Table 3.
Estimated Mean Reductions in Serum Liver Tests, Stratified by Clinical Trial (POISE) Inclusion Criteria
| ALP | POISE Eligible (n = 44) | Outside POISE Criteria (n = 19) | ||||||
|---|---|---|---|---|---|---|---|---|
| Duration of OCA (Months) | ALP (U/L) | Reduction (U/L) | P value | Duration of OCA (Months) | ALP (U/L) | Reduction (U/L) | P value | |
| 0 | 327 | – | – | 0 | 180 | – | – | |
| 12 | 257 | 70 | P < 0.01 | 12 | 146 | 34 | P < 0.01 | |
| ALT | Duration of OCA (Months) | ALT (U/L) | Reduction (U/L) | P value | Duration of OCA (Months) | ALT (U/L) | Reduction (U/L) | P value |
|---|---|---|---|---|---|---|---|---|
| 0 | 43.7 | – | – | 0 | 39.7 | – | – | |
| 12 | 32.7 | 11.0 | P < 0.01 | 12 | 34.4 | 5.3 | P = 0.21 |
| AST | Duration of OCA (Months) | AST (U/L) | Reduction (U/L) | P value | Duration of OCA (Months) | AST (U/L) | Reduction (U/L) | P value |
|---|---|---|---|---|---|---|---|---|
| 0 | 46.8 | – | – | 0 | 42.5 | – | – | |
| 12 | 40.8 | 6.0 | P = 0.09 | 12 | 39.9 | 2.6 | P = 0.46 |
| IgM | Duration of OCA (Months) | IgM (g/L) | Reduction (g/L) | P value | Duration of OCA (Months) | IgM (g/L) | Reduction (g/L) | P value |
|---|---|---|---|---|---|---|---|---|
| 0 | 3.20 | – | – | 0 | 2.49 | – | – | |
| 12 | 2.39 | 0.81 | P < 0.01 | 12 | 2.06 | 0.43 | P = 0.07 |
| GGT | Duration of OCA (Months) | GGT (U/L) | Reduction (U/L) | P value | Duration of OCA (Months) | GGT (U/L) | Reduction (U/L) | P value |
|---|---|---|---|---|---|---|---|---|
| 0 | 256 | – | – | 0 | 162 | – | – | |
| 12 | 106 | 150 | P < 0.01 | 12 | 63 | 99 | P < 0.01 |
Estimates obtained through linear mixed‐effects regression.