Placebo (n=16) | Teduglutide 0.10 mg/kg/day (n=32) | p1 Value | Teduglutide 0.05 mg/kg/day (n=35) | p2 Value | |
SB villus height, μm | |||||
Baseline | n=9 | n=20 | 0.97 | n=17 | 0.65 |
428±119 | 427±102 | 410±83 | |||
Week 24 | n=7 | n=16 | 0.0004 | n=18 | 0.0008 |
347±74 | 593±145 | 600±166 | |||
Absolute change | n=4 | n=14 | 0.0024 | n=11 | 0.0065 |
−139±169 | 181±156 | 157±132 | |||
Relative change (%) | n=4 | n=14 | 0.0086 | n=11 | 0.024 |
−24.4±28.3 | 47.4±42.3 | 40.4±36.6 | |||
SB crypt depth, μm | |||||
Baseline | n=9 | n=20 | 0.03 | n=18 | 0.40 |
194±64 | 151±38 | 172±63 | |||
Week 24 | n=7 | n=17 | 0.017 | n=18 | 0.006 |
135±40 | 222±85 | 198±50 | |||
Absolute change | n=4 | n=15 | 0.008 | n=12 | 0.20 |
−27±12 | 87±80 | 16±66 | |||
Relative change (%) | n=4 | n=15 | 0.0026 | n=12 | 0.11 |
−17.5±7.7 | 64.4±52.1 | 17.8±35 | |||
Colon crypt depth, μm | |||||
Baseline | n=9 | n=22 | 0.89 | n=20 | 0.27 |
395±44 | 392±67 | 438±109 | |||
Week 24 | n=10 | n=17 | 0.008 | n=17 | 0.015 |
375±59 | 453±72 | 441±65 | |||
Absolute change | n=7 | n=17 | 0.022 | n=14 | 0.13 |
−3±64 | 66±85 | 9±106 | |||
Relative change (%) | n=7 | n=17 | 0.016 | n=14 | 0.14 |
−0.5±17.0 | 20.0±27.1 | 5.1±18.6 | |||
Plasma citrulline, μmol/l | |||||
Baseline | n=16 | n=32 | 0.051 | n=34 | 0.19 |
22.2±10.6 | 16.6±8.3 | 18.0±10.3 | |||
Week 24 | n=16 | n=29 | 0.09 | n=27 | 0.27 |
24.2±13.6 | 32.1±15.4 | 29.5±16.2 | |||
Absolute change | n=16 | n=29 | <0.0001 | n=26 | <0.0001 |
1.9±5.0 | 15.7±12.7 | 10.9±11.3 | |||
Relative change (%) | n=16 | n=29 | <0.0001 | n=26 | <0.0001 |
7.9±20.5 | 113.1±84.0 | 66.7±66.9 |
Values shown are mean±SD.
p1 and p2 values for treatment differences from a general linear model (GLM) method with dependent variable changes from baseline in corresponding variables, independent variable treatment and corresponding variables at baseline as covariates.