Table 5.
Effects on blood glucose, body weight, and lipids in subgroups classified by baseline LDL-C
| Dose | 100 mg | 200 mg | ||||
|---|---|---|---|---|---|---|
| Total | LDL-C | Total | LDL-C | |||
| <120 mg/dL | ≥120 mg/dL | <120 mg/dL | ≥120 mg/dL | |||
| HbA1c (%) | ||||||
| Number of patients | 584 | 296 | 288 | 713 | 345 | 368 |
| Baseline | 8.05 [0.88] | 8.04 [0.89] | 8.06 [0.87] | 8.09 [0.86] | 8.06 [0.85] | 8.12 [0.88] |
| Week 52 | 7.11 [0.76] | 7.07 [0.71] | 7.16 [0.80] | 7.04 [0.69] | 7.03 [0.71] | 7.06 [0.69] |
| Change from baseline at week 52 | −0.94 [0.77] | −0.97 [0.76] | −0.90 [0.78] | −1.05 [0.76] | −1.03 [0.78] | −1.07 [0.75] |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| FPG (mg/dL) | ||||||
| Number of patients | 583 | 295 | 288 | 711 | 343 | 368 |
| Baseline | 158.9 [35.3] | 156.4 [34.0] | 161.5 [36.6] | 158.9 [34.4] | 157.2 [32.7] | 160.5 [35.9] |
| Week 52 | 129.3 [27.9] | 127.6 [21.7] | 131.0 [33.1] | 124.9 [22.6] | 124.6 [23.9] | 125.3 [21.3] |
| Change from baseline at week 52 | −29.7 [34.2] | −28.8 [29.1] | −30.6 [38.9] | −34.0 [30.7] | −32.6 [31.3] | −35.3 [30.1] |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Body weight (kg) | ||||||
| Number of patients | 584 | 296 | 288 | 713 | 345 | 368 |
| Baseline | 70.44 [15.56] | 69.75 [15.74] | 71.16 [15.37] | 69.73 [14.66] | 69.44 [14.94] | 70.00 [14.40] |
| Week 52 | 67.76 [15.35] | 67.17 [15.56] | 68.37 [15.13] | 66.66 [14.34] | 66.19 [14.59] | 67.11 [14.10] |
| Change from baseline at week 52 | −2.68 [2.51] | −2.58 [2.57] | −2.79 [2.45] | −3.07 [2.79] | −3.26 [2.66] | −2.89 [2.89] |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| LDL-C (mg/dL) | ||||||
| Number of patients | 584 | 296 | 288 | 713 | 345 | 368 |
| Baseline | 120.0 [28.8] | 97.5 [15.0] | 143.2 [19.6] | 122.1 [28.7] | 99.1 [15.1] | 143.6 [20.6] |
| Week 52 | 118.9 [27.9] | 103.2 [21.4] | 134.9 [24.5] | 124.1 [30.0] | 107.8 [23.8] | 139.4 [27.1] |
| Change from baseline at week 52 | −1.2 [22.9] | 5.8 [19.7] | −8.3 [23.8] | 2.1 [24.0] | 8.7 [21.0] | −4.2 [25.0] |
| Paired t test | 0.220 | <0.001 | <0.001 | 0.022 | <0.001 | 0.002 |
| HDL-C (mg/dL) | ||||||
| Number of patients | 584 | 296 | 288 | 713 | 345 | 368 |
| Baseline | 53.7 [12.7] | 53.8 [13.7] | 53.7 [11.8] | 53.8 [13.1] | 53.9 [14.3] | 53.6 [11.9] |
| Week 52 | 58.0 [14.4] | 58.0 [15.3] | 58.0 [13.3] | 58.4 [14.6] | 59.4 [15.8] | 57.5 [13.3] |
| Change from baseline at week 52 | 4.3 [7.8] | 4.2 [8.6] | 4.3 [6.9] | 4.7 [7.7] | 5.4 [7.8] | 3.9 [7.5] |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| LDL-C/HDL-C | ||||||
| Number of patients | 584 | 296 | 288 | 713 | 345 | 368 |
| Baseline | 2.356 [0.784] | 1.926 [0.558] | 2.797 [0.736] | 2.400 [0.789] | 1.965 [0.592] | 2.808 [0.732] |
| Week 52 | 2.173 [0.779] | 1.909 [0.747] | 2.445 [0.716] | 2.262 [0.794] | 1.948 [0.685] | 2.556 [0.777] |
| Change from baseline at week 52 | −0.182 [0.567] | −0.017 [0.578] | −0.352 [0.502] | −0.138 [0.500] | −0.017 [0.408] | −0.252 [0.550] |
| Paired t test | <0.001 | 0.613 | <0.001 | <0.001 | 0.441 | <0.001 |
| Triglyceride (mg/dL) | ||||||
| Number of patients | 583 | 295 | 288 | 711 | 343 | 368 |
| Baseline | 143.6 [94.4] | 144.2 [107.7] | 142.9 [78.8] | 152.4 [105.8] | 153.0 [125.1] | 151.9 [84.0] |
| Week 52 | 131.9 [106.3] | 137.4 [126.0] | 126.2 [81.1] | 130.7 [95.0] | 128.6 [96.2] | 132.6 [93.9] |
| Change from baseline at week 52 | −11.7 [103.7] | −6.9 [121.8] | −16.7 [81.0] | −21.7 [96.8] | −24.4 [105.8] | −19.3 [87.7] |
| Paired t test | 0.007 | 0.335 | <0.001 | <0.001 | <0.001 | <0.001 |
Missing data at week 52 were imputed using last observation carried forward method. Data were shown as mean [standard deviation]
FPG fasting plasma glucose, HbA1c hemoglobin A1c, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol