Table 2.
Change in lipids over time by treatment group
| OCA (n=99) | Placebo (n=97) | Treatment Effect‡ | ||||||
|---|---|---|---|---|---|---|---|---|
| Serum-lipids | Visit | Mean (SD) | Change† from BL | Mean (SD) | Change† from BL | Mean | 95% CI | P-value* |
| Total cholesterol – mg/dL | BL | 191 (44) | 190 (48) | 0 | −13, 13 | 0.99 | ||
| F12 | 206 | 8% | 183 | −4% | 23 | 13, 33 | <0.0001 | |
| F72 | 197 | 3% | 185 | −3% | 12 | 2, 22 | 0.02 | |
| F96 | 176 | −8% | 179 | −6% | −3 | −12, 7 | 0.57 | |
| Triglycerides – mg/dL | BL | 219 (312) | 182 (178) | 37 | −35, 108 | 0.31 | ||
| F12 | 160 | −27% | 177 | −3% | −17 | −40, 5 | 0.13 | |
| F72 | 176 | −20% | 176 | 3% | 0 | −34, 34 | 1.00 | |
| F96 | 193 | −12% | 181 | 0% | 12 | −18, 41 | 0.43 | |
| HDL – mg/dL | BL | 42.6 (11.1) | 44.8 (13.9) | −2.2 | −5.7, 1.4 | 0.23 | ||
| F12 | 39.6 | −7% | 43.7 | −2% | −4.1 | −5.9, −2.3 | <0.0001 | |
| F72 | 42.6 | 0% | 45.1 | 1% | −2.6 | −4.6, −0.6 | 0.01 | |
| F96 | 43.9 | 3% | 44.2 | −1% | −0.2 | −2.3, 1.8 | 0.82 | |
| LDL – mg/dL | BL | 111 (39) | 114 (41) | −3 | −15, 8 | 0.59 | ||
| F12 | 137 | 23% | 108 | −5% | 30 | 22, 38 | <0.0001 | |
| F72 | 122 | 10% | 107 | −6% | 15 | 6, 24 | 0.001 | |
| F96 | 100 | −10% | 101 | −11% | −1 | −9, 8 | 0.89 | |
| NMR-VLDL | ||||||||
| Total – nmol/L | BL | 68.6 (38.4) | 59.6 (34.1) | 9.1 | −1.3, 19.2 | 0.09 | ||
| F12 | 61.5 | −10% | 63.3 | 6% | −1.8 | −8.3, 4.7 | 0.59 | |
| F72 | 59.3 | −14% | 58.3 | −2% | 1.1 | −5.6, 7.7 | 0.75 | |
| F96 | 60.0 | −13% | 60.6 | 2% | −0.6 | −7.6, 6.4 | 0.87 | |
| Large – nmol/L | BL | 9.8 (8.2) | 8.9 (8.6) | 0.9 | −1.5, 3.3 | 0.47 | ||
| F12 | 6.7 | −32% | 8.9 | 0% | −2.2 | −3.5, −0.9 | 0.001 | |
| F72 | 8.3 | −15% | 8.2 | −8% | 0.1 | −1.3, 1.6 | 0.85 | |
| F96 | 9.4 | −4% | 9.3 | 4% | 0.1 | −1.8, 1.9 | 0.93 | |
| Medium – nmol/L | BL | 27.3 (25.2) | 22.8 (23.5) | 4.5 | −2.4, 11.4 | 0.20 | ||
| F12 | 21.3 | −22% | 25.7 | 13% | −1.9 | −8.9, 0.2 | 0.06 | |
| F72 | 20.5 | −25% | 23.0 | 1% | −2.5 | −7.3, 2.2 | 0.29 | |
| F96 | 22.4 | −18% | 23.9 | 5% | −1.5 | −5.9, 3.0 | 0.52 | |
| Small – nmol/L | BL | 31.6 (20.3) | 28.0 (15.5) | 3.6 | −1.5, 8.7 | 0.16 | ||
| F12 | 34.2 | 8% | 28.1 | 0% | 6.0 | 1.1, 11.0 | 0.02 | |
| F72 | 30.7 | −3% | 26.8 | −4% | 3.9 | −0.6, 8.4 | 0.09 | |
| F96 | 28.5 | −10% | 26.8 | −4% | 1.9 | −3.0, 6.7 | 0.45 | |
| NMR-LDL | ||||||||
| Total – nmol/L | BL | 1390 (463) | 1424 (476) | −34 | −166, 98 | 0.61 | ||
| F12 | 1668 | 20% | 1335 | −6% | 333 | 230, 437 | <0.0001 | |
| F72 | 1522 | 9% | 1336 | −6% | 187 | 79, 294 | 0.0007 | |
| F96 | 1281 | −8% | 1278 | −10% | 3 | −89, 95 | 0.95 | |
| Large – nmol/L | BL | 288 (237) | 342 (273) | −54 | −126, 18 | 0.14 | ||
| F12 | 477 | 66% | 313 | −8% | 164 | 104, 225 | <0.0001 | |
| F72 | 399 | 39% | 336 | −2% | 63 | 6, 120 | 0.03 | |
| F96 | 272 | −6% | 287 | −16% | −15 | −66, 36 | 0.57 | |
| IDL – nmol/L | BL | 157 (125) | 165 (135) | −8 | −45, 29 | 0.66 | ||
| F12 | 176 | 12% | 151 | −8% | 25 | −11, 60 | 0.17 | |
| F72 | 168 | 7% | 162 | −2% | 6 | −31, 43 | 0.77 | |
| F96 | 129 | −18% | 155 | −6% | −26 | −56, 4 | 0.08 | |
| Small – nmol/L | BL | 946 (418) | 917 (390) | 28 | −85, 142 | 0.62 | ||
| F12 | 1013 | 6% | 872 | −5% | 141 | 51, 232 | 0.002 | |
| F72 | 955 | 1% | 838 | −9% | 117 | 22, 212 | 0.02 | |
| F96 | 878 | −7% | 839 | −9% | 39 | −45, 123 | 0.36 | |
| NMR-HDL | ||||||||
| Total – μmol/L | BL | 34.8 (6.2) | 34.4 (6.8) | 0.4 | −1.4, 2.2 | 0.68 | ||
| F12 | 30.0 | −14% | 34.9 | 1% | −4.8 | −6.0, −3.6 | <0.0001 | |
| F72 | 32.0 | −8% | 34.6 | 1% | −2.6 | −4.0, −1.2 | 0.0003 | |
| F96 | 33.4 | −4% | 35.2 | 2% | −1.8 | −3.2, −0.3 | 0.02 | |
| Large - μmol/L | BL | 6.1 (2.8) | 6.3 (3.4) | −0.2 | −1.1, 0.7 | 0.67 | ||
| F12 | 4.4 | −28% | 6.3 | 0% | −1.8 | −2.3, −1.3 | <0.0001 | |
| F72 | 4.9 | −20% | 6.1 | −3% | −1.2 | −1.8, −0.7 | <0.0001 | |
| F96 | 5.8 | −5% | 5.8 | −8% | −0.1 | −0.6, 0.5 | 0.82 | |
| Medium - μmol/L | BL | 6.5 (4.7) | 7.3 (5.4) | −0.7 | −2.1, 0.7 | 0.33 | ||
| F12 | 5.5 | −15% | 8.0 | 10% | −2.5 | −3.7, −1.2 | 0.0001 | |
| F72 | 5.6 | −15% | 7.2 | −1% | −1.6 | −2.9, −0.3 | 0.02 | |
| F96 | 7.1 | 9% | 8.0 | 10% | −0.8 | −2.1, 0.4 | 0.18 | |
| Small - μmol/L | BL | 22.1 (6.2) | 20.8 (5.7) | 1.3 | −0.4, 3.0 | 0.13 | ||
| F12 | 20.0 | −10% | 20.7 | 0% | −0.7 | −2.2, 0.8 | 0.35 | |
| F72 | 21.6 | −2% | 21.4 | 3% | 0.2 | −1.3, 1.8 | 0.78 | |
| F96 | 20.5 | −7% | 21.4 | 3% | −0.9 | −2.2, 0.5 | 0.20 | |
*
Based on ANOVA for differences at baseline and ANCOVA for differences during follow-up adjusting for baseline value
†
100*[(Mean at FU – Mean at BL) / Mean at BL]
‡
Treatment effect is treatment group difference in change from baseline adjusted for value at baseline