Table 3.
Bristol Stool Form Scale Score, Patient Satisfaction, and Symptoms of Constipation, Fecal Disimpaction, and Time to Bowel Movements After Treatment With Elobixibat
| Item | Baseline (n = 986) | Week 2 (n = 986) | Week 4 (n = 986) |
|---|---|---|---|
| Bristol Stool Form Scale score | 2.3 ± 1.4 (888) | 3.8 ± 1.3a (778) | 3.9 ± 1.1a (817) |
| Patient satisfaction | |||
| Satisfaction | 6 (0.7) | 222 (28.1) | 324 (38.9) |
| Slight satisfaction | 51 (5.6) | 300 (38.0) | 317 (38.1) |
| Slight dissatisfaction | 297 (32.7) | 164 (20.8) | 118 (14.2) |
| Dissatisfaction | 553 (61.0) | 103 (13.1) | 73 (8.8) |
| No evaluation | 79 (−) | 197 (−) | 154 (−) |
| Abdominal distension | |||
| No | 64 (7.2) | 175 (22.4) | 232 (28.3) |
| Rarely | 165 (18.7) | 309 (39.5) | 355 (43.2) |
| Occasionally | 326 (36.9) | 231 (29.5) | 193 (23.5) |
| Often | 229 (25.9) | 49 (6.3) | 28 (3.4) |
| Always | 99 (11.2) | 18 (2.3) | 13 (1.6) |
| No evaluation | 103 (−) | 204 (−) | 165 (−) |
| Straining during defecation, n (%) | |||
| No | 42 (4.9) | 148 (19.2) | 190 (23.5) |
| Rarely | 102 (11.9) | 289 (37.5) | 318 (39.3) |
| Occasionally | 266 (31.0) | 221 (28.7) | 212 (26.2) |
| Often | 278 (32.4) | 69 (8.9) | 55 (6.8) |
| Always | 171 (19.9) | 44 (5.7) | 34 (4.2) |
| No evaluation | 127 (−) | 215 (−) | 177 (−) |
| Fecal disimpaction | |||
| No | 805 (88.6) | 757 (95.9) | 803 (96.6) |
| Yes | 104 (11.4) | 32 (4.1) | 28 (3.4) |
| No evaluation | 77 (−) | 197 (−) | 155 (−) |
| Time to bowel movement (hr) | |||
| Mean ± SD (n) | ND | 6.1 ± 6.0 (415) | 6.4 ± 5.9 (439) |
| Median | 6.0 | 6.0 | |
aP < 0.001 vs baseline, Wilcoxon signed-rank test for Bristol Stool Form Scale score.
ND, not determined; n, number of patients with each item at each visit.
Data are presented as mean ± SD (n) or n (%).