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Table 3 Secondary and exploratory efficacy endpoints (modified intent-to-treat population)

From: Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China

Characteristics

IPE 4 g/day (n = 125)

IPE 2 g/day (n = 124)

Placebo (n = 124)

Placebo-corrected median change from baseline

 

Baseline Value

End-of-treatment Value

Change from baseline (%)

Baseline Value

End-of-treatment Value

Change from baseline (%)

Baseline Value

End-of-treatment Value

Change from baseline (%)

IPE 4 g/day vs. placebo (%, P Value)

IPE 2 g/day vs. placebo (%, P value)

VLDL-C (mmol/L)

(n = 121, 124, 123)

2.850 (1.610)

2.170 (1.560)

 − 17.20 (62.00)

2.750 (1.985)

2.875 (2.345)

 − 5.50 (77.60)

3.030 (1.660)

3.290 (2.290)

9.60 (65.00)

 − 27.85, < 0.001

 − 12.75, 0.059

LDL-C (mmol/L)

(n = 121, 124, 123)

1.430 (1.170)

1.650 (1.360)

11.80 (88.60)

1.290 (1.170)

1.755 (1.625)

25.20 (93.60)

1.350 (1.050)

1.460 (1.150)

3.80 (71.50)

4.85, 0.475

14.80, 0.065

Non–HDL-C (mmol/L)

(n = 121, 124, 123)

4.690 (1.440)

4.260 (1.410)

 − 6.60 (32.50)

4.785 (1.900)

4.900 (2.050)

5.25 (32.55)

4.690 (1.490)

5.020 (1.860)

8.80 (33.50)

 − 14.55, < 0.001

 − 3.45, 0.284

VLDL-TG (mmol/L)

(n = 121, 123,123)

6.870 (5.880)

4.630 (4.510)

 − 25.50 (63.70)

6.890 (6.920)

6.300 (7.380)

 − 12.00 (84.60)

6.720 (5.680)

6.760 (6.920)

3.20 (83.80)

 − 25.15, < 0.001

 − 12.55, 0.114

  1. Data are shown as the median (interquartile range) for endpoint values
  2. Abbreviations: TG triglyceride, non-HDL-C non-high-density lipoprotein cholesterol, VLDL-C very low-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, VLDL-TG very low-density lipoprotein-triglycerides