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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]