Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis.
Academic Article
Overview
abstract
AIMS: Finerenone reduces the risk of cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). We investigated the causes of mortality in the FIDELITY population. METHODS AND RESULTS: The FIDELITY prespecified pooled data analysis from FIDELIO-DKD and FIGARO-DKD excluded patients with heart failure and reduced ejection fraction. Outcomes included intention-to-treat and prespecified on-treatment analyses of the risk of all-cause and cardiovascular mortality. Of 13 026 patients (mean age, 64.8 years; mean estimated glomerular filtration rate [eGFR], 57.6 mL/min/1.73 m2), 99.8% were on renin-angiotensin system inhibitors. Finerenone reduced the incidence of all-cause and cardiovascular mortality vs. placebo (8.5% vs. 9.4% and 4.9% vs. 5.6%, respectively) and demonstrated significant on-treatment reductions (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.70-0.96; P = 0.014 and HR, 0.82; 95% CI, 0.67-0.99; P = 0.040, respectively). Cardiovascular-related mortality was most common, and finerenone lowered the incidence of sudden cardiac death vs. placebo (1.3% [incidence rate 0.44/100 patient-years] vs. 1.8% [0.58/100 patient-years], respectively; HR, 0.75; 95% CI, 0.57-0.996; P = 0.046). The effects of finerenone on mortality were similar across all Kidney Disease: Improving Global Outcomes risk groups. Event probability with finerenone at 4 years was consistent irrespective of baseline urine albumin-to-creatinine ratio, but seemingly more pronounced in patients with higher baseline eGFR. CONCLUSION: In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population.
