Table 2.
Responses to therapy.
| Treatment group | |||
|---|---|---|---|
| Placebo | 500 mg BID | 1000 mg BID | |
| Absolute change in LFC (%)* | |||
| N | 32 | 30 | 27 |
| Mean (SD) | −2.0 (4.88) | −2.9 (4.02) | −4.8 (4.35) |
| Min, max | −13.9, 6.3 | −11.5, 5.9 | −14.2, 2.9 |
| LS mean (SE) | −1.8 (0.74) | −3.2 (0.77) | −4.7 (0.81) |
| Difference in LS means (SE) vs. placebo | −1.4 (1.06) | −2.9 (1.10) | |
| p-value | 0.199 | 0.011 | |
| Relative change in LFC (%)** | |||
| N | 32 | 30 | 27 |
| Mean (SD) | −8.3 (24.48) | −15.1 (22.78) | −24.1 (21.70) |
| Min, max | −58.3, 46.6 | −66.4, 35.3 | −60.7, 22.1 |
| LS mean (SE) | −8.2 (4.09) | −15.9 (4.27) | −23.3 (4.53) |
| p-value | 0.196 | 0.016 | |
| Proportion achieving ≥5% absolute reduction in LFC**a | 8/33 (24%) | 10/31 (32%) | 12/30 (40%) |
| p-value (Chi squared test)–post hoc | 0.476 | 0.180 | |
| Proportion achieving ≥30% relative reduction in LFC**a | 7/33 (21%) | 6/31 (19%) | 10/30 (33%) |
| p-value (Chi squared test)–post hoc | 0.854 | 0.279 | |
| Mean change in HbA1c (%)** | |||
| N | 32 | 29 | 26 |
| Mean (SD) | 0.1 (0.82) | −0.3 (0.68) | −0.6 (0.96) |
| Min, max | −1.4, 2.7 | −1.8, 1.3 | −2.9, 1.6 |
| LS mean (SE) | 0.1 (0.14) | −0.4 (0.15) | −0.5 (0.16) |
| p-value | 0.029 | 0.005 | |
| Mean change in ALT (U/L)** | |||
| N | 32 | 29 | 26 |
| Mean (SD) | −3 (19.2) | −4 (17.9) | −19 (27.2) |
| Min, max | −50, 47 | −33, 52 | −89, 18 |
| LS mean (SE) | −2 (3.5) | −5 (3.7) | −16 (3.8) |
| p-value | 0.674 | 0.007 | |
| Mean change in GGT (U/L)** | |||
| N | 32 | 29 | 26 |
| Mean (SD) | −2 (34.9) | −19 (26.4) | −30 (47.9) |
| Min, max | −120, 124 | −104, 21 | −213, 18 |
| LS mean (SE) | −1 (4.6) | −20 (4.8) | −25 (5.0) |
| p-value | 0.005 | <0.001 | |
| Mean change in LDL-c (mg/dL)** | |||
| N | 29 | 27 | 25 |
| Mean (SD) | 0 (20.5) | 5 (34.1) | −16 (26.5) |
| Min, max | −54, 48 | −33, 147 | −103, 31 |
| LS mean (SE) | 1 (5.3) | 1 (5.4) | −12 (5.5) |
| p-value | 0.955 | 0.072 | |
| Mean change in triglycerides (mg/dL)** | |||
| N | 32 | 29 | 26 |
| Mean (SD) | 18 (142.9) | −41 (136.3) | −24 (70.4) |
| Min, max | −242, 632 | −710, 98 | −161, 154 |
| LS mean (SE) | 19 (18.5) | −36 (19.4) | −24 (20.4) |
| p-value | 0.041 | 0.120 | |
| Mean change in body weight (kg)*** | |||
| N | 32 | 29 | 27 |
| Mean (SD) | −1.1 (2.86) | −1.6 (3.02) | −3.5 (4.77) |
| Min, max | −9.1, 3.8 | −7.2, 5.9 | −18.9, 4.5 |
| LS mean (SE) | −1.1 (0.64) | −1.6 (0.67) | −3.5 (0.70) |
| p-value | 0.554 | 0.012 | |
Note: Unless indicated otherwise statistical tests are two-sided p-values and LS Means are obtained from an ANCOVA model with treatment group as a fixed effect, and Baseline value of associated parameters as covariates. Tests are 1000 mg or 500 mg vs. placebo.
aA placebo subject had data available at Week 18/ET but did not have baseline data, so they were not included in the absolute and relative change from baseline analyses in the Efficacy Set.
*Primary endpoint results for efficacy set.
**Modified efficacy set.
***Safety set.