Table 1.
Patient demographics and baseline SBS characteristics.
| Parameter | RCT teduglutide group, n = 109 | RCT/extension teduglutide group, n = 173 | RCT placebo group, n = 59 |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 59 (54.1) | 95 (54.9) | 33 (55.9) |
| Age, mean (SD), years | 49.7 (13.5) | 49.8 (14.0) | 49.6 (15.4) |
| Reason for major intestinal resection, n (%) | |||
| Crohn’s disease | 33 (30.3) | 47 (27.2) | 15 (25.4) |
| Vascular disease | 35 (32.1) | 55 (31.8) | 19 (32.2) |
| Injury | 9 (8.3) | 13 (7.5) | 5 (8.5) |
| Volvulus | 9 (8.3) | 21 (12.1) | 8 (13.6) |
| Cancer | 1 (0.9) | 3 (1.7) | 2 (3.4) |
| Other | 19 (17.4) | 34 (19.7) | 10 (16.9) |
| Stoma present, n (%) | 45 (41.3) | 68 (39.3) | 22 (37.3) |
| Stoma type, n (%)† | |||
| Jejunostomy | 21 (46.7) | 31 (45.6) | 9 (40.9) |
| Ileostomy | 15 (33.3) | 23 (33.8) | 10 (45.5) |
| Colostomy | 9 (20.0) | 12 (17.6) | 1 (4.5) |
| Other | 0 | 2 (2.9) | 2 (9.1) |
| Colon-in-continuity, n (%) | 70 (64.2) | 109 (63.0) | 34 (57.6) |
| % Colon remaining, mean (SD) | 64.9 (23.1)‡ | 65.9 (24.9)§ | 69.3 (25.3)¶ |
| Patients with >50% colon-in-continuity, n (%) | 56 (51.4) | 89 (81.7) | 30 (50.8) |
| Estimated length of small intestine remaining, mean (SD), cm | 72.2 (53.8)|| | 68.0 (50.7)# | 71.0 (60.8)∆ |
| <60 cm, n (%) | 44 (45.4) | 80 (51.6) | 31 (56.4) |
| ⩾60 cm, n (%) | 53 (54.6) | 75 (48.4) | 24 (43.6) |
| Distal/terminal ileum present, n (%) | 24 (22.4) | 43 (25.1) | 17 (28.8) |
| Ileocecal valve present, n (%) | 11 (45.8) | 22 (51.2) | 11 (64.7) |
RCT, randomized controlled trial; SBS, short bowel syndrome.
†
Percentages calculated based on number of patients with a stoma, ‡n = 69, §n = 113, ¶n = 36, ||n = 97, #n = 155, ∆n = 55.