Analysis from the FIDELITY study examined finerenone use and kidney outcomes in patients with chronic kidney disease and type 2 diabetes.

In FIDELITY, a pre-specified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies, finerenone was found to improve cardiorenal outcomes in patients with type 2 diabetes, a urine albumin-to creatinine ratio of 30-5000 mg/g, an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m or more and also receiving optimized renin-angiotensin system blockade treatment. This present analysis focused on the efficacy and safety of finerenone on kidney outcomes. Among 13,026 patients with a median follow-up of three years, finerenone significantly reduced the hazard of a kidney composite outcome (time to kidney failure, sustained 57% or more decrease in eGFR from baseline, or kidney death) by 23% versus placebo (hazard ratio 0.77; 95% confidence interval 0.67-0.88), with a three-year absolute between group difference of (1.7%; 0.7-2.6). Hazard ratios were directionally consistent for a pre-specified baseline eGFR and urine albumin to creatinine ratio categories (P-interaction 0.62 and P-interaction 0.67, respectively), although there was a high degree of uncertainty in the 30-300 mg/g subgroup. Finerenone significantly reduced the hazard of kidney failure by 20% versus placebo (0.80; 0.64-0.99). Adverse events were similar between treatment arms although hyperkalemia, leading to treatment discontinuation, occurred significantly more frequently with finerenone versus placebo (2.4% vs 0.8% and 0.6% vs 0.3% in patients with eGFR under vs 60 ml/min/1.73 m and over, respectively). Thus, finerenone improved kidney outcomes, reduced the hazard of kidney failure, and is well tolerated in patients with chronic kidney disease and type 2 diabetes.