Citation no. | Patients | N | Dose (mg/day) | Weeks | Mean ∆ in TG (%) | Mean ∆ in HDL-C (%) |
---|---|---|---|---|---|---|
Monotherapy | ||||||
 [56] | Japanese patients with atherogenic dyslipidaemiaa | 224 | Pemafibrate | 12 |  |  |
0.05 | ↓30.9 ± 6.9*** | ↑11.9 ± 2.8*** | ||||
0.1 | ↓36.4 ± 6.6*** | ↑16.5 ± 2.7*** | ||||
0.2 | ↓42.6 ± 6.7*** | ↑16.3 ± 2.8*** | ||||
0.4 | ↓42.7 ± 6.7*** | ↑21.0 ± 2.8*** | ||||
Fenofibrate | Â | Â | ||||
100 | ↓29.7 ± 6.7 | ↑14.3 ± 2.8 | ||||
Placebo | ↑28.5 ± 6.8 | ↓2.3 ± 2.8 | ||||
 [63] | Japanese patients with atherogenic dyslipidaemiaa | 526 | Pemafibrate | 12 |  | ↑20.3–24.7 |
0.1 | ↓46.3*** |  | ||||
0.2 | ↓46.7*** |  | ||||
0.4 | ↓51.8*** |  | ||||
Fenofibrate |  | ↑17.2–26.5 | ||||
100 | ↓38.3*** |  | ||||
200 | ↓51.5*** |  | ||||
Placebo | ↓2.7 |  | ||||
Add-on to statin | ||||||
 [60] | Japanese patients with TG ≥ 2.3 mmol/L | 423 | Pemafibrate | 24 |  |  |
0.2 | ↓46.8 ± 2.6*** | ↑17.6 ± 17.2*** | ||||
0.2/0.4c | ↓50.8 ± 2.5*** | ↑16.3 ± 14.6*** | ||||
Placebo | ↓0.8 ± 3.0 | ↑4.4 ± 12.7 | ||||
 [60] | Add-on to pitavastatin Japanese patients with TG ≥ 2.3 mmol/L, non-HDL-C ≥ 3.9 mmol/L | 188 | Pemafibrate | 12 |  |  |
0.1 | ↓46.1 ± 3.9*** | ↑13.6 ± 15.4** | ||||
0.2 | ↓53.4 ± 3.8*** | ↑19.7 ± 19.4*** | ||||
0.4 | ↓52.0 ± 3.9*** | ↑12.7 ± 19.3* | ||||
Placebo | ↓6.9 ± 4.0 | ↑3.4 ± 12.5 | ||||
 [59] | T2DM and dyslipidemia Japanese patients with TG ≥ 1.7 and < 11.3 mmol/L | 167 | Pemafibrate | 24 |  |  |
0.2 | ↓44.3*** | |||||
0.4 | ↓45.1*** | |||||
Placebo | ↓10.8*** | |||||
 [61] | Caucasian patients, controlled LDL-C and atherogenic dyslipidaemiab | 408 | Pemafibrate | 12 | ↓34.0–54.4*** | ↑7.4–12.9*** |
0.1, 0.2 or 0.4 | Â | Â | ||||
 [62] | Caucasian type 2 diabetes patients with controlled LDL-C and atherogenic dyslipidaemiab | 161d | Pemafibrate | 12 | ↓44.7–67.4*** | NR |
0.1, 0.2 or 0.4 | Â | Â |