Abstract 4369294: Estimated Lifetime Benefits of Finerenone on Cardiorenal Morbidity and Mortality in Patients with Type 2 Diabetes and Chronic Kidney Disease

Abstract

Introduction: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, improves cardiovascular and kidney outcomes in people with type 2 diabetes and chronic kidney disease (CKD). However, the long-term impact of finerenone on delaying or preventing cardiorenal events is not known. Purpose: To estimate the lifetime benefits of finerenone vs. placebo on cardiorenal morbidity and mortality in persons with type 2 diabetes and CKD. Methods: In this participant-level pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials (FIDELITY), we estimated the effects of finerenone on long-term survival free from cardiorenal morbidity and mortality using validated, nonparametric, and age-based actuarial methods. The main outcome was a cardiorenal composite outcome comprised of all-cause death and the individual components of the prespecified cardiovascular (heart failure hospitalization, non-fatal myocardial infarction, or non-fatal stroke) and kidney (CKD progression [sustained ≥57% decrease in eGFR] or kidney failure) composite endpoints. Results: Among 12,990 pooled trial participants, the risk of cardiorenal morbidity or mortality was lower with finerenone (71.8 events per 1000 person-years) vs. placebo (85.4 events per 1000 patient years; HR, 0.84 [95% CI, 0.78 to 0.90]) over a median trial follow-up of 3.0 [2.3, 3.8] years. In actuarial analyses examining lifetime trajectories for a 65-year-old trial participant, mean survival free from cardiorenal morbidity or mortality was 10.2 years (95% CI, 9.7 to 10.7) with placebo and 11.5 years (95% CI, 11.0 to 12.0) with finerenone, representing an additional 1.3 years (95% CI, 0.6 to 2.0 years) of event-free survival ( Figure, Panel A ). Cardiorenal event-free survival gains were observed across a broad age range, from 1.2 years (95% CI, 0.2 to 2.3 years) at age 55 to 0.8 years (95% CI, 0.1 to 1.4 years) at age 75 ( Figure, Panel B ). Conclusions: Treatment with finerenone is projected to afford clinically relevant long-term gains in survival free from cardiorenal morbidity and mortality, reinforcing its role as a key component of guideline-directed medical therapy for persons with type 2 diabetes and CKD.