The aim of the trial was to examine the safety and efficacy of finerenone in decreasing cardiovascular events in patients with type 2 diabetes mellitus and chronic kidney disease. 

METHODS: In the study, eligible patients were randomized in a 1:1 manner to either finerenone (n=3686) or placebo (n=3666). Patients with an estimated glomerular filtration rate (eGFR0 of 25-60 ml/min/1.73 m² at the screening visit received an initial dose of 10 mg once daily, and those with an eGFR of ≥60 at the screening visit received an initial dose of 20 mg once daily. 

RESULTS: The primary composite outcome of CV death, myocardial infarction, stroke, hospitalization for heart failure, for finerenone vs. placebo, was 12.4% vs. 14.2% (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.76-0.98, p=0.03). The outcome of CV death was 5.3% vs. 5.8%, myocardial infarction 2.8% vs. 2.8%, stroke 2.9% vs 3.0%, and hospitalization for heart failure 3.2% vs. 4.4% (HR 0.71, 95% CI 0.56-0.90). 

CONCLUSIONS: The results of this trial indicate the finerenone has beneficial effects on CV outcomes among patients with T2DM and CKD, who were already being treated with maximal dose of RAS blockade therapy, primarily due to a reduction in hospitalization for HF. The pooled FIDELITY analysis corroborate the finding that finerenone is associated with CV benefits. 

Finerenone is a novel, non-steroidal, selective mineralocorticoid receptor antagonist with anti-inflammatory and antifibrotic effects. It is reported to have higher potency and less hyperkalemia than steroidal MRAs such as spironolactone and eplerenone. 

Reference: 

Pitt B, Filippatos G, Agarwal R, Anker SD, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. The New England Journal of Medicine. 2021. DOI: 10.1056/NEJMoa2110956

Kumbhani DJ. Finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease-FIGARI-DKD. August 28, 2021. Trial sponsor Bayer. Accessed on October 22, 2021,from https://www.acc.org/latest-in-cardiology/clinical-trials/2021/08/25/23/58/figaro-dkd