Table 10.
Frequency and incidence rate of user-defined renal impairment events
| Placebo (n = 4904) | EMPA 10 mg (n = 4858) | EMPA 25 mg (n = 5057) | EMPA 10/25 mg (n = 10,177) | |||||
|---|---|---|---|---|---|---|---|---|
| n (%) | Rate/100 pt-yrs | n (%) | Rate/100 pt-yrs | n (%) | Rate/100 pt-yrs | n (%) | Rate/100 pt-yrs | |
| Renal impairment | 169 (3.4) | 2.18 | 139 (2.9) | 1.75 | 152 (3.0) | 1.86 | 291 (2.9) | 1.78 |
| Acute kidney injurya | 44 (0.9) | 0.56 | 29 (0.6) | 0.36 | 28 (0.6) | 0.34 | 57 (0.6) | 0.34 |
| Renal impairment by baseline eGFR (CKD-EPI), ml/min/1.73 m2, n (%) | ||||||||
| ≥ 90 | 15/1933 (0.8) | 0.57 | 12/1998 (0.6) | 0.43 | 10/2041 (0.5) | 0.35 | 22/4177 (0.5) | 0.39 |
| 60 to < 90 | 63/2123 (3.0) | 1.73 | 57/2203 (2.6) | 1.48 | 60/2155 (2.8) | 1.56 | 117/4477 (2.6) | 1.50 |
| 45 to < 60 | 48/519 (9.2) | 4.92 | 46/464 (9.9) | 4.80 | 40/535 (7.5) | 4.09 | 86/1003 (8.6) | 4.44 |
| 30 to < 45 | 37/277 (13.4) | 7.85 | 21/182 (11.5) | 5.83 | 36/262 (13.7) | 8.38 | 57/445 (12.8) | 7.22 |
| < 30 | 6/52 (11.5) | 13.87 | 3/10 (30.0) | 20.63 | 6/61 (9.8) | 8.77 | 9/71 (12.7) | 10.85 |
CKD-EPI Chronic Kidney Disease Epidemiology Collaboration, eGFR estimated glomerular filtration rate, EMPA empagliflozin, MedDRA Medical Dictionary for Regulatory Activities, pt-yrs patient-years
aBased on the MedDRA preferred term