Log in to MyACC
Finerenone and CV Risk in Type 2 Diabetes With Chronic Kidney Disease
Quick Takes
- In a pooled analysis of data from the FIDELIO-DKD and FIGARO-DKD trials in patients with type 2 diabetes mellitus and albuminuric CKD, finerenone was associated with reduced cardiovascular risk (hazard ratio, 0.86; 95% CI, 0.78-0.95; p = 0.002).
- In a population-based simulation among subjects with T2DM and albuminuric CKD, finerenone was shown to prevent 38,359 cardiovascular events per 100 patient-years, including approximately 14,000 hospitalizations for heart failure. Approximately two thirds of these events occurred in patients with preserved eGFR.
Study Questions:
Does finerenone, a nonsteroidal mineralocorticoid receptor antagonist, modify cardiovascular (CV) risk in patients with type 2 diabetes mellitus (T2DM) and albuminuric chronic kidney disease (CKD)?
Methods:
FIDELITY was a pooled analysis of data from the phase 3 trials FIDELIO-DKD and FIGARO-DKD, both of which evaluated the effects of finerenone on CKD and CV outcomes in adults with T2DM. From this dataset, incidence rates of CV events (composite of CV death, nonfatal stroke, nonfatal myocardial infarction, and hospitalization for heart failure) were estimated by estimated glomerular filtration rate (eGFR) and albuminuria categories. Using data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018, a Monte Carlo simulation was performed to estimate the number of composite CV events that may be prevented with finerenone per year at a population level.
Results:
A total of 13,026 participants (mean age 64.8 years, 69.8% male) were included from FIDELITY. At baseline, >99% of participants were on renin-angiotensin system inhibitors, while <10% were on sodium-glucose cotransporter 2 inhibitors (SGLT2i). Incidence rates of CV events were higher in patients in lower eGFR and higher urine albumin-to-creatinine ratio (UACR) categories. As compared with placebo, finerenone was associated with reduced CV risk (hazard ratio, 0.86; 95% confidence interval [CI], 0.78-0.95; p = 0.002). This reduction in CV risk with finerenone occurred across the ranges of eGFR and UACR (p for interaction = 0.66). Based on the FIDELITY data, the total excess number of CV events that would be prevented with finerenone per 100 patient-years was 67 (95% CI, 24-111).
From NHANES, approximately 6.4 million individuals with T2DM and albuminuric CKD were identified. The majority of subjects (74.7%) had eGFR ≥60. The simulated number of CV events that would be prevented with finerenone per 100 patient-years was 38,359 (95% CI, 31,741-44,852), including approximately 14,000 hospitalizations for heart failure. Of the simulated CV events that could be prevented in this population, 66.1% were in patients with preserved eGFR (i.e., CKD diagnosed based on albuminuria alone).
Conclusions:
The authors conclude that finerenone can reduce CV event rates in patients with T2DM and albuminuric CKD. In a population-based simulation, most events were prevented in patients with preserved eGFR.
Perspective:
This study highlights the importance of identifying and addressing albuminuria in patients with T2DM. While annual UACR testing is standard of care in T2DM, urine testing is frequently overlooked in routine care. A potential adverse consequence of adding finerenone to renin-angiotensin system inhibitors is hyperkalemia, and particularly in patients with advanced CKD, close laboratory surveillance is important. Notably, few patients in FIDELITY were on SGLT2i, which are now standard of care for T2DM with CKD, as well as for heart failure with or without T2DM. CONFIDENCE (ClinicalTrials.gov Identifier: NCT05254002) is an ongoing phase 2 trial that is assessing the combination of finerenone and empagliflozin in T2DM with CKD.
Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure
Keywords: Acute Kidney Injury, Albumins, Albuminuria, Angiotensins, Creatinine, Diabetes Mellitus, Type 2, Glomerular Filtration Rate, Heart Failure, Metabolic Syndrome, Mineralocorticoid Receptor Antagonists, Myocardial Infarction, Myocardial Ischemia, Primary Prevention, Renal Insufficiency, Chronic, Risk Factors, Stroke, Sodium-Glucose Transporter 2 Inhibitors
< Back to Listings
