TABLE 5.
Linear mixed model, P value3 | |||||||
---|---|---|---|---|---|---|---|
Group | 0 wk | 4 wk | 8 wk | 12 wk | Interaction | 12 wk | |
Systolic blood pressure, mmHg | Placebo | 120 ± 16 | 122 ± 12 | 121 ± 13 | 120 ± 13 | 0.189 | 0.934 |
OLL2712 | 119 ± 12 | 122 ± 9 | 119 ± 12 | 120 ± 13 | |||
Diastolic blood pressure, mmHg | Placebo | 71.4 ± 10.9 | 71.7 ± 11.6 | 73.6 ± 9.6 | 73.3 ± 8.9 | 0.332 | 0.814 |
OLL2712 | 69.9 ± 8.4 | 70.1 ± 8.6 | 70.6 ± 9.0 | 72.2 ± 9.2 | |||
Heart rate, bpm | Placebo | 71.5 ± 11.1 | 74.2 ± 11.8 | 73.6 ± 9.8 | 75.9 ± 10.5** | 0.713 | 0.241 |
OLL2712 | 74.6 ± 9.6 | 74.8 ± 10.3 | 73.3 ± 10.8 | 75.5 ± 12.2 | |||
Serum total cholesterol, mg/dL | Placebo | 216 ± 34 | 223 ± 34 | 219 ± 35 | 215 ± 37 | 0.745 | 0.547 |
OLL2712 | 204 ± 37 | 208 ± 37 | 206 ± 38 | 202 ± 36 | |||
Serum LDL cholesterol, mg/dL | Placebo | 134 ± 28 | 136 ± 31 | 135 ± 28 | 137 ± 33 | 0.495 | 0.402 |
OLL2712 | 126 ± 32 | 125 ± 32 | 127 ± 34 | 126 ± 32 | |||
Serum HDL cholesterol, mg/dL | Placebo | 48.3 ± 10.4 | 50.0 ± 10.3 | 49.8 ± 9.9 | 49.9 ± 9.4 | 0.924 | 0.448 |
OLL2712 | 49.4 ± 9.1 | 51.3 ± 8.0 | 51.2 ± 8.9 | 51.6 ± 9.0** | |||
Serum triglycerides, mg/dL | Placebo | 142 ± 171 | 158 ± 145 | 157 ± 162 | 143 ± 157 | 0.838 | 0.273 |
OLL2712 | 122 ± 62 | 135 ± 106 | 127 ± 75 | 116 ± 49 |
Values are means ± SD, n = 46 in each group.
Significant differences in measurements compared with baseline (0 wk) were determined using the paired samples t-tests or the Wilcoxon signed-rank tests (**P < 0.01).
The group-by-time interaction and intergroup differences were evaluated using a linear mixed model with the model using the amount of change (not including 0 wk) as the response variable, group, time, and group-by-time interaction as fixed effects, the baseline value as the covariate, and time point as a repeated effect. PPS, per-protocol set.