Table 3.
Changes in safety parameters
| Parameter | n | Baseline | LOCF | p-value |
|---|---|---|---|---|
| Body mass index (kg/m2) |
362 |
25.49 ± 3.72 |
25.40 ± 3.77 |
0.087 |
| Total bilirubin (mg/dL) |
292 |
0.64 ± 0.25 |
0.58 ± 0.22 |
<0.001 |
| Creatinine (mg/dL) |
449 |
0.76 ± 0.17 |
0.78 ± 0.19 |
<0.001 |
| Blood urea nitrogen (mg/dL) |
392 |
15.30 ± 3.92 |
16.35 ± 4.84 |
<0.001 |
| AST (IU/L) |
479 |
30.8 ± 19.7 |
28.8 ± 15.1 |
0.007 |
| ALT (IU/L) |
479 |
31.9 ± 28.2 |
26.8 ± 21.3 |
<0.001 |
| GGT (IU/L) |
451 |
66.1 ± 96.1 |
48.4 ± 69.6 |
<0.001 |
| ALP (IU/L) |
309 |
224.1 ± 87.9 |
184.7 ± 67.5 |
<0.001 |
| CPK (mg/dL) |
301 |
127.8 ± 82.9 |
132.0 ± 95.6 |
0.416 |
| SBP (mmHg) |
489 |
130.4 ± 13.5 |
128.6 ± 12.4 |
0.002 |
| DBP (mmHg) |
486 |
76.0 ± 9.5 |
74.8 ± 8.8 |
0.004 |
| HbA1c (%) | 308 | 6.46 ± 1.41 | 6.39 ± 1.29 | 0.187 |
Data are expressed as mean ± standard deviation safety parameters from baseline to LOCF. The paired t test was used to examine the significance of within-group changes. LOCF: last observation carried forward; AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGT: gamma-glutamyl transpeptidase; ALP: alkaline phosphatase; CPK: creatine phosphokinase; SBP: systolic blood pressure; DBP: diastolic blood pressure; HbA1c: glycated hemoglobin.