From: Report from the CVOT Summit 2020: new cardiovascular and renal outcomes
DAPA-CKD [29] | FIDELIO-DKD [32] | ||
---|---|---|---|
Class & cardiovascular/Kidney outcomes | HR (95.6% CI) p-value | Class & cardiovascular/Kidney outcomes | HR (95.6% CI) p-value |
Primary composite outcome Composite of sustained ≥ 50% eGFR decline, end-stage kidney disease, and renal or CV death | 0.61 (0.51–0.72) p = 0.0000000028 | Primary composite outcome Composite of onset of kidney failure, sustained ≥ 40% eGFR decline or renal death | 0.82 (0.73–0.93) p = 0.001 |
Secondary outcome Sustained ≥ 50% eGFR decline, ESKD or renal death | 0.56 (0.45–0.68) p = 0.0000000018 | Secondary outcome Composite of CV death, nonfatal MI, nonfatal stroke, and HHF | 0.86 (0.75–0.99) p = 0.03 |
Secondary outcome Chronic dialysis, kidney transplantation, renal death | 0.66 (0.49–0.90) p = 0.0072 | Secondary outcome All-cause mortality | 0.90 (0.75–1.07) |
Secondary outcome CV death or HHF | 0.71 (0.55–0.92) p = 0.0089 | Secondary outcome Hospitalisation for any cause | 0.95 (0.88–1.02) |
Secondary outcome All-cause mortality | 0.69 (0.53–0.88) p = 0.0035 |
Adverse events | Event rate (%) active vs. placebo group | Adverse events | Event rate (%) active vs. placebo group |
---|---|---|---|
Kidney event | 7.2 vs. 8.7 | Hypertension | 7.5 vs. 9.6 |
Diabetic ketoacidosis | 0.0 vs. 0.1 | Hyperkalaemia | 15.8 vs. 7.8 |
Volume depletion | 5.9 vs. 4.2 | Hypertension | 7.5 vs. 9.6 |