Table 2.
Incidence, severity, and etiology of AKI events
| Description | All Patients, n=1448 | Monotherapy, n=724 | Combination Therapy, n=724 | P Value |
|---|---|---|---|---|
| Person-months of treatment exposure | 37,443 | 18,678 | 18,765 | |
| Individuals with AKI | 210 (8.6) | 80 (11.0) | 130 (18.0) | <0.001 |
| AKI events | 295 | 105 | 190 | |
| No. of episodes (%) of AKI per individual | 0.30 | |||
| 1a | 159 (75.7) | 63 (78.8) | 96 (73.8) | |
| 2a | 31 (14.8) | 12 (15.0) | 19 (14.6) | |
| >2a | 20 (9.5) | 5 (6.2) | 15 (11.5) | |
| AKI events per 100 person-yr (95% confidence interval) | 9.5 (8.4 to 10.6) | 6.7 (5.6 to 8.2) | 12.2 (10.5 to 14.0) | <0.001 |
| Severity of AKI | 0.71 | |||
| No. of events (%) with evaluable data | 287 (97.3) | 103 (98.1) | 184 (96.8) | |
| >50%–100% increase in serum creatinineb | 109 (38.0) | 35 (34.0) | 74 (40.2) | |
| >100%–200% increase in serum creatinineb | 89 (31.0) | 37 (35.9) | 52 (28.3) | |
| >200% increase in serum creatinineb | 36 (12.5) | 10 (9.7) | 26 (14.1) | |
| AKI events requiring RRTa (%) | 29 (10.1) | 12 (11.5) | 17 (9.1) | 0.49 |
| Community- versus hospital-acquired AKI (%) | 0.79 | |||
| No. of events with evaluable data | 289 (98.0) | 104 (99.0) | 185 (97.4) | |
| Community acquiredb | 189 (65.4) | 67 (64.4) | 122 (65.9) | |
| Hospital acquiredb | 100 (34.6) | 37 (35.6) | 63 (34.1) | |
| Etiology of episodes of AKIc (%) | ||||
| No. of events with evaluable data | 290 (98.3) | 104 (99.0) | 186 (97.9) | |
| Prerenalb | 218 (75.2) | 76 (73.1) | 142 (76.3) | 0.54 |
| Acute tubular necrosisb | 71 (24.5) | 25 (24.0) | 46 (24.7) | 0.90 |
| Acute interstitial nephritisb | 13 (4.5) | 7 (6.8) | 6 (3.2) | 0.17 |
| Obstructive uropathyb | 18 (6.2) | 8 (7.7) | 10 (5.4) | 0.43 |
| Otherb | 19 (6.6) | 8 (7.7) | 11 (5.9) | 0.56 |
a
Percentages calculated on the basis of total number of AKI events.
b
Percentages calculated on the basis of number of AKI events with evaluable data.
c
Totals exceed 100%, because some patients were classified as having multifactorial AKI.