Table 3.
Changes in Anthropometric and Biochemical Variable Between the Colesevelam- Versus Placebo-Treated Patients
| Colesevelam (n=25) | Placebo (n=23) | Difference | |||||
|---|---|---|---|---|---|---|---|
| Baseline | Posttreatment | P-Value | Baseline | Posttreatment | P-Value | (P-Value) | |
| Weight (kg) | 89.6 (19.2) | 89.3 (18.9) | 0.539 | 89.2 (20.8) | 88.4 (19.9) | 0.139 | 0.43 (0.605) |
| BMI (kg/m2) | 31.3 (4.8) | 31.2 (4.6) | 0.545 | 31.7 (5.0) | 31.3 (4.7) | 0.128 | 0.25 (0.427) |
| ALT | 86.6 (68.1) | 109 (62.2) | 0.084 | 78.9 (50.0) | 65.2 (57.6) | 0.052 | 36.1 (0.016) |
| AST | 56.2 (46.3) | 62.8 (33.7) | 0.512 | 50.5 (33.5) | 43.8 (36.0) | 0.133 | 13.3 (0.238) |
| AST/ALT | 0.7 (0.2) | 0.6 (0.2) | 0.075 | 0.68 (0.3) | 0.72 (0.3) | 0.167 | −0.10 (0.025) |
| Glucose | 105.0 (24.7) | 102.8 (24.0) | 0.444 | 113.6 (33.6) | 112.9 (28.8) | 0.903 | −1.4 (0.826) |
| Insulin | 27.1 (40.2) | 32.7 (52.8) | 0.243 | 28.5 (28.1) | 32.5 (33.4) | 0.588 | −1.76 (0.831) |
| Hgb A1C | 6.1 (0.8) | 6.0 (0.8) | 0.664 | 6.4 (1.0) | 6.5 (1.0) | 0.618 | −0.12 (0.510) |
| Triglycerides | 198.0 (150.3) | 203.6 (73.8) | 0.942 | 168.3 (76.7) | 172.2 (88.5) | 0.549 | −4.75 (0.860) |
| Total Cholesterol | 200.2 (46.0) | 187.3 (35.1) | 0.076 | 201.5 (37.7) | 200.6 (43.2) | 0.512 | −12.7 (0.098) |
| LDL | 119.1 (44.5) | 106 (33.4) | 0.002 | 116.7 (32.4) | 111.8 (38.5) | 0.241 | −15.33 (0.021) |
| FFA | 0.5 (0.2) | 0.5 (0.2) | 0.387 | 0.5 (0.2) | 0.5 (0.2) | 0.293 | 0.10 (0.190) |
| Alk Phos | 79.3 (26.1) | 87.4 (30.5) | 0.004 | 77.5 (18.7) | 76.7 (19.2) | 0.624 | 8.99 (0.006) |
| GGT | 66.4 (38.2) | 99.5 (84.5) | 0.009 | 84.7 (83.5) | 87.4 (106.3) | 0.665 | 30.8 (0.028) |
| Total Bilirubin | 0.7 (0.5) | 0.7 (0.5) | 1.00 | 0.5 (0.2) | 0.5 (0.2) | 1.00 | 0.00 (1.00) |
| Direct Bilirubin | 0.1 (0.1) | 0.2 (0.1) | 0.047 | 0.1 (0.0) | 0.1 (0.0) | 0.575 | 0.032 (0.109) |
| Albumin | 4.6 (0.3) | 4.6 (0.3) | 0.643 | 4.6 (0.3) | 4.6 (0.3) | 0.648 | 0.00 (0.978) |
| Protime | 11.5 (0.7) | 11.5 (1.4) | 0.913 | 11.4 (0.7) | 11.3 (0.9) | 0.390 | 0.085 (0.773) |
| HOMA-IR | 7.6 (12.3) | 8.4 (12.9) | 0.609 | 8.7 (10.1) | 10.0 (12.8) | 0.542 | −0.73 (0.776) |
Data are expressed as means with standard error in parentheses or mean difference with P-value in parentheses.
BMI, Body Mass Index; AST, Aspartate Aminotransferase; ALT, Alanine Aminotransferase; Hgb A1c, hemoglobin A1c; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; FFA, Free Fatty Acids; Alk Phos, Alkaline Phosphatase; GGT, Gamma-Glutamyl Transferase; HOMA, homeostatic model assessment; CRP, C-Reactive Protein.
Independent sample ttest assuming equal variance was performed on all continuous variables for comparisons between groups. Paired-sample t test was performed for comparisons within group. Mean differences reflect comparison between baseline averages minus posttreatment averages.