‡ relative risk ratio Elevated: 1–3xULN (95% CI) |
P-value | Adjusted‡ relative risk ratio High: >3xULN (95% CI) |
P-value |
|---|---|---|---|---|
| AST | ||||
| Treatment arm: XR-NTX vs. placebo (referent) | 0.74 (0.37 to 1.45) |
0.38 | 0.25 (0.04 to 1.44) |
0.12 |
| Time (per month increase) | 1.27 (1.01 to 1.6) |
0.04 | 1.38 (0.97 to 1.97) |
0.07 |
| Typical daily alcohol consumption (per drink) | 1.03 (1.01 to 1.05) |
0.006 | 1.07 (1.04 to 1.09) |
< 0.001 |
| TimexTreatment arm | 0.83 (0.6 to 1.15) |
0.26 | 1.25 (0.71 to 2.19) |
0.44 |
| ALT | ||||
| Treatment arm: XR-NTX vs. placebo (referent) | 0.32 (0.12 to 0.83) |
0.02 | 0.57 (0.1 to 3.17) |
0.52 |
| Time (per month increase) | 1.06 (0.8 to 1.41) |
0.67 | 1.15 (0.66 to 2) |
0.61 |
| Typical daily alcohol consumption (per drink) | 1.04 (1.02 to 1.06) |
0.001 | 1.05 (1.02 to 1.08) |
0.001 |
| Time x Treatment arm | 1.09 (0.69 to 1.73) |
0.7 | 1 (0.47 to 2.11) |
1 |
| GGT | ||||
| Treatment arm: XR-NTX vs. placebo (referent) | 1.21 (0.53 to 2.72) |
0.65 | 0.56 (0.21 to 1.54) |
0.26 |
| Time (per month increase) | 1.29 (0.98 to 1.7) |
0.07 | 1.47 (1.17 to 1.83) |
0.001 |
| Typical daily alcohol consumption (per drink) | 1.03 (1 to 1.06) |
0.06 | 1.07 (1.04 to 1.09) |
<0.001 |
| Time x Treatment arm | 0.84 (0.61 to 1.16) |
0.3 | 0.84 (0.59 to 1.2) |
0.35 |
ALT: alanine aminotransferase. AST: aspartate aminotransferase. GGT: gamma glutamyl-transferase. XR-NTX: extended release naltrexone. ULN: upper limit of normal.
†
Liver enzyme value <1xULN (normal) is set as the referent group
‡
Adjusted for follow-up time, treatment arm, and typical daily alcohol consumption