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** | |
TG, median (IQR), | mmol/L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 3.01 (2.50–4.08) | 3.49 (2.60–5.43) | 3.60 (2.69–5.44) | 2.19 (1.55–2.47) | 2.11 (1.47–2.42) | 1.99 (1.42–2.87) | 2.27 (1.72–2.81) | 2.70 (2.01–3.59) | 2.08 (1.75–2.69) | < 0.0001 | 3.30 (2.63–4.76) | 2.15 (1.72–2.44) | < 0.0001 |
 Increased LDL-C group (group I) | 3.25 (2.47–6.27) | 4.52 (2.63–6.11) | 4.03 (2.60–7.24) | 2.22 (1.56–2.47) | 2.07 (1.40–2.45) | 2.00 (1.85–3.07) | 2.27 (1.73–3.10) | 2.74 (2.04–4.21) | 1.90 (1.59–2.83) | < 0.0001 | 3.71 (2.62–6.69) | 2.11 (1.61–2.57) | < 0.0001 |
 No LDL-C increase group (group NI) | 2.90 (2.51–3.77) | 3.01 (2.31–4.03) | 3.26 (2.77–4.08) | 2.10 (1.50–2.54) | 2.17 (1.68–2.42) | 1.70 (1.26–2.50) | 2.22 (1.64–2.69) | 2.57 (1.82–3.10) | 2.24 (1.82–2.69) | < 0.0001 | 3.25 (2.64–3.80) | 2.20 (1.92–2.42) | < 0.0001 |
 P*** | 0.3946 | 0.0683 | 0.1178 | 0.5890 | 0.6870 | 0.3952 | 0.7561 | 0.5934 | 0.7648 |  | 0.1495 | 0.6241 |  |
LDL-C, median (IQR), | mmol/L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 3.10 (2.61–3.59) | 3.00 (2.23–3.47) | 3.08 (2.30–3.59) | 2.84 (2.33–3.41) | 3.15 (2.64–3.72) | 2.72 (2.15–3.36) | 3.13 (2.59–3.52) | 2.72 (1.97–3.65) | 2.92 (2.59–3.57) | 0.8679 | 3.10 (2.40–3.59) | 3.19 (2.74–3.70) | 0.0170 |
 Increased LDL-C group (group I) | 2.66 (2.02–3.21) | 2.66 (1.91–3.52) | 2.51 (1.71–3.13) | 3.21 (2.25–3.49) | 3.28 (2.72–4.19) | 3.10 (1.91–3.67) | 3.00 (2.46–3.75) | 3.31 (1.86–3.96) | 3.39 (2.87–4.09) | 0.0483 | 2.53 (1.96–3.26) | 3.31 (2.77–4.11) | < 0.0001 |
 No LDL-C increase group (group NI) | 3.26 (2.92–3.78) | 3.26 (2.82–3.47) | 3.52 (2.87–3.75) | 2.69 (2.33–2.84) | 2.92 (2.64–3.41) | 2.59 (2.22–3.05) | 3.15 (2.72–3.44) | 2.64 (2.28–3.21) | 2.74 (2.56–3.10) | 0.0157 | 3.36 (3.05–3.72) | 3.03 (2.66–3.44) | 0.0022 |
 P*** | 0.0024 | 0.0759 | 0.0008 | 0.4414 | 0.1583 | 0.4616 | 0.7042 | 0.8415 | 0.0603 |  | 0.0009 | 0.2418 |  |
HDL-C, median (IQR), | mmol/L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Total | 1.27 (1.01–1.45) | 1.22 (0.98–1.42) | 1.22 (1.01–1.42) | 1.22 (1.09–1.45) | 1.37 (1.16–1.53) | 1.42 (1.14–1.55) | 1.29 (1.06–1.47) | 1.22 (0.98–1.55) | 1.27 (1.01–1.55) | 0.5147 | 1.22 (1.03–1.40) | 1.32 (1.14–1.53) | < 0.0001 |
 Increased LDL-C group (group I) | 1.16 (0.93–1.37) | 1.22 (0.96–1.32) | 1.14 (0.85–1.32) | 1.14 (1.06–1.27) | 1.37 (1.06–1.50) | 1.37 (1.22–1.45) | 1.22 (0.91–1.50) | 1.19 (0.96–1.55) | 1.27 (1.03–1.66) | 0.2396 | 1.16 (0.93–1.29) | 1.29 (1.09–1.53) | < 0.0001 |
 No LDL-C increase group (group NI) | 1.29 (1.14–1.55) | 1.29 (1.03–1.58) | 1.32 (1.06–1.50) | 1.42 (1.11–1.47) | 1.37 (1.16–1.60) | 1.45 (0.98–1.71) | 1.34 (1.11–1.47) | 1.24 (1.09–1.55) | 1.29 (1.09–1.53) | 0.9936 | 1.32 (1.06–1.50) | 1.34 (1.14–1.55) | 0.0258 |
 P*** | 0.0465 | 0.1829 | 0.0194 | 0.1589 | 0.5368 | 0.9096 | 0.6165 | 0.8413 | 1.0000 |  | 0.0267 | 0.5090 |  |
Non − HDL-C, median | (IQR), | mmol/L |  |  |  |  |  |  |  |  |  |  |  |
 Total | 4.71 (4.37–5.15) | 4.55 (4.34–5.72) | 4.71 (4.27–5.43) | 3.52 (3.10–4.37) | 4.27 (3.52–4.78) | 3.80 (3.10–4.34) | 4.14 (3.72–4.45) | 4.03 (3.59–4.47) | 3.96 (3.62–4.31) | < 0.0001 | 4.84 (4.32–5.28) | 4.14 (3.52–4.58) | < 0.0001 |
 Increased LDL-C group (group I) | 4.73 (4.09–5.46) | 4.65 (3.98–6.52) | 4.55 (4.01–5.33) | 3.85 (3.26–4.76) | 4.45 (3.52–4.99) | 4.16 (3.28–4.53) | 3.98 (3.67–4.55) | 3.98 (3.57–4.78) | 4.06 (3.72–4.99) | 0.1581 | 4.86 (4.03–5.35) | 4.24 (3.41–4.84) | 0.0063 |
 No LDL-C increase group (group NI) | 4.71 (4.40–5.04) | 4.55 (4.34–5.59) | 4.84 (4.40–5.66) | 3.34 (2.82–3.70) | 4.19 (3.39–4.63) | 3.62 (2.84–3.98) | 4.22 (3.75–4.42) | 4.09 (3.08–4.34) | 3.75 (3.52–4.11) | < 0.0001 | 4.76 (4.45–5.20) | 4.06 (3.57–4.50) | < 0.0001 |
 P*** | 0.7853 | 0.9613 | 0.2362 | 0.2466 | 0.2472 | 0.3356 | 0.6662 | 0.8415 | 0.1653 |  | 0.6834 | 0.5220 |  |