Finerenone consistently reduced the composite cardiovascular outcome versus placebo in patients with type 2 diabetes and chronic kidney disease, irrespective of baseline ASCVD (P-interaction=0.38).
RCT (n=13,026)
Does finerenone reduce cardiovascular and kidney outcomes in patients with T2D and CKD, irrespective of baseline ASCVD?
Finerenone provides consistent cardiovascular and kidney benefits in patients with T2D and CKD, irrespective of baseline ASCVD status.
p-value: p=0.38 for interaction
AIMS: Finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, improves cardiovascular (CV) and kidney outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). This subgroup analysis of FIDELITY, a pre-specified, pooled, individual patient-data analysis of FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049), compared finerenone vs. placebo in patients with and without baseline history of atherosclerotic CV disease (ASCVD). METHODS AND RESULTS: Outcomes included a composite CV outcome CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF); CV death or HHF; a composite kidney outcome (kidney failure, sustained estimated glomerular filtration rate decrease ≥57%, or kidney-related death); all-cause mortality; and safety by baseline history of ASCVD.Of 13 026 patients, 5935 (45.6%) had a history of ASCVD. The incidence of the composite CV outcome, CV death or HHF, and all-cause mortality was higher in patients with ASCVD vs. those without, with no difference between groups in the composite kidney outcome. Finerenone consistently reduced outcomes vs. placebo in patients with and without ASCVD (P-interaction for the composite CV outcome, CV death or HHF, the composite kidney outcome, and all-cause mortality 0.38, 0.68, 0.33, and 0.38, respectively). Investigator-reported treatment-emergent adverse events were consistent between treatment arms across ASCVD subgroups. CONCLUSION: Finerenone reduced the risk of CV and kidney outcomes consistently across the spectrum of CKD in patients with T2D, irrespective of prevalent ASCVD.
Filippatos et al. (Mon,) conducted a rct in Type 2 diabetes and chronic kidney disease (n=13,026). Finerenone vs. Placebo was evaluated on Composite CV outcome [CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF)] (p=0.38 for interaction). Finerenone consistently reduced the composite cardiovascular outcome versus placebo in patients with type 2 diabetes and chronic kidney disease, irrespective of baseline ASCVD (P-interaction=0.38).