Table 3.
Biochemical Measurements at Baseline and during Follow-Up.
| Baseline | 12 months | 24 months | LS mean change from baseline to 12 months | LS mean change from baseline to 24 months | #Interaction P values | |
|---|---|---|---|---|---|---|
| LDL-C (mg/dl) | ||||||
| Tongxinluo (N) | 113.63 ± 32.96 (595) | 115.05 ± 32.29 (487) | 113.75 ± 31.23 (470) | 0.659 (−1.921, 3.240) | −1.007 (−3.621, 1.607) | 0.283 |
| Placebo (N) | 113.23 ± 32.23 (597) | 116.16 ± 34.77 (492) | 116.62 ± 33.86 (484) | 1.911 (−0.669,4.492) | 3.0781 (0.506, 5.651) | |
| Difference | −1.252 (−4.902, 2.398) | −4.085 (−7.754, −0.417) | ||||
| P values | 0.501 | 0.029 | ||||
| TC (mg/dl) | ||||||
| Tongxinluo (N) | 189.05 ± 43.11 (596) | 190.82 ± 43.05 (488) | 188.15 ± 38.52 (472) | 1.475 (−1.743, 4.694) | −1.634 (−4.891, 1.622) | 0.264 |
| Placebo (N) | 186.22 ± 39.75 (597) | 193.25 ± 43.06 (496) | 193.27 ± 41.01 (486) | 5.701 (2.487, 8.912) | 6.258 (3.053, 9.463) | |
| Difference | −4.225 (−8.775, 0.325) | −7.892 (−12.465, −3.319) | ||||
| P values | 0.069 | <0.001 | ||||
| TG (mg/dl) | ||||||
| Tongxinluo (N) | 140.82 ± 78.72 (596) | 143.56 ± 75.56 (489) | 142.85 ± 78.09 (473) | 1.899 (−2.787, 6.584) | −0.148 (−4.889, 4.593) | 0.943 |
| Placebo (N) | 137.41 ± 81.69 (597) | 146.27 ± 83.83 (496) | 144.70 ± 85.74 (485) | 9.014 (4.332, 13.696) | 7.310 (2.634, 11.985) | |
| Difference | −7.116 (−13.741, −0.490) | −7.458 (−14.118, −0.798) | ||||
| P values | 0.035 | 0.028 | ||||
| HDL-C (mg/dl) | ||||||
| Tongxinluo (N) | 50.43 ± 13.75 (596) | 51.17 ± 12.35 (486) | 51.56 ± 12.40 (470) | 0.644 (−0.295, 1.583) | 1.273 (0.323, 2.223) | 0.346 |
| Placebo (N) | 51.16 ± 12.89 (597) | 50.58 ± 12.79 (492) | 49.92 ± 13.45 (484) | −0.459 (−1.397, 0.480) | −0.734 (−1.669, 0.202) | |
| Difference | 1.102 (−0.226, 2.430) | 2.007 (0.673, 3.340) | ||||
| P values | 0.104 | 0.003 | ||||
| hs-CRP (mg/l) | ||||||
| Tongxinluo (N) | 2.03 ± 2.06 (458) | 1.92 ± 2.35 (350) | 2.04 ± 1.97 (337) | −0.095 (−0.317, 0.128) | −0.011 (−0.237, 0.215) | 0.636 |
| Placebo (N) | 1.87 ± 2.03 (473) | 1.97 ± 2.42 (371) | 2.18 ± 2.42 (344) | 0.045 (−0.172, 0.263) | 0.236 (0.013, 0.459) | |
| Difference | −0.140 (−0.452, 0.171) | −0.247 (−0.565, 0.070) | ||||
| P values | 0.378 | 0.127 | ||||
All continuous values were mean ± SD except fort changed outcome values from baseline to 12 or 24 months which were analyzed by linear mixed-effects model and expressed as least squares (LS) mean and 95% CI. #Interaction p value: the difference between the two groups induced by the interaction between treatment groups and time. LDL-C: low-density lipoprotein cholesterol; TC: total cholesterol; TG: triglycerides; HDL-C: high-density lipoprotein cholesterol; hs-CRP: high-sensitivity C-reactive protein. To convert values of LDL-C, TC and HDL-C to millimoles per liter, multiply by 0.0259. To convert values of TG to millimoles per liter, multiply by 0.0113.