PPI and H2RA use during phase 3 studies (mITT inpatients, n=701)
| PPI | H2RA | PPI/H2RA | |
|---|---|---|---|
| FDX (n=341) | |||
| Pretreatment | 152/303 (50.17%) | 17/39 (43.59%) | 168/339 (49.56%) |
| Day 1 of treatment | 173/344 (50.29%) | 20/48 (41.67%) | 191/388 (49.23%) |
| Treatment (days 1–10) | 198/380 (52.11%) | 23/55 (41.82%) | 215/423 (50.83%) |
| Follow-up (days 11–40) | 186/353 (52.69%) | 19/54 (35.19%) | 196/389 (50.39%) |
| At any time (days 1–40) | 212/404 (52.48%) | 31/71 (43.66%) | 227/446 (50.90%) |
| VAN (n=360) | |||
| Pretreatment | 151/303 (49.83%) | 22/39 (56.41%) | 171/339 (50.44%) |
| Day 1 of treatment | 171/344 (49.71%) | 28/48 (58.33%) | 197/388 (50.77%) |
| Treatment (days 1–10) | 182/380 (47.89%) | 32/55 (58.18%) | 208/423 (49.17%) |
| Follow-up (days 11–40) | 167/353 (47.31%) | 35/54 (64.81%) | 193/389 (49.61%) |
| At any time (days 1–40) | 192/404 (47.52%) | 40/71 (56.34%) | 219/446 (49.10%) |
| All (n=701) | |||
| Pretreatment | 303/701 (43.22%) | 39/701 (5.56%) | 339/701 (48.36%) |
| Day 1 of treatment | 344/701 (49.07%) | 48/701 (6.85%) | 388/701 (55.35%) |
| Treatment (days 1–10) | 380/701 (54.21%) | 55/701 (7.85%) | 423/701 (60.34%) |
| Follow-up (days 11–40) | 353/701 (50.36%) | 54/701 (7.70%) | 389/701 (55.49%) |
| At any time (days 1–40) | 404/701 (57.63%) | 71/701 (10.13%) | 446/701 (63.62%) |
Percentages in the FDX and VAN groups are based on the total number of patients with PPI, H2RA, or PPI/H2RA use among the 701 inpatients.
FDX, fidaxomicin; H2RA, histamine-2 receptor antagonist; mITT, modified intent to treat; PPI, proton pump inhibitor; VAN, vancomycin.