Table 3.
Change in lipid particle concentrations
| Parameter | Baseline | Endpoint | Change from baseline | ||
|---|---|---|---|---|---|
| Treatment difference | |||||
| LS mean | LS mean | p-valuea | |||
| Total LDL-P, nmol/L | |||||
| Placebo | 1,563 | 1,591 | 24 | −143 | <0.0001 |
| Colesevelam | 1,611 | 1,487 | −119 | ||
| Large LDL-P, nmol/L | |||||
| Placebo | 325 | 328 | 2 | −60 | 0.002 |
| Colesevelam | 339 | 278 | −59 | ||
| Medium small LDL-P, nmol/L | |||||
| Placebo | 236 | 240 | 3 | −9 | 0.31 |
| Colesevelam | 240 | 234 | −6 | ||
| Small LDL-P, nmol/L | |||||
| Placebo | 1,169 | 1,195 | 22 | −82 | <0.05 |
| Colesevelam | 1,203 | 1,140 | −60 | ||
| Very small LDL-P, nmol/L | |||||
| Placebo | 933 | 955 | 19 | −73 | 0.03 |
| Colesevelam | 963 | 906 | −54 | ||
| Total VLDL-P/chylomicron, nmol/L | |||||
| Placebo | 86 | 92 | 6 | −0.8 | 0.82 |
| Colesevelam | 88 | 94 | 5 | ||
| Large VLDL/chylomicron, nmol/L | |||||
| Placebo | 6 | 7 | 0.7 | 1 | 0.08 |
| Colesevelam | 6 | 8 | 2 | ||
| Medium VLDL, nmol/L | |||||
| Placebo | 38 | 41 | 4 | 4 | 0.17 |
| Colesevelam | 38 | 45 | 7 | ||
| Small VLDL, nmol/L | |||||
| Placebo | 42 | 44 | 2 | −5 | 0.03 |
| Colesevelam | 45 | 41 | −3 | ||
| Total HDL-P, umol/L | |||||
| Placebo | 31 | 32 | 0.4 | 0.6 | 0.20 |
| Colesevelam | 31 | 32 | 1 | ||
| Large HDL-P, umol/L | |||||
| Placebo | 5 | 5 | −0.2 | 0.5 | 0.007 |
| Colesevelam | 5 | 5 | 4 | ||
| Medium HDL-P, umol/L | |||||
| Placebo | 3 | 3 | 0.2 | 0.8 | 0.02 |
| Colesevelam | 3 | 4 | 1 | ||
| Small HDL-P, umol/L | |||||
| Placebo | 24 | 24 | 0.3 | −0.8 | 0.10 |
| Colesevelam | 24 | 23 | −0.5 | ||
Reported changes are measured from baseline to Week 24 with last observation carried forward (intent-to-treat population)
HDL-P high-density lipoprotein particle concentration, LDL-P low-density lipoprotein particle concentration, LS least squares, VLDL-P very low-density lipoprotein particle concentration
a p-values are not adjusted for multiple comparisons