Table 3.
Group | Intention-to-treat
analysis |
Per-protocol analysis |
||||
---|---|---|---|---|---|---|
Routine treatment |
Orlistat | p | Routine treatment |
Orlistat | p | |
n | 102 | 68 | 76 | 54 | ||
Body mass index, kg/m2 | –0.4 ± 0.9 | –1.3 ± 1.4 | <0.001 | –0.5 ± 1.0 | –1.5 ± 1.4 | <0.001 |
Waist circumference, cm | –1.1 ± 2.8 | –4.6 ± 5.3 | <0.001 | –1.2 ± 2.9 | –4.5 ± 5.2 | <0.001 |
Bell circumference, cm | –1.1 ± 2.7 | –4.8 ± 5.4 | <0.001 | –1.1 ± 2.9 | –4.7 ± 5.1 | <0.001 |
SBP, mmHg | –1.2 ± 9.0 | –0.6 ± 15.5 | 0.75 | –1.1 ± 9.9 | 0.3 ± 16.4 | 0.57 |
DBP, mmHg | –0.1 ± 7.6 | –2.5 ± 13.1 | 0.14 | 0.0 ± 7.8 | –1.8 ± 12.9 | 0.32 |
Liver biochemistry | ||||||
ALT, U/l | –6.4 ± 20.5 | –15.1 ± 38.5 | 0.06 | –5.6 ± 20.2 | –16.5 ± 39.8 | 0.06 |
AST, U/l | –3.7 ± 8.4 | –7.0 ± 16.9 | 0.09 | –3.2 ± 7.8 | –8.3 ± 17.1 | 0.08 |
GGT, U/l | –9.5 ± 14.2 | –12.8 ± 23.8 | 0.31 | –8.6 ± 14.7 | –15.7 ± 26.0 | 0.07 |
ALP, U/l | –1.6 ± 8.6 | –10.8 ± 48.9 | 0.06 | –1.2 ± 9.7 | –5.4 ± 42.0 | 0.43 |
Metabolism | ||||||
Uric acid, μmol/l | –23.3 ± 63.8 | –25.2 ± 132.3 | 0.91 | –22.9 ± 58.4 | –12.3 ± 32.9 | 0.56 |
Cholesterol, mmol/l | –0.2 ± 0.9 | –0.5 ± 1.4 | 0.09 | –0.2 ± 0.7 | –0.4 ± 1.1 | 0.21 |
Triglyceride, mmol/l | –0.4 ± 1.3 | –0.1 ± 1.3 | 0.24 | –0.4 ± 1.5 | –0.1 ± 1.4 | 0.21 |
LDL-cholesterol, mmol/l | –0.5 ± 3.3 | –0.4 ± 0.9 | 0.84 | –0.6 ± 4.0 | –0.3 ± 0.8 | 0.63 |
Apolipoprotein -A, mmol/l | 0.0 ± 0.3 | –0.1 ± 0.3 | 0.20 | 0.0 ± 0.4 | 0.0 ± 0.2 | 0.51 |
Apolipoprotein -B, mmol/l | 0.0 ± 0.1 | –0.1 ± 0.3 | 0.06 | 0.0 ± 0.1 | 0.1 ± 0.2 | 0.11 |
Free fatty acid, mmol/l | –36.6 ± 150.4 | –95.1 ± 257.7 | 0.063 | –41.6 ± 159.5 | –88.3 ± 257.7 | 0.27 |
Fasting glucose, mmol/l | –0.2 ± 0.6 | –0.5 ± 1.5 | 0.07 | –0.2 ± 0.6 | –0.3 ± 1.2 | 0.42 |
HOMA-IR | –0.2 ± 1.2 | –0.6 ± 1.3 | 0.07 | –0.2 ± 1.3 | –0.7 ± 1.6 | 0.06 |
Pancreas fat content, % | ||||||
Head | –0.6 ± 1.9 | –0.2 ± 3.7 | 0.41 | –0.8 ± 2.1 | –0.2 ± 3.9 | 0.26 |
Body | –1.1 ± 1.5 | –0.3 ± 3.4 | 0.07 | –1.2 ± 1.5 | –0.3 ± 3.5 | 0.21 |
Tail | –0.8 ± 1.6 | 0.0 ± 3.2 | 0.06 | –1.0 ± 1.7 | 0.0 ± 3.3 | 0.21 |
ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase; DBP, diastolic blood pressure; GGT, gamma-glutamyl transferase; HOMA-IR, homeostasis model assessment of insulin resistance; LDL, low-density lipoprotein; SBP, systolic blood pressure.