Table 3.
Change From Baseline in Efficacy Variable at Week 24 (Modified Intention-to-Treat Population, Last Observation Carried Forward Method).
| Saroglitazar |
||||
|---|---|---|---|---|
| Efficacy parameter | Analysis | 2 mg (n = 37) | 4 mg (n = 39) | Pioglitazone 45 mg (n = 33) |
| Triglyceride (mg/dL) | Baseline mean ± SD | 253.9 ± 68.44 | 257.0 ± 52.39 | 265.0 ± 61.66 |
| Absolute change LSM ± SD | −78.2 ± 81.98# | −115.4 ± 68.11* # | −33.3 ± 162.41 | |
| Percentage change LSM ± SD | −26.4 ± 31.57# | −45.0 ± 24.78* # | −15.5 ± 54.40 | |
| LDL cholesterol direct (mg/dL) | Baseline mean ± SD | 134.8 ± 42.56 | 130.8 ± 38.83 | 116.6 ± 29.25 |
| Absolute change LSM ± SD | 3.6 ± 40.07 | −12.0 ± 39.38* # | 3.5 ± 23.17# | |
| Percentage change LSM ± SD | 12.2 ± 52.64 | −5.0 ± 30.36 | 4.8 ± 22.58 | |
| VLDL cholesterol (mg/dL) | Baseline mean ± SD | 50.3 ± 14.17 | 52.4 ± 12.35 | 55.1 ± 18.78 |
| Absolute change LSM ± SD | −15.2 ± 16.86# | −23.9 ± 15.26* # | −8.8 ± 24.81# | |
| Percentage change LSM ± SD | −25.1 ± 32.93 | −45.5 ± 25.12* | −20.0 ± 41.02 | |
| Total cholesterol (mg/dL) | Baseline mean ± SD | 202.4 ± 47.60 | 197.3 ± 40.98 | 185.8 ± 29.91 |
| Absolute change LSM ± SD | 2.5 ± 43.49 | −18.5 ± 40.62* # | 9.1 ± 28.77# | |
| Percentage change LSM ± SD | 5.0 ± 29.87 | −7.7 ± 20.00* | 5.5 ± 16.52 | |
| HDL cholesterol (mg/dL) | Baseline mean ± SD | 36.8 ± 12.09 | 35.3 ± 9.64 | 38.3 ± 10.85 |
| Absolute change LSM ± SD | 2.8 ± 11.27 | 0.2 ± 7.78 | 2.0 ± 6.86 | |
| Percentage change LSM ± SD | 12.7 ± 32.30 | 3.8 ± 22.11 | 7.1 ± 15.91 | |
| APo-A1 (mg/dL) | Baseline mean ± SD | 129.4 ± 36.64 | 138.0 ± 30.07 | 137.2 ± 23.69 |
| Absolute change LSM ± SD | 20.3 ± 58.79# | −2.3 ± 49.55 | 7.2 ± 54.86 | |
| Percentage change LSM ± SD | 27.6 ± 69.18 | 2.7 ± 38.86 | 10.0 ± 50.68 | |
| Apo-lipoproteins B (mg/dL) | Baseline mean ± SD | 101.3 ± 26.77 | 98.3 ± 24.96 | 89.3 ± 18.02 |
| Absolute change LSM ± SD | −5.4 ± 29.96 | −13.4 ± 23.41# | −6.4 ± 22.40 | |
| Percentage change LSM ± SD | 2.9 ± 46.79 | −10.9 ± 22.32 | −4.8 ± 28.90 | |
| Fasting plasma glucose (mg/dL) | Baseline mean ± SD | 143.9 ± 42.35 | 152.7 ± 65.99 | 138.2 ± 31.94 |
| Absolute change LSM ± SD | −11.3 ± 50.11 | −22.6 ± 66.30# | −21.8 ± 46.24 | |
| Percentage change LSM ± SD | −1.5 ± 39.42 | −8.3 ± 31.91 | −12.8 ± 30.06 | |
| HbA1c (%) | Baseline mean ± SD | 8.1 ± 0.86 | 7.9 ± 0.58 | 8.2 ± 0.75 |
| Absolute change LSM ± SD | −0.3 ± 0.83# | −0.3 ± 0.60# | −0.4 ± 0.72# | |
Abbreviations: dL, deciliter; LOCF, last observation carried forward; LSM, least square mean; mg, milligram; SD, standard deviation; SE, standard error.
*
Significant compared to pioglitazone. #Significant compared to baseline.