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Table 1 Summary efficacy data from published Phase II trials with pemafibrate

From: Pemafibrate (K-877), a novel selective peroxisome proliferator-activated receptor alpha modulator for management of atherogenic dyslipidaemia

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   
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   
 [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   
  1. HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, TG triglycerides, T2DM type 2 diabetes mellitus
  2. ** p < 0.01, *** p < 0.001 versus control
  3. aTG ≥ 2.3 mmol/L (200 mg/dL) and low HDL-C
  4. bTG 1.9–5.7 mmol/L (175–500 mg/dL) and low HDL-C
  5. For both a and b, low HDL-C was defined as < 1.3 mmol/L (50 mg/dL) in men or < 1.4 mmol/L (55 mg/dL) in women
  6. cPatients with TG ≥ 1.7 mmol/L (150 mg/dL) at week 8 were uptitrated to 0.4 mg/day from week 12
  7. dSubgroup analysis of Kastelein et al. [61]