Baseline and disease characteristics (mITT inpatients, n=701)
| PPI/H2RA users | PPI/H2RA non-users | |||||
|---|---|---|---|---|---|---|
| FDX (n=241) n (%) | VAN (n=241) n (%) | All (n=482) n (%) | FDX (n=100) n (%) | VAN (n=119) n (%) | All (n=219) n (%) | |
| Age (years) | ||||||
| Mean±SD | 67.5 (14.98) | 68.6 (14.32) | 68.1 (14.65) | 67.6 (16.28) | 64.3 (18.30) | 65.8 (17.40) |
| ≤40 | 14 (5.8) | 10 (4.2) | 24 (5.0) | 8 (8.0) | 15 (12.6) | 23 (10.5) |
| 41–50 | 20 (8.3) | 17 (7.1) | 37 (7.7) | 7 (7.0) | 17 (14.3) | 24 (11.0) |
| 51–60 | 31 (12.9) | 39 (16.2) | 70 (14.5) | 16 (16.0) | 16 (13.5) | 32 (14.6) |
| 61–70 | 55 (22.8) | 52 (21.6) | 107 (22.2) | 24 (24.0) | 15 (12.6) | 39 (17.8) |
| 71–80 | 76 (31.5) | 63 (26.1) | 139 (28.8) | 17 (17.0) | 28 (23.5) | 45 (20.6) |
| ≥81 | 45 (18.7) | 60 (24.9) | 105 (21.8) | 28 (28.0) | 28 (23.5) | 56 (25.6) |
| Sex | ||||||
| Female | 126 (52.3) | 119 (49.4) | 245 (50.8) | 56 (56.0) | 67 (56.3) | 123 (56.2) |
| Male | 115 (47.7) | 122 (50.6) | 237 (49.2) | 44 (44.0) | 52 (43.7) | 96 (43.8) |
| Serum albumin (g/dL) | ||||||
| ≥2.5 | 145/224 (64.7) | 123/218 (56.4) | 268/442 (60.6) | 63/91 (69.2) | 81/110 (73.6) | 144/201 (71.6) |
| <2.5 | 79/224 (35.3) | 95/218 (43.6) | 174/442 (39.4) | 28/91 (30.8) | 29/110 (26.4) | 57/201 (28.4) |
| WCC | ||||||
| ≥15×109/L | 51/216 (23.6) | 36/209 (17.2) | 87/425 (20.5) | 22/86 (25.6) | 27/108 (25.0) | 49/194 (25.3) |
| <15×109/L | 165/216 (76.4) | 173/209 (82.8) | 338/425 (79.5) | 64/86 (74.4) | 81/108 (75.0) | 145/194 (74.7) |
| Serum creatinine (mg/dL) | ||||||
| ≥1.5 | 48/230 (20.9) | 56/225 (24.9) | 104/455 (22.9) | 17/94 (18.1) | 14/110 (12.7) | 31/204 (15.2) |
| <1.5 | 182/230 (79.1) | 169/225 (75.1) | 351/455 (77.1) | 77/94 (81.9) | 96/110 (87.3) | 173/204 (84.8) |
| Prior CDAD episode | ||||||
| Yes | 32 (13.3) | 40 (16.6) | 72 (14.9) | 20 (20.0) | 13 (10.9) | 33 (15.1) |
| No | 209 (86.7) | 201 (83.4) | 410 (85.1) | 80 (80.0) | 106 (89.1) | 186 (84.9) |
| Study drug exposure (days) | ||||||
| Mean ± SD | 8.9 (2.43) | 8.8 (2.98) | 8.9 (2.71) | 9.0 (2.56) | 9.2 (2.26) | 9.1 (2.40) |
Patients receiving PPIs or H2RAs in the pre-treatment, treatment, and follow-up periods are included in the ‘PPI/H2RA users’ category.
CDAD, Clostridium difficile-associated diarrhoea; FDX, fidaxomicin; H2RA, histamine-2 receptor antagonist; mITT, modified intent to treat; PPI, proton pump inhibitor; VAN, vancomycin; WCC, white cell count.