TABLE 1.
Changes during Period 1 versus Period 2 (two sample statistics) and changes during atorvastatin period alone (one sample statistics)
| Mean ± SD at study entry | Primary analysis Two sample statistics | Secondary analysis One sample statistics | |||
|---|---|---|---|---|---|
| (n = 49 baseline) | Point estimate of atorvastatin effect (SE) (n = 44) | Two sample p value | Point estimate of atorvastatin effect ± SD (n = 45) | One sample p value | |
| AI75 (%) | 4.37 ± 13 | -2.18 (2.14) | 0.32 | -2.0 ± 7.0 | 0.06 |
| RH-PAT | 1.77 ± 0.5 | -0.11 (0.14) | 0.43 | -0.03 ± 0.5 | 0.75 |
| HbA1c (%) | 8.3 ± 1.2 | 0.30 (0.27) | 0.27 | 0.18 ± 1.0 | 0.23 |
| Total cholesterol (mmol/l) | 4.27 ± 1.0 | -1.06 (0.17) | <0.001 | -0.77 ± 0.63 | <0.001 |
| LDL-cholesterol (mmol/l) | 2.25 ± 0.7 | -1.14 (0.15) | <0.001 | -0.74 ± 0.52 | <0.001 |
| LDL-cholesterol change (%) | -31 ± 18.7 | <0.001 | |||
| HDL-cholesterol (mmol/l) | 1.6 ± 0.35 | 0.076 (0.057) | 0.19 | 0.0026 ± 0.2 | 0.92 |
| Triglycerides (mmol/l) | 0.94 ± 0.59 | 0.018 (0.1) | 0.86 | 0.07 ± 0.4 | 0.27 |
| Glucose (mmol/l) | 10.82 ± 4.7 | 1.95 (1.65)# | 0.24 | 1.22 ± 6.2 | 0.20 |
| AST (U/l) | 20 ± 8.4 | 2.4 (1.9)† | 0.21 | 1.1 ± 4.6‡ | 0.12 |
| ALT (U/l) | 15 ± 5.5 | 4.3 (1.3)† | 0.002 | 2.8 ± 5.7‡ | 0.002 |
| Urine microalbumin/creatinine (mg/g) | 4 ± 5.9 | 19.3 (27.2)* | 0.48 | 25.1 ± 173* | 0.34 |
| BMI | 22.6 ± 4.3 | -0.29 (0.21) | 0.15 | -0.1 ± 0.8 | 0.39 |
| BMI percentile | 67.9 ± 25.8 | -2.52 (2.55) | 0.33 | -2.0 ± 9.9 | 0.17 |
| Average systolic BP (mm Hg) | 105 ± 9.9 | 3.50 (2.50) | 0.17 | 3.1 ± 10.0 | 0.04 |
| Average diastolic BP (mm Hg) | 67 ± 9.7 | -1.41 (2.48) | 0.57 | -0.8 ± 10.0 | 0.62 |
| Heart rate (beats/min) | 75 ± 15.2 | 1.23 (2.72) | 0.65 | ||
Mean value at study entry, point estimate of atorvastatin effect, and p value for major study endpoints using the primary analysis (two sample statistics of the change during period 1 versus change during period 2). Also shown are point estimates of atorvastatin effect ± SD and p value using one sample statistics (secondary analysis). Negative point estimates suggest lower values following the atorvastatin treatment period.
Outlier prone variable
n = 42
n = 43
n = 44.
To convert cholesterol values from mmol/l to mg/dl multiply by 38.67. To convert triglycerides from mmol/l to mg/dl multiply by 88.6.
AI75 = augmentation index corrected to heart rate of 75; RH-PAT = reactive hyperemia peripheral artery tonometry; SD = standard deviation; SE = standard error.