Table 4.
HDL inflammatory index pharmacodynamics: postdose time course over 8 h on day 13
| Parameter | Sucrose Placebo | 100 mg D‐4F + Sucrose | 300 mg D‐4F + Sucrose | 500 mg D‐4F + Sucrose |
|---|---|---|---|---|
| 0 h postdose | ||||
| HII | 1.25 UR (1.09–1.41) | 1.21 UR (1.05–1.37) | 1.35 UR (1.19–1.51) | 1.22 UR (1.05–1.39) |
| 2 h postdose | ||||
| HII | 0.82 UR (0.66–0.98) | 0.99 UR (0.83–1.15) | 0.79 UR (0.63–0.95) | 0.73 UR (0.56–0.90) |
| Delta‐HII | ‒0.43 UR (‒0.25,‒0.61) | ‒0.22 UR (‒0.04,‒0.39) | ‒0.56 UR (‒0.39,‒0.74) | ‒0.50 UR (‒0.31,‒0.68) |
| Percent change | ‒31.1% (‒43.7,‒18.6%) | ‒15.8% (‒28.4,‒3.2%) | ‒37.8% (‒50.3,‒25.2%) | ‒40.5% (‒53.5,‒27.5%) |
| P = 0.0001 | P = 0.0153 | P = 0.0001 | P = 0.0001 | |
| Placebo‐adjusted percent change | +15.3% (‒2.6,+33.3%) | ‒6.7% (‒24.6,+11.3%) | ‒9.4% (‒27.6,+8.9%) | |
| P = 0.0936 | P = 0.4648 | P = 0.3118 | ||
| Fast ended and subjects took daily medications, including morning ASCVD‐prevention regimen | ||||
| 4 h postdose / 2 h post‐ASCVD regimen and breakfast | ||||
| HII | 0.91 UR (0.75–1.07) | 1.10 UR (0.94–1.26) | 0.71 UR (0.55–0.87) | 0.74 UR (0.57–0.91) |
| Delta‐HII | ‒0.34 UR (‒0.17,‒0.52) | ‒0.12 UR (+0.06,‒0.29) | ‒0.64 UR (‒0.47,‒0.82) | ‒0.48 UR (‒0.30,‒0.66) |
| Percent change | ‒26.1% (‒38.6,‒13.5%) | ‒7.1% (‒19.6,+5.5%) | ‒44.5% (‒57.1,‒32.0%) | ‒38.3% (‒51.3,‒25.3%) |
| P = 0.0001 | P = 0.2714 | P = 0.0001 | P = 0.0001 | |
| Placebo‐adjusted percent change | +19.0% (+1.0,+36.9%) | ‒18.5% (‒36.4,‒0.5%) | ‒12.2% (‒30.5,+6.0%) | |
| P = 0.0386 | P = 0.0441 | P = 0.1875 | ||
| 8 h postdose / 4 h post‐ASCVD regimen and breakfast | ||||
| HII | 0.86 UR (0.70–1.02) | 1.00 UR (0.84–1.16) | 0.57 UR (0.41–0.73) | 0.63 UR (0.46–0.80) |
| Delta‐HII | ‒0.39 UR (‒0.21,‒0.56) | ‒0.22 UR (‒0.04,‒0.39) | ‒0.79 UR (‒0.61,‒0.96) | ‒0.59 UR (‒0.41,‒0.77) |
| Percent change | ‒27.9% (‒40.5,‒15.4%) | ‒16.6% (‒29.2,‒4.0%) | ‒54.7% (‒67.2,‒42.1%) | ‒48.5% (‒61.5,‒35.5%) |
| P = 0.0001 | P = 0.0109 | P = 0.0001 | P = 0.0001 | |
| Placebo‐adjusted percent change | +11.3% (‒6.6,+29.3%) | ‒26.8% (‒44.7,‒8.8%) | ‒20.6% (‒38.9,‒2.3%) | |
| P = 0.2140 | P = 0.0039 | P = 0.0276 | ||
ASCVD, atherosclerotic cardiovascular disease; HDL, high‐density lipoprotein; HII, high‐density lipoprotein inflammatory index; UR, unit ratio, the native units for HII.
ASCVD Delta‐HII is simply the postdose HII minus predose HII on the UR scale. Percent change is Delta‐HII/predose HII × 100% on the percent scale. The placebo‐adjusted percent change subtracts the percent change from the placebo group for each group on active D‐4F, on the percent scale. Data are presented as mean (95% confidence interval).