Table 3.
Effect of CHF 4227 on total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride concentrations after 4 weeks of treatment. Baseline, day 29 values, absolute and % changes from baseline (mean ± SEM), least square means (LSM) of the difference from placebo ant its 95% confidence intervals (95% C.I) are reported
| CHF 4227 dose | |||||||
|---|---|---|---|---|---|---|---|
| 5 mg | 10 mg | 25 mg | 50 mg | 100 mg | Placebo | ||
| Total cholesterol (mmol l−1) | Baseline | 6.93 ± 0.34 | 6.79 ± 0.34 | 6.51 ± 0.39 | 6.00 ± 0.20 | 5.62 ± 0.50 | 6.26 ± 0.25 |
| Day 29 | 5.64 ± 0.20* | 5.70 ± 0.37 | 5.51 ± 0.39 | 5.21 ± 0.26 | 4.70 ± 0.20* | 5.92 ± 0.18 | |
| Absolute change | −1.29 ± 0.32 | −1.09 ± 0.13 | −1.00 ± 0.09 | −0.79 ± 0.20 | −0.88 ± 0.39 | −0.35 ± 0.14 | |
| % change | −17.4 ± 4.11 | −15.7 ± 2.12 | −15.7 ± 1.61 | −13.1 ± 2.99 | −14.1 ± 4.93 | −4.79 ± 2.18 | |
| LSM difference | −0.72* | −0.56 | −0.57 | −0.53 | −0.75* | ||
| 95% CI | −1.34; −0.09 | −1.20; 0.07 | −1.15; 0.01 | −1.13; 0.07 | −1.47; −0.02 | ||
| HDL cholesterol (mmol l−1) | Baseline | 2.15 ± 0.17 | 1.86 ± 0.20 | 1.83 ± 0.20 | 1.58 ± 0.11 | 1.62 ± 0.13 | 1.91 ± 0.14 |
| Day 29 | 1.71 ± 0.14 | 1.70 ± 0.17 | 1.58 ± 0.16 | 1.66 ± 0.18 | 1.68 ± 0.22 | 1.65 ± 0.12 | |
| Absolute change | −0.41 ± 0.12 | −0.16 ± 0.11 | −0.26 ± 0.10 | 0.09 ± 0.19 | 0.06 ± 0.12 | −0.25 ± 0.05 | |
| % change | −17.4 ± 6.62 | −6.5 ± 5.48 | −13.% ± 3.97 | 8.7 ± 14.36 | 2.7 ± 8.27 | −12.67 ± 2.81 | |
| LSM difference | −0.09 | 0.08 | −0.02 | 0.25 | 0.24 | ||
| 95% CI | −0.46; 0.28 | −0.30; 0.46 | −0.37; 0.33 | −0.12; 0.62 | −0.20; 0.67 | ||
| LDL cholesterol (mmol l−1) | Baseline | 4.23 ± 0.25 | 4.36 ± 0.30 | 4.14 ± 0.38 | 4.01 ± 0.26 | 3.54 ± 0.57 | 3.91 ± 0.24 |
| Day 29 | 3.20 ± 0.17** | 3.50 ± 0.28* | 3.48 ± 0.36 | 3.08 ± 0.17** | 2.52 ± 0.36** | 3.81 ± 0.21 | |
| Absolute change | −1.03 ± 0.25 | −0.86 ± 0.17 | −0.67 ± 0.07 | −0.94 ± 0.25 | −1.02 ± 0.38 | −0.10 ± 0.12 | |
| % change | −22.7 ± 5.23 | −19.4% ± 3.63 | −17.1 ± 1.66 | −24.0 ± 4.59 | −27.6 ± 6.72 | −1.08 ± 3.69 | |
| LSM difference | −0.82** | −0.60* | −0.48 | −0.80** | −1.05** | ||
| 95% CI | −1.37; −0.25 | −1.19; −0.01 | −1.02; 0.05 | −1.35; −0.24 | −1.70; −0.38 | ||
| Triglycerides (mmol l−1) | Baseline | 1.22 ± 0.11 | 1.34 ± 0.27 | 1.14 ± 0.13 | 0.92 ± 0.08 | 1.11 ± 0.12 | 0.99 ± 0.08 |
| Day 29 | 1.25 ± 0.03 | 1.11 ± 0.08 | 0.99 ± 0.11 | 1.05 ± 0.14 | 0.92 ± 0.10 | 1.01 ± 0.07 | |
| Absolute change | 0.04 ± 0.11 | −0.23 ± 0.20 | −0.14 ± 0.11 | 0.13 ± 0.08 | −0.08 ± 0.07 | −0.09 ± 0.15 | |
| % change | 13.1 ± 11.0 | −6.00 ± 11.43 | −9.94 ± 8.27 | 12.04 ± 7.30 | −8.19 ± 7.23 | −0.05 ± 11.93 | |
| LSM difference | 0.38 | −0.05 | −0.08 | 0.08 | 0.17 | ||
| 95% CI | −0.10; 0.85 | −0.55; 0.44 | −0.54; 0.37 | −0.38; 0.55 | −0.38; 0.71 | ||
*,**
Statistically significant difference between active and placebo, P < 0.05 and P < 0.01, respectively, Dunnett's test.