Table 3. Distributions of Inflammatory and Immune Biomarkers at Entry and Month 24.
| Measurea | Median (IQR) | ||||
|---|---|---|---|---|---|
| Entry | Month 24 | ||||
| Pitavastatin (n = 402) | Placebo (n = 402) | Pitavastatin (n = 349) | Placebo (n = 350) | P value | |
| Inflammatory markers | |||||
| LpPLA2 | |||||
| Total, No. | 398 | 391 | 335 | 333 | NA |
| LpPLA2 level, ng/mL | 126 (94.8-169) | 131 (89.6-163) | 119 (84.0-160) | 143 (105-186) | <.001 |
| Change from baseline | NA | NA | −9.77 (−33.6 to 16.8) | 19.9 (−5.6 to 43.0) | <.001 |
| Mean fold change (95% CI) | NA | NA | 0.93 (0.89-0.96) | 1.14 (1.10-1.18) | NA |
| oxLDL | |||||
| Total, No. | 398 | 392 | 335 | 333 | NA |
| oxLDL level, U/L | 53.0 (42.2-69.8) | 53.6 (41.7-69.9) | 37.6 (30.0-47.3) | 48.2 (38.9-58.4) | <.001 |
| Change from baseline | NA | NA | −14.9 (−28.9 to −3.93) | −6.45 (−20.2 to 5.26) | <.001 |
| Mean fold change (95% CI) | NA | NA | 0.71 (0.68-0.74) | 0.87 (0.83-0.91) | NA |
| hsCRPb | |||||
| Total, No. | 397 | 391 | 343 | 335 | NA |
| hsCRP level, mg/dL | 0.18 (0.08-0.39) | 0.18 (0.09-0.33) | 0.17 (0.07-0.36) | 0.19 (0.10-0.40) | .02 |
| Change from baseline | NA | NA | −0.01 (−0.10 to 0.08) | 0.01 (−0.09 to 0.11) | .09 |
| Mean fold change (95% CI) | NA | NA | 0.89 (0.79-1.01) | 1.06 (0.94-1.20) | NA |
| Immune markers | |||||
| MCP-1 | |||||
| Total, No. | 398 | 390 | 335 | 330 | NA |
| MCP-1 level, pg/mL | 189 (148-245) | 183 (144-238) | 192 (157-235) | 193 (154-247) | .77 |
| Change from baseline | NA | NA | 2.11 (−37.8 to 47.5) | 3.91 (−33.3 to 53.2) | .46 |
| Mean fold change (95% CI) | NA | NA | 1.02 (0.98-1.06) | 1.05 (1.01-1.09) | NA |
| Soluble CD14 | |||||
| Total, No. | 398 | 392 | 335 | 333 | NA |
| Soluble CD14 level, ng/mL | 1840 (1544-2176) | 1810 (1496-2200) | 1541 (1284-1809) | 1534 (1324-1850) | .52 |
| Change from baseline | NA | NA | −289 (−588 to −5.08) | −237 (−528 to 36.1) | .54 |
| Mean fold change (95% CI) | NA | NA | 0.83 (0.81-0.86) | 0.86 (0.83-0.88) | NA |
| Soluble CD163 | |||||
| Total, No. | 398 | 391 | 335 | 333 | NA |
| Soluble CD163 level, ng/mL | 849 (651-1163) | 845 (613-1074) | 1013 (728-1419) | 1003 (745-1384) | .65 |
| Change from baseline | NA | NA | 149 (−60.8 to 420) | 143 (−46.0 to 453) | .88 |
| Mean fold change (95% CI) | NA | NA | 1.21 (1.16-1.27) | 1.23 (1.18-1.29) | NA |
| IL-6 | |||||
| Total, No. | 398 | 391 | 335 | 333 | NA |
| IL-6 level, pg/mL | 1.64 (0.99-2.76) | 1.46 (0.98-2.59) | 1.64 (0.99-2.73) | 1.53 (0.93-2.62) | .24 |
| Change from baseline | NA | NA | 0 (−0.95 to 0.77) | −0.12 (−0.81 to 0.59) | .46 |
| Mean fold change (95% CI) | NA | NA | 0.98 (0.89-1.08) | 0.94 (0.86-1.03) | NA |
| IL-1β | |||||
| Total, No. | 377 | 375 | 320 | 320 | NA |
| IL-1β level, fg/mL | 75.9 (43.9-151) | 87.0 (44.9-168) | 88.6 (50.2-164) | 96.4 (52.6-191) | .09 |
| Change from baseline | NA | NA | 2.01 (−41.4 to 58.1) | 11.4 (−28.9 to 69.2) | .06 |
| Mean fold change (95% CI) | NA | NA | 1.05 (0.93-1.17) | 1.19 (1.07-1.33) | NA |
| IL-18 | |||||
| Total, No. | 377 | 375 | 320 | 320 | NA |
| IL-18 level, pg/mL | 245 (179-330) | 232 (169-310) | 236 (169-310) | 230 (176-308) | .79 |
| Change from baseline | NA | NA | −8.53 (−48.2 to 35.3) | −3.77 (−43.3 to 44.1) | .26 |
| Mean fold change (95% CI) | NA | NA | 0.96 (0.92-1.00) | 1.01 (0.97-1.04) | NA |
| IL-10 | |||||
| Total, No. | 363 | 353 | 305 | 300 | NA |
| IL-10 level, pg/mL | 0.24 (0.17-0.37) | 0.22 (0.16-0.35) | 0.21 (0.15-0.34) | 0.22 (0.16-0.33) | .53 |
| Change from baseline | NA | NA | −0.02 (−0.12 to 0.06) | 0 (−0.09 to 0.09) | .08 |
| Mean fold change (95% CI) | NA | NA | 0.96 (0.87-1.05) | 0.99 (0.91-1.07) | NA |
| Caspase-1 | |||||
| Total, No. | 377 | 375 | 320 | 320 | NA |
| Caspase-1 level, pg/mL | 66.6 (47.0-93.8) | 69.6 (50.1-107) | 69.6 (48.6-102) | 74.2 (52.6-113) | .08 |
| Change from baseline | NA | NA | −3.41 (−22.2 to 26.2) | 5.61 (−18.6 to 30.5) | .07 |
| Mean fold change (95% CI) | NA | NA | 1.02 (0.94-1.10) | 1.07 (0.98-1.16) | NA |
Abbreviations: hsCRP, high-sensitivity C-reactive protein; IL, interleukin; LpPLA2, lipoprotein-associated phospholipase A2; MCP-1, monocyte chemoattractant protein 1; NA, not applicable; oxLDL, oxidized low-density lipoprotein.
SI conversion factor: To convert hsCRP to mg/L, multiply by 10.
a
Data are reported for all enrolled participants with available biomarker results.
b
For hsCRP, censored values below the assay limit are randomly imputed based on a uniform distribution; otherwise, censored values below the assay limit are imputed as the result −0.01; values above the assay limit are imputed as result 0.1.