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 |