Table 2.
Parameter | Placebo, (n = 35) | Pemafibrate (K-877) mg/day | Fenofibrate mg/day 100 (n = 36) |
|||
---|---|---|---|---|---|---|
0.05 (n = 34) | 0.1 (n = 37) | 0.2 (n = 36) | 0.4 (n = 36) | |||
Total C | 0.1 ± 9.8 | −2.7 ± 11.4 | −6.5 ± 11.9**† | −7.0 ± 11.3***† | −5.3 ± 12.9* | −6.0 ± 11.8**† |
Non-HDL-C | 0.7 ± 12.8 | −5.8 ± 12.4* | −11.8 ± 14.0***††† | −12.2 ± 13.8***††† | −10.5 ± 14.2***††† | −10.1 ± 14.2***†† |
VLDL-Ca | 13.3 ± 38.9 | −24.3 ± 24.0***††† | −37.3 ± 26.7***††† | −43.8 ± 24.0***††† | −48.4 ± 27.5***††† | −25.8 ± 29.7***††† |
LDL-Ca | −6.3 ± 16.2* | 8.9 ± 21.3*† | 8.3 ± 29.4† | 5.0 ± 28.0 | 7.4 ± 26.5† | 5.3 ± 23.4† |
Remnant C | 38.7 ± 75.7** | −32.3 ± 33.8***††† | −42.8 ± 29.4***††† | −48.3 ± 28.1***††† | −50.1 ± 31.8***††† | −31.8 ± 35.0***††† |
ApoB | −2.0 ± 9.9 | −1.4 ± 13.6 | −8.9 ± 13.6***† | −7.8 ± 15.0** | −8.1 ± 11.6*** | −5.7 ± 14.4* |
ApoB48 | 54.6 ± 171.1 | −28.4 ± 43.1***††† | −43.1 ± 47.1***††† | −55.9 ± 25.6***††† | −51.2 ± 29.3***††† | −37.9 ± 42.9***††† |
ApoCIII | 7.9 ± 27.4 | −22.2 ± 14.4***††† | −29.0 ± 18.9***††† | −34.6 ± 17.7***††† | −33.4 ± 19.2***††† | −27.2 ± 18.9***††† |
Data are given as mean ± standard deviation (SD) for the percent change from baseline to week 12
Apo apolipoprotein, C cholesterol, HDL high-density lipoprotein, LDL low-density lipoprotein, VLDL very low-density lipoprotein
Significantly different from baseline (week 0) * p < 0.05, ** p < 0.01, *** p < 0.001
Significantly different from placebo † p < 0.05, †† p < 0.01, ††† p < 0.001
Figures in italics: significantly different from fenofibrate p < 0.01
aMeasured by ultracentrifugation