TABLE.
Gastrointestinal TEAEs Reported in the ROADMAP Database
| Event | No. (%) of patients |
P value | |
|---|---|---|---|
| Olmesartan, 40 mg (n=2232) | Placebo (n=2215) | ||
| Intestinal-associated TEAE | 78 (3.5) | 94 (4.2) | .20 |
| Diarrhea | 51 (2.3) | 52 (2.3) | |
| Gastroenteritis | 17 (0.8) | 25 (1.1) | |
| Colitis | 1 | 6 (0.3) | |
| Enteritis | 2 (0.1) | 4 (0.2) | |
| Gastroduodenitis | 4 (0.1) | 2 (0.1) | |
| Colitis, ulcerative | 2 (0.1) | 2 (0.1) | |
| Duodenitis | 2 (0.1) | 2 (0.1) | |
| Gastrointestinal disorder | 3 (0.1) | 1 | |
| Gastrointestinal infection | 1 | 3 (0.1) | |
| Enteritis, infectious | 0 | 2 (0.1) | |
| Abdominal discomfort–associated TEAE | 127 (5.7) | 125 (5.6) | .95 |
| Abdominal pain | 61 (2.7) | 52 (2.3) | |
| Upper | 26 (1.2) | 24 (1.1) | |
| Lower | 2 (0.1) | 1 | |
| Location not reported by physician | 33 (1.4) | 27 (1.2) | |
| Dyspepsia | 34 (1.5) | 29 (1.3) | |
| Nausea | 30 (1.3) | 34 (1.5) | |
| Vomiting | 13 (0.6) | 13 (0.6) | |
| Flatulence | 6 (0.3) | 9 (0.4) | |
| Abdominal discomfort | 4 (0.2) | 4 (0.2) | |
| Irritable bowel syndrome | 2 (0.1) | 3 (0.1) | |
| Epigastric discomfort | 2 (0.1) | 2 (0.1) | |
| Gastrointestinal pain | 1 | 0 | |
| Fatigue | 25 (1.1) | 20 (0.9) | |
| Weight decrease | 17 (0.8) | 11 (0.5) | |
ROADMAP = Randomised Olmesartan and Diabetes Microalbuminuria Prevention; TEAE = treatment-emergent adverse event.