Table 2:
eGFR slopes and kidney outcomes in EMPEROR-Reduced and EMPEROR-Preserved. Three outcomes are presented; eGFR slopes and two different definitions of events, that differ in the % of eGGR reduction (40% vs 50%).
| EMPEROR-Reduced [36] | EMPEROR-Preserved [23] | |
|---|---|---|
| Follow-up 16 months | Follow-up 26 months | |
| eGFR slope from baseline to 30 days post trial, off treatment (mL/min/1.73 m2/year and 95% CI) [22] | ||
| Placebo | –0.27 (–2.97 to –1.58) (n = 468) | –2.39 (–2.63 to –2.16) (n = 1608) |
| Empagliflozin | –0.50 (–1.19 to 0.19) (n = 467) | –1.46 (–1.70 to –1.22) (n = 1568) |
| Difference of empagliflozin versus placebo | 1.77 (0.80 to 2.74) | 0.94 (0.60 to 1.27) |
| Kidney events [22] | Sustained decrease in eGFR by ≥40% only | Sustained decrease in eGFR by ≥40% only |
| Sustained decrease in GFR to <10–15 mL/min/1.73 m2, dialysis | Sustained decrease in GFR to <10–15 mL/min/1.73 m2, dialysis | |
| Or renal transplantation | Or renal transplantation | |
| Placebo, n (%)/events/100 patient-years | 58/1867 (3.1)/3.1 | 112/2991 (3.7)/2.2 |
| Empagliflozin, n (%)/events/100 patient-years | 30/1863 (1.6)/1.6 | 108/2997 (3.6)/2.1 |
| Empagliflozin versus placebo, HR (95% CI) | 0.51 (0.33–0.79) | 0.95 (0.73–1.24) |
| Kidney events [11] | Sustained decrease in eGFR by ≥50% only | Sustained decrease in eGFR by ≥50% only |
| Sustained decrease in GFR to < 10–15 mL/min/1.73 m2, dialysis | Sustained decrease in GFR to <10–15 mL/min/1.73 m2, dialysis | |
| Or renal transplantation | Or renal transplantation | |
| Placebo, n (%)/events/100 patient-years | DM 23/929 (2.5%)/2.4 | DM 44/1472 (3.0%)/1.8 |
| Non-DM 10/938 (1.1%)/1.0 | Non-DM 18/1519 (1.2%)/0.7 | |
| Empagliflozin, n (%)/events/100 patient-years | DM 13/927 (1.4%)/1.3 | DM 38/1466 (2.6%)/1.5 |
| Non-DM 5/936 (0.5%)/0.5 | Non-DM 12/1531 (0.8%)/0.45 | |
| Empagliflozin versus placebo, HR (95% CI) | DM 0.52 (0.26, 1.03) | DM 0.82 (0.53, 1.27) |
| Non-DM 0.50 (0.17, 1.48) | Non-DM 0.68 (0.33, 1.40) |
Despite reports highlighting a discrepancy between eGFR slopes and kidney events results [22], the discrepancy depends on the specific definition of kidney events and disappears when a stricter definition is used. In any case, these trials were not designed or powered to assess kidney events during a short follow-up of a population at relatively low risk of CKD progression based on low median UACR values.