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Table 4 Absolute change in lipid and apolipoprotein parameters at week 12, week 24, and week 56 from baseline

From: Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Efficacy outcome

Laboratory assessment at study time point

Saroglitazar

2 mg (n = 192)

m ± SD

Saroglitazar

4 mg (n = 206)

m ± SD

Pioglitazone 30 mg (n = 206)

m ± SD

TG (mg/dL)

Absolute change at week 12

− 24.46 ± 91.48*

− 37.85 ± 119.74*

− 12.43 ± 104.28

Absolute change at week 24

− 17.20 ± 125.30

− 40.09 ± 144.91*

− 18.81 ± 99.43*

Absolute change at week 56

− 15.48 ± 117.09

− 28.19 ± 140.34*

− 17.16 ± 112.18*

LDL-C (mg/dL)

Absolute change at week 12

− 8.62 ± 33.82*

− 3.14 ± 37.62

− 2.97 ± 33.59

Absolute change at week 24

− 10.11 ± 42.06*

− 12.49 ± 38.99*

− 5.60 ± 37.84*

Absolute change at week 56

− 9.99 ± 45.25*

− 8.07 ± 42.08*

− 8.90 ± 40.80*

VLDL-C (mg/dL)

Absolute change at week 12

− 4.89 ± 18.30*

− 7.57 ± 23.95*

− 2.49 ± 20.86

Absolute change at week 24

− 3.44 ± 25.06

− 8.02 ± 28.98*

− 3.76 ± 19.89*

Absolute change at week 56

− 3.10 ± 23.42

− 5.64 ± 28.07*

− 3.43 ± 22.44*

HDL-C (mg/dL)

Absolute change at week 12

2.29 ± 11.61*

2.69 ± 10.35*

1.81 ± 12.85*

Absolute change at week 24

2.23 ± 12.83*

0.92 ± 10.69

2.11 ± 13.65*

Absolute change at week 56

2.15 ± 12.44*

1.98 ± 13.10*

2.09 ± 14.20*

TC (mg/dL)

Absolute change at week-12

− 8.30 ± 39.46*

− 6.00 ± 40.71*

− 0.47 ± 37.55

Absolute change at week 24

− 6.31 ± 48.48

− 12.67 ± 42.22*

− 1.28 ± 44.83

Absolute change at week 56

− 5.87 ± 54.19

− 6.43 ± 51.11

− 3.88 ± 46.01

Non HDL-C (mg/dL)

Absolute change at week 12

− 10.65 ± 39.28*

− 8.70 ± 41.20*

− 2.28 ± 38.09

Absolute change at week 24

− 8.57 ± 46.30*

− 13.61 ± 41.83*

− 3.42 ± 44.69

Absolute change at week 56

− 8.07 ± 53.57*

− 8.39 ± 51.01*

− 5.94 ± 45.66

Apo A1 (mg/dL)

Absolute change at week 12

0.24 ± 26.08

1.81 ± 24.18

− 1.40 ± 26.15

Absolute change at week 24

− 1.81 ± 27.59

− 3.46 ± 25.00

− 3.17 ± 27.41

Absolute change at week 56

1.37 ± 25.83

− 0.52 ± 27.09

0.63 ± 27.19

Apo B (mg/dL)

Absolute change at week 12

− 7.42 ± 27.91*

− 5.04 ± 27.38*

− 3.81 ± 23.38

Absolute change at week 24

− 3.76 ± 31.84

− 7.66 ± 26.80*

− 2.83 ± 26.88

Absolute change at week 56

− 0.63 ± 36.57

− 1.51 ± 32.05

− 1.97 ± 27.74

  1. Absolute change at week 12 = value at week 12 − value at baseline
  2. Absolute change at week 24 = value at week 24 − value at baseline
  3. Absolute change at week 56 = value at week 56 − value at baseline
  4. Apo apolipoprotein A1, Apo B apolipoprotein B, dL decilitre, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, mg milligram, m mean, n number of patients in each treatment group, SD standard deviation, TC total cholesterol, TG triglyceride, VLDL-C very low-density lipoprotein cholesterol
  5. * Significant difference compared to baseline using paired t-test (p value < 0.05 which is < 0.016 for each treatment group)