TABLE 4.
Changes in lipoprotein, lipid and glucose levels from baseline to after 8 weeks of treatment (FAS and PPS population).
| RSV10 mg/AML5 mg test group 1, N = 85 | RSV20 mg/AML5 mg test group 2, N = 85 | ATV20 mg/AML5 mg control group, N = 86 | P‐value | P‐value | ||||
|---|---|---|---|---|---|---|---|---|
| Lipids/lipoprotein/glucose (FAS) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | ANCOVA test group 1 – Control group | ANCOVA test group 2– Control group |
| TC | 212.8 ± 32.3 | −32.7 ± 9.2 | 221.1 ± 30.2 | −34.9 ± 12.7 | 220.8 ± 34.3 | −30.5 ± 13.1 | .1115 | .0246 |
| HDL‐C | 46.1 ± 11.7 | 11.3 ± 15.2 | 48.0 ± 11.1 | 10.1 ± 14.9 | 47.2 ± 11.9 | 7.6 ± 16.0 | .2056 | .2272 |
| TG | 183.1 ± 93.7 | −15.3 ± 40.3 | 166.2 ± 70.9 | −16.4 ± 30.7 | 193.7 ± 225.3 | −16.6 ± 35.6 | .9521 | .7266 |
| Apo B | 129.8 ± 23.2 | −39.7 ± 9.6 | 135.9 ± 21.9 | −42.9 ± 14.6 | 134.6 ± 23.1 | −36.1 ± 15.1 | .0548 | .0038 |
| Apo A‐1 | 143.0 ± 25.6 | 7.8 ± 13.5 | 144.1 ± 22.2 | 7.3 ± 12.5 | 143.5 ± 22.6 | 3.3 ± 9.4 | .0175 | .0174 |
| Apo B/Apo A‐1 | 0.94 ± 0.25 | −44.1 ± 11.0 | 0.97 ± 0.23 | −46.8 ± 15.3 | 0.96 ± 0.24 | −36.9 ± 15.5 | .0006 | <.0001 |
| Lp (a) | 40.8 ± 50.7 | 15.9 ± 32.4 | 48.0 ± 68.1 | 8.7 ± 40.3 | 34.0 ± 44.3 | 0.78 ± 33.9 | .0048 | .2094 |
| hs‐CRP | 1.3 ± 2.0 | 13.2 ± 127.9 | 1.4 ± 1.6 | −4.2 ± 175.4 | 1.2 ± 1.4 | 90.9 ± 522.4 | .2128 | .1353 |
| FBG | 118.0 ± 23.4 | 1.1 ± 11.8 | 114.2 ± 26.8 | 1.8 ± 13.8 | 117.6 ± 23.1 | 1.7 ± 12.3 | .7548 | .8854 |
| HbA1c | 6.1 ± 0.74 | 0.59 ± 6.2 | 6.1 ± 0.79 | 0.99 ± 5.5 | 6.3 ± 0.91 | 0.25 ± 4.7 | .7144 | .2370 |
| HOMA‐IR | 3.2 ± 2.2 | 12.7 ± 76.3 | 6.9 ± 36.2 | 33.1 ± 82.5 | 2.9 ± 2.2 | 42.4 ± 105.2 | .0539 | .5861 |
| RSV10 mg/AML5 mg test group 1, N = 77 | RSV20 mg/AML5 mg test group 2, N = 81 | ATV20 mg/AML5 mg control group, N = 79 | P‐value | P‐value | ||||
|---|---|---|---|---|---|---|---|---|
| Lipids/lipoprotein/glucose (PPS) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | Baseline level mean ± SD, mg/dL | % change, mean ± SD (w8‐baseline) | ANCOVA test group 1 – Control group | ANCOVA test group 2– Control group |
| TC | 213.7 ± 32.1 | −33.1 ± 9.0 | 220.8 ± 30.8 | −35.7 ± 11.3 | 223.8 ± 32.6 | −30.8 ± 12.8 | .1305 | .0074 |
| HDL‐C | 45.7 ± 11.6 | 11.7 ± 15.4 | 47.8 ± 11.3 | 10.3 ± 15.1 | 47.6 ± 12.0 | 8.5 ± 15.8 | .3246 | .4221 |
| TG | 183.4 ± 96.8 | −15.6 ± 40.7 | 167.0 ± 72.0 | −17.8 ± 30.2 | 196.2 ± 234.1 | −17.4 ± 35.7 | .9072 | .6214 |
| Apo B | 130.9 ± 23.3 | −40.1 ± 9.3 | 135.9 ± 22.3 | −43.9 ± 12.8 | 136.1 ± 22.3 | −36.5 ± 14.6 | .0695 | .0008 |
| Apo A‐1 | 141.8 ± 25.2 | 8.2 ± 13.7 | 143.7 ± 22.5 | 7.2 ± 12.6 | 144.8 ± 21.9 | 3.5 ± 9.3 | .0171 | .0340 |
| Apo B/Apo A‐1 | 0.96 ± 0.26 | −44.8 ± 10.6 | 0.98 ± 0.23 | −47.8 ± 13.6 | 0.96 ± 0.23 | −37.5 ± 14.7 | .0004 | <.0001 |
| Lp (a) | 40.6 ± 48.1 | 16.0 ± 32.0 | 48.2 ± 68.9 | 8.9 ± 40.5 | 35.5 ± 45.8 | −0.34 ± 33.3 | .0026 | .1410 |
| hs‐CRP | 1.40 ± 2.1 | 13.4 ± 130.3 | 1.40 ± 1.6 | −5.6 ± 178.3 | 1.2 ± 1.4 | 94.7 ± 538.1 | .2221 | .1351 |
| FBG | 117.7 ± 23.1 | 1.7 ± 11.5 | 113.9 ± 27.2 | 2.1 ± 14.0 | 117.0 ± 20.2 | 1.7 ± 12.1 | .9900 | .9488 |
| HbA1c | 6.2 ± 0.7 | 0.75 ± 6.2 | 6.0 ± 0.8 | 1.1 ± 5.5 | 6.2 ± 0.6 | 0.6 ± 4.5 | .8572 | .3196 |
| HOMA‐IR | 3.2 ± 2.2 | 13.7 ± 77.5 | 7.1 ± 37.1 | 34.1 ± 83.6 | 2.9 ± 2.2 | 44.0 ± 106.0 | .0572 | .5766 |
Note: Values are given as mean ± standard deviation.
Abbreviations: AML, amlodipine; ANCOVA, analysis of covariance; Apo A‐1, apolipoprotein A1; Apo B, apolipoprotein B; ATV, atorvastatin; CI, confidence interval; Hba1c, hemoglobin a1c; FAS, full analysis set; FBG, fasting blood glucose; HDL‐C, high‐density lipoprotein cholesterol; HOMAR‐IR, homeostatic model assessment for insulin resistance; LDL‐C, low‐density lipoprotein cholesterol; Lp (a), lipoprotein (a); TC, total cholesterol; TG, triglyceride; PPS, per protocol set; RSV, rosuvastatin; SD, standard deviation.