Characteristic | Weeks after pemafibrate treatment | Pemafibrate treatment | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week −8 | Week −4 | Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | P* | Baselinea | Post-doseb | P** | |
AST, median (IQR), | IU/L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 21 (18–29) | 22 (18–30) | 23 (19–33) | 21 (18–34) | 23 (18–31) | 24 (21–44) | 23 (19–29) | 22 (19–33) | 21 (19–29) | 0.9212 | 23 (18–31) | 23 (19–31) | 0.9139 |
 Increased LDL-C group (group I) | 23 (19–34) | 26 (21–33) | 23 (20–36) | 19 (18–32) | 20 (17–33) | 26 (21–48) | 23 (18–40) | 23 (20–43) | 20 (19–22) | 0.6619 | 23 (19–34) | 21 (18–34) | 0.3833 |
 No LDL-C increase group (group NI) | 20 (17–27) | 20 (17–29) | 20 (18–29) | 21 (19–35) | 24 (19–28) | 23 (21–40) | 24 (20–28) | 21 (17–49) | 23 (16–34) | 0.9440 | 20 (18–28) | 25 (20–29) | 0.6184 |
 P*** | 0.2611 | 0.1970 | 0.1894 | 0.4655 | 0.3690 | 0.6480 | 0.9545 | 0.5388 | 0.8421 |  | 0.2273 | 0.4646 |  |
ALT, median (IQR), | IU/L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 22 (18–36) | 26 (18–37) | 23 (18–40) | 19 (16–29) | 20 (17–27) | 19 (17–58) | 21 (16–31) | 18 (15–23) | 17 (15–24) | 0.1297 | 24 (17–37) | 19 (16–30) | 0.0010 |
 Increased LDL-C group (group I) | 28 (19–40) | 30 (19–39) | 31 (19–41) | 19 (17–28) | 20 (15–38) | 19 (16–62) | 23 (17–38) | 19 (15–33) | 18 (14–25) | 0.1802 | 31 (21–40) | 19 (16–34) | 0.0040 |
 No LDL-C increase group (group NI) | 22 (17–29) | 23 (16–36) | 20 (17–29) | 19 (15–38) | 20 (17–25) | 17 (17–53) | 21 (16–30) | 18 (14–53) | 17 (15–24) | 0.9352 | 22 (17–29) | 21 (17–26) | 0.0909 |
 P*** | 0.1606 | 0.1605 | 0.0582 | 1.0000 | 0.9269 | 0.9091 | 0.5141 | 1.0000 | 0.8427 |  | 0.0520 | 0.9918 |  |
γGTP, median (IQR), | IU/L |  |  |  |  |  |  |  |  |  |  |  |  |
 Total | 34 (26–94) | 46 (28–83) | 39 (24–92) | 34 (21–48) | 30 (18–47) | 43 (31–74) | 28 (15–57) | 34 (20–57) | 33 (20–65) | 0.0656 | 37 (26–86) | 31 (19–54) | <0.0001 |
 Increased LDL-C group (group I) | 43 (31–98) | 67 (31–110) | 53 (28–102) | 39 (29–60) | 32 (22–53) | 53 (32–80) | 37 (14–71) | 40 (29–67) | 38 (25–71) | 0.2944 | 48 (28–101) | 34 (26–75) | < 0.0001 |
 No LDL-C increase group (group NI) | 31 (20–77) | 36 (24–63) | 32 (18–54) | 20 (12–49) | 23 (17–34) | 31 (14–44) | 25 (16–47) | 18 (13–46) | 31 (15–49) | 0.4730 | 30 (19–62) | 26 (17–43) | <0.0001 |
 P*** | 0.0975 | 0.0643 | 0.0382 | 0.1118 | 0.1074 | 0.0471 | 0.2486 | 0.0570 | 0.1392 |  | 0.0600 | 0.0992 |  |
HbA1c, mean (SD), | % | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 7.5 (1.5) | 7.7 (1.5) | 7.4 (1.6) | 7.6 (1.2) | 7.4 (1.6) | 7.2 (1.4) | 7.2 (1.3) | 7.9 (1.4) | 7.1 (1.9) | 0.7897 | 7.4 (1.4) | 7.3 (1.5) | 0.0502 |
 Increased LDL-C group (group I) | 7.6 (1.7) | 7.5 (1.3) | 7.2 (1.1) | 7.4 (1.3) | 7.3 (1.3) | 7.0 (1.6) | 7.3 (1.4) | 7.7 (1.8) | 6.7 (1.4) | 0.8251 | 7.2 (1.3) | 7.1 (1.3) | 0.1510 |
 No LDL-C increase group (group NI) | 7.5 (2.0) | 8.0 (1.6) | 7.5 (2.0) | 7.8 (1.1) | 7.5 (1.9) | 7.4 (1.1) | 7.2 (1.3) | 8.1 (0.8) | 7.4 (2.3) | 0.9534 | 7.5 (1.5) | 7.4 (1.6) | 0.1561 |
 P*** | 0.7866 | 0.3344 | 0.5476 | 0.5551 | 0.6126 | 0.6060 | 0.7508 | 0.6851 | 0.3621 |  | 0.5568 | 0.4819 |  |