Table 1.
Patients characteristics at randomization (Pre) and at the end of the treatment period (Post) according to study treatment
| Variable (unit) | Ezetimibe |
Placebo |
||
|---|---|---|---|---|
| Pre (n = 54) | Post (n = 53) | Pre (n = 54) | Post (n = 54) | |
| Clinical parameters | ||||
| BMI (kg/m2) | 29.0 ± 4.2 | 28.8 ± 4.3 | 28.8 ± 4.1 | 28.9 ± 4.1 |
| Systolic blood pressure (mmHg) | 136 ± 13 | 133 ± 13 | 131 ± 15 | 131 ± 15 |
| Diastolic blood pressure (mmHg) | 79 ± 7 | 78 ± 7 | 78 ± 8 | 77 ± 7 |
| Metabolic parameters | ||||
| Serum glucose (mg/dl) | 160 ± 44 | 168 ± 43 | 162 ± 50 | 159 ± 44 |
| HbA1C (%) | 5.8 ± 1.5 | 5.5 ± 1.2 | 5.5 ± 1.1 | 5.5 ± 1.2 |
| Renal function | ||||
| Serum creatinine (mg/dl) | 0.90 ± 0.18 | 0.91 ± 0.17 | 0.87 ± 0.20 | 0.88 ± 0.21 |
| Serum urea (mg/dl) | 42 ± 12 | 43 ± 12 | 39 ± 12 | 39 ± 11 |
| Urinary albumin excretion (μg/min) | 5.2 (2.8–10.3) | 4.7 (3.3–11.8) | 4.6 (3.4–7.2) | 4.7 (3.3–9.6) |
| Lipids | ||||
| Total cholesterol (mg/dl) | 162 ± 36 | 124 ± 30* | 154 ± 30 | 158 ± 32‡ |
| HDL cholesterol (mg/dl) | 48 ± 11 | 45 ± 12* | 50 ± 12 | 50 ± 11§ |
| LDL cholesterol (mg/dl) | 99 ± 31 | 66 ± 22* | 91 ± 28 | 94 ± 32‡ |
| LDL <70 mg/dl | 7 (13.0) | 38 (71.7)† | 14 (25.9) | 9 (16.7)†‡ |
| Triglycerides (mg/dl) | 123 ± 95 | 108 ± 77 | 106 ± 65 | 104 ± 62§ |
| Apolipoprotein A (mg/dl) | 134 ± 23 | 138 ± 27 | 139 ± 20 | 143 ± 23 |
| Apolipoprotein B (mg/dl) | 83 ± 22 | 64 ± 18* | 81 ± 23 | 81 ± 22‡ |
| Safety parameters | ||||
| Aspartate transaminase (IU/l) | 23 ± 7 | 24 ± 9 | 21 ± 5 | 21 ± 6 |
| Alanine transaminase (IU/l) | 25 ± 10 | 27 ± 10 | 23 ± 9 | 23 ± 8 |
| γ-Glutamyl transferase (IU/l) | 33 ± 39 | 35 ± 37 | 30 ± 30 | 29 ± 27 |
| Creatinine phosphokinase (IU/l) | 147 ± 140 | 143 ± 120 | 113 ± 60 | 115 ± 70 |
Data are means ± SD, medians (interquartile range), or n (%).
*P < 0.01 and
†P < 0.0001 vs. Pre (Bonferroni adjusted paired t test or McNemar χ2 test).
‡P < 0.0001 and
§0.05 vs. ezetimibe (ANCOVA or χ2 test).