Finerenone reduced cardiovascular and kidney events across CKM stages and increased CKM syndrome regression (11.4% vs 7.4%; aOR 1.66; 95% CI 1.30-2.13; P<.001) compared with placebo.
RCT (n=12,990)
double-blind
randomly assigned
Sí
Does finerenone reduce cardiovascular and kidney events and improve CKM syndrome regression in patients with type 2 diabetes and chronic kidney disease across CKM stages?
Finerenone reduces cardiovascular and kidney events and promotes CKM syndrome regression across all stages of cardiovascular-kidney-metabolic syndrome in patients with type 2 diabetes and chronic kidney disease.
Importance: Cardiovascular-kidney-metabolic (CKM) syndrome reflects the interplay of obesity, diabetes, chronic kidney disease (CKD), and cardiovascular disease. Finerenone is a nonsteroidal mineralocorticoid receptor antagonist that has improved outcomes in type 2 diabetes (T2D) and CKD. Objective: To evaluate the efficacy and safety of finerenone across CKM stages, and to examine the effects of finerenone on CKM syndrome progression and regression over time. Design, Setting, and Participants: This study is a post hoc pooled analysis of 2 randomized, double-blind, placebo-controlled, phase 3 multinational, multicenter clinical trials (FIDELITY) and was conducted across 48 countries. Patients with T2D and CKD with estimated glomerular filtration rate (eGFR) 25 mL/min/1.73 m2 or higher, serum potassium 4.8 mmol/L or less, and taking maximally tolerated renin angiotensin system inhibitor therapy were included and classified into CKM syndrome stages, using American Heart Association criteria. These data were analyzed from September 2025 and March 2026. Intervention: Participants in the pooled trials were randomly assigned to either finerenone or placebo. Main Outcomes and Measures: Cardiovascular composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospitalization and a kidney composite outcome of kidney failure, a sustained 57% or more decrease in eGFR from baseline over 4 weeks or more, or death from kidney failure. Results: Among 12 990 participants (mean SD age, 64.8 9.5 years; 3932 women 30% and 9058 men 70%) in FIDELITY, 3864 were classified as CKM stage 2 (30%), 3275 stage 3 (25%), and 5851 stage 4 (45%). After a median follow-up of 3 years, stage 4 was associated with a higher incidence of cardiovascular events (adjusted hazard ratio aHR, 1.87; 95% CI, 1.56-2.24) and kidney events (aHR, 1.96; 95% CI, 1.43-2.69) when compared with stage 2. Finerenone consistently reduced cardiovascular (P for interaction = .86) and kidney (P for interaction = .65) events, irrespective of baseline CKM stage. Absolute rate reductions for the composite cardiovascular outcome were -1.1 per 100 person-years for stage 4 and -0.4 per 100 person-years for stage 2. After 3 years, participants randomized to finerenone were more likely to experience CKM syndrome regression (11.4% vs 7.4%; adjusted odds ratio aOR, 1.66; 95% CI, 1.30-2.13; P < .001) and less likely to experience CKM syndrome progression (aOR, 0.89; 95% CI, 0.79, 1.00; P = .05) vs placebo. Conclusions and Relevance: Among patients with T2D and CKD in this study, finerenone reduced risks of cardiovascular and kidney events across CKM stages and led to greater CKM syndrome regression, and lesser CKM syndrome progression, over time. Trial Registration: ClinicalTrials.gov Identifier: NCT02540993 and NCT02545049.
“Importantly, participants who experience new-onset AFib/AFL were at a substantially higher subsequent risk of adverse cardiovascular and kidney outcomes than were those who remained free of AFib/AFL during follow-up. These findings highlight the role of finerenone in reducing the risk of new-onset AFib/AFL, mitigating downstream complications, and ultimately improving outcomes in patients across the CKM spectrum.”
Just published June 3, 2026; immediate coverage in cardiology media and JACC discussions.
Lo et al. (Wed,) conducted a rct in Type 2 diabetes and chronic kidney disease (CKM syndrome) (n=12,990). Finerenone vs. Placebo was evaluated on Cardiovascular composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospitalization and a kidney composite outcome of kidney failure, a sustained 57% or more decrease in eGFR from baseline over 4 weeks or more, or death from kidney failure. Finerenone reduced cardiovascular and kidney events across CKM stages and increased CKM syndrome regression (11.4% vs 7.4%; aOR 1.66; 95% CI 1.30-2.13; P<.001) compared with placebo.