Table 1.
Baseline characteristics of SBS–IF patients in the STEPS trial
| Characteristics | Teduglutide (n=43) |
Placebo (n=43) |
P-value |
|---|---|---|---|
| Demographics | |||
| Age (years), mean (SD) | 50.9 (12.6) | 49.7 (15.6) | 0.82 |
| Male, n (%) | 21 (48.8) | 19 (44.2) | 0.67 |
| White, n (%) | 42 (97.7) | 41 (95.3) | 1.00 |
| Baseline SBS characteristics | |||
| Cause of major intestinal resection, n (%) | |||
| Crohn’s disease | 10 (23.3) | 8 (18.6) | 0.60 |
| Vascular disease | 13 (30.2) | 16 (37.2) | 0.49 |
| Injury | 4 (9.3) | 4 (9.3) | 1.00 |
| Volvulus | 3 (7.0) | 6 (14.0) | 0.48 |
| Cancer | 1 (2.3) | 2 (4.7) | 1.00 |
| Other | 12 (27.9) | 7 (16.3) | 0.19 |
| Presence of stoma, n (%) | 21 (48.8) | 17 (39.5) | 0.39 |
| Percentage of colon remaining, mean (SD) | 33.9 (31.8) | 40.9 (40.6) | 0.39 |
| Presence of distal/terminal ileum, n (%) | 10 (23.3) | 14 (32.6) | 0.34 |
| Presence of ileocecal valve, n (%) | 3 (7.0) | 10 (23.3) | 0.04* |
| Baseline PS characteristics | |||
| Baseline PS volume at randomization, n (%) | 0.78 | ||
| ≤6 L/week | 8 (18.6) | 7 (16.3) | |
| >6 L/week | 35 (81.4) | 36 (83.7) | |
| Time since start of PS dependency (years), mean (SD) | 6.8 (6.3) | 5.9 (5.7) | 0.76 |
| Concomitant narcotics use, n (%) | 15 (34.9) | 12 (27.9) | 0.49 |
Note:
*
P<0.05.
Abbreviations: PS, parenteral support; SBS, short bowel syndrome; SBS–IF, SBS with intestinal failure; STEPS, Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects.