Table 2.
Safety profile of lubiprostone compared in chronic constipation and IBS-C in phase II and phase III trials
| Symptom | Placebo *CC N = 346 (%) | Lubiprostone 24 μg twice daily N = 1113 (%) | Placebo **IBS N = 435 (%) | Lubiprostone 8 μg twice daily N = 1011 (%) |
|---|---|---|---|---|
| Nausea | 16 (5.1) | 346 (31.1) | 17 (4) | 81 (8) |
| Diarrhea | 3 (0.9) | 147 (13.2) | 17 (4) | 71 (7) |
| Headache | 21 (6.6) | 147 (13.2) | No reported | Not reported |
| Abdominal distention | 9 (2.2) | 79 (7.1) | 22 (5) | 50 (5) |
| Abdominal pain | 7 (2.8) | 75 (6.7) | 9 (2) | 30 (3) |
| Flatulence | 6 (1.9) | 68 (6.1) | Not reported | Not reported |
| Vomiting | 3 (0.9) | 51(4.6) | Not reported | Not reported |
| Dizziness | 4 (1.3) | 46 (4.1) | Not reported | Not reported |