Placebo (n=16) | Teduglutide 0.10 mg/kg/day (n=32) | Teduglutide 0.05 mg/kg/day (n=35) | Overall (n=83) | p Value | |
Age (years), mean (SD) | 49.4 (15.1) | 50.3 (14.0) | 47.1 (14.2) | 48.8 (14.2) | 0.64† |
N | 16 | 32 | 35 | 83 | |
Range | (20–72) | (19–79) | (20–68) | (19–79) | |
BMI (kg/m2), mean (SD) | 22.0 (2.9) | 21.7 (2.6) | 21.2 (3.0) | 21.5 (2.8) | |
N | 16 | 32 | 35 | 83 | 0.60† |
Range | (17.4–28.4) | (17.0–26.4) | (15.6–26.7) | (15.6–28.4) | |
Female sex, n (%) | 9 (56.3%) | 19 (59.4%) | 18 (51.4%) | 46 (55.4%) | 0.81* |
Cause of major intestinal resection, n (%) | 0.81* | ||||
Crohn's disease | 7 (44%) | 13 (41%) | 10 (29%) | 30 (36%) | |
Vascular disease | 3 (19%) | 8 (25%) | 14 (40%) | 25 (30%) | |
Injury | 1 (6%) | 2 (6%) | 3 (9%) | 6 (7%) | |
Volvulus | 2 (13%) | 4 (13%) | 5 (14%) | 11 (13%) | |
Other | 3 (19%) | 5 (16%) | 3 (9%) | 11 (13%) | |
Patients in whom the intestinal anatomy or remnant small bowel length was unknown | 0 | 2 | 1 | 3 | |
Jejunostomy/ileostomy, n | 0.22* | ||||
Ileostomy | 1 | 7 | 2 | 10 | |
Jejunostomy | 4 | 4 | 6 | 14 | |
Colon in continuity, n (%) | 11 (69%) | 19 (59%) | 26 (74%) | 56 (68%) | |
Overall remnant small bowel length, cm | 0.40† | ||||
N | 15 | 27 | 31 | 73 | |
Mean (SD) | 77 (53) | 68 (43) | 58 (44) | 66 (45) | |
Median | 60 | 60 | 50 | 60 | |
Range | (15–200) | (10–200) | (6–200) | (6–200) | |
Remnant small bowel length in patients with jejunostomy/ileostomy, cm | 0.19† | ||||
N | 4 | 8 | 7 | 19 | |
Mean (SD) | 144 (52) | 77 (60) | 105 (54) | 101 (59) | |
Median | 150 | 52 | 80 | 75 | |
Range | (75–200) | (30–200) | (60–200) | (30–200) | |
Remnant small bowel length in patients with colon in continuity, cm | 0.15† | ||||
N | 11 | 17 | 24 | 52 | |
Mean (SD) | 53 (26) | 62 (27) | 45 (29) | 52 (28) | |
Median | 50 | 60 | 40 | 50 | |
Range | (15–110) | (10–120) | (6–125) | (6–125) | |
Remnant colon, n (%) | 0.76* | ||||
>25–50% colon remnant | 4 (36%) | 8 (42%) | 7 (27%) | 19 (34%) | |
>50–75% colon remnant | 4 (36%) | 4 (21%) | 9 (35%) | 17 (30%) | |
>75–100% colon remnant | 3 (27%) | 7 (37%) | 10 (39%) | 20 (36%) | |
Time on parenteral support, years | 0.79† | ||||
N | 16 | 32 | 35 | 83 | |
Mean (SD) | 7.9 (7.5) | 7.3 (5.9) | 6.6 (6.5) | 7.1 (6.4) | |
Range | (1–23) | (1–24) | (1–24) | (1–24) | |
Parenteral volume, ml/day | 0.11† | ||||
N | 16 | 32 | 34 | 82 | |
Mean (SD) | 1531 (874) | 1816 (1008) | 1374 (639) | 1577 (859) | |
Range | (742–3850) | (470–4643) | (333–2500) | (333–4643) | |
Parenteral energy, kJ/day | |||||
N | 16 | 32 | 35 | 83 | 0.046† |
Mean (SD) | 3385 (2591) | 5296 (2845) | 3992 (2689) | 4378 (2805) | |
Range | (0–9984) | (0–13749) | (0–11514) | (0–13749) | |
Number of patients in parenteral type stratification | 0.52‡ | ||||
Type group 1, n (%) | 4 (25%) | 3 (9%) | 8 (23%) | 15 (18%) | |
(No with 3/4/5/6/7 days PS/week) | (1/0/0/2/1) | (0/0/1/0/2) | (1/2/0/1/4) | (2/2/1/3/7) | |
Type group 2, n (%) | 8 (50%) | 18 (56%) | 19 (54%) | 45 (54%) | |
(No with 3/4/5/6/7 days PS/week) | (2/4/1/0/1) | (3/5/6/4/0) | (5/7/6/0/0) | (10/16/13/4/1) | |
Type group 3, n (%) | 4 (25%) | 11 (34%) | 8 (23%) | 23 (28%) | |
(No with 3/4/5/6/7 days PS/week) | (0/0/0/0/4) | (0/0/0/2/9) | (0/0/0/0/8) | (0/0/0/2/21) | |
Number of patients in parenteral volume stratification | 0.43‡ | ||||
Parenteral volume 0–7 l/week, n (%) | 6 (38%) | 9 (28%) | 14 (40%) | 29 (35%) | |
(No with 3/4/5/6/7 days PS/week) | (2/3/0/1/0) | (3/5/0/1/0) | (5/6/0/0/2) | (10/14/0/2/3) | |
Parenteral volume 7–14 l/week, n (%) | 6 (38%) | 13 (41%) | 11 (31%) | 30 (36%) | |
(No with 3/4/5/6/7 days PS/week) | (1/1/1/0/3) | (0/0/6/5/2) | (1/2/5/1/2) | (2/3/12/6/7) | |
Parenteral volume 14–21 l/week, n (%) | 3 (19%) | 6 (19%) | 9 (26%) | 18 (22%) | |
(No with 3/4/5/6/7 days PS/week) | (0/0/0/1/2) | (0/0/1/0/5) | (0/1/1/0/7) | (0/1/2/1/14) | |
Parenteral volume >21 l/week, n (%) | 1 (6%) | 4 (13%) | 0 (0%) | 5 (6%) | |
(No with 3/4/5/6/7 days PS/week) | (0/0/0/0/1) | (0/0/0/0/4) | (0/0/0/0/0) | (0/0/0/0/5) | |
Concomitant medication | |||||
Antidiarrhoeal agents, n (%) | 8 (50%) | 19 (59%) | 22 (63%) | 49 (59%) | |
Antisecretory agents, n (%) | 7 (44%) | 17 (53%) | 19 (54%) | 43 (52%) |
↵* p Value based on the χ2contingency table using the exact method.
↵† p Value calculated using the general linear model (GLM) method with corresponding variables as dependent variables and treatment group as the independent variable.
↵‡ p Values for overall treatment comparisons based on the Fisher exact test for categorical variables and on a one-way ANOVA with effect for treatment for continuous variables.
Parenteral type group 1: parenteral support consisting of intravenous fluids and electrolytes only (3–7 times weekly); parenteral type group 2: parenteral nutrition 3–5 times weekly; parenteral type group 3: parenteral nutrition 6–7 times weekly.
PS, parenteral support.