Introduction: In FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone reduced the risk of cardiovascular (CV) and kidney events versus placebo in patients with type 2 diabetes and chronic kidney disease, on optimized renin-angiotensin system blockade. This FIDELITY post hoc subanalysis explores the efficacy and safety of finerenone in Asian patients.
Methods: For this subanalysis, efficacy outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks or renal death) outcome. A change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4 and eGFR slopes was also assessed. All outcomes were assessed by baseline eGFR (<60 and ≥60 mL/min/1.73 m2) and UACR (<300 and ≥300 mg/g) subgroups. Safety outcomes were reported as treatment-emergent adverse events, including laboratory evaluations for hyperkalemia.
Results: In the Asian subpopulation, 1,412/2,858 (49.4%) received finerenone. Finerenone-treated Asian patients had a lower risk of the composite CV outcome (hazard ratio [HR] = 0.90; 95% confidence interval [CI], 0.70-1.15) and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR = 0.64; 95% CI, 0.50-0.82 and HR = 0.67; 95% CI, 0.56-0.80, respectively) versus those receiving placebo, irrespective of baseline eGFR and UACR. Data on change of eGFR from baseline over the course of the trials indicated that chronic kidney disease progression in Asian patients was slower with finerenone versus placebo. Overall, safety outcomes were balanced between both populations. Serum potassium values with finerenone were similar between the Asian and non-Asian subpopulations (>5.5 mmol/L: 15.6% versus 17.1%; >6.0 mmol/L: 4.6% versus 2.9%, respectively), while hyperkalemia leading to permanent treatment discontinuation with finerenone was low in both populations (Asian: 1.5%; non-Asian: 1.8%).
Conclusion: Finerenone reduced the risk of CV and kidney events and demonstrated a well-tolerated safety profile in the FIDELITY Asian subpopulation.
Keywords: Asian; Cardiovascular and kidney outcomes; Chronic kidney disease; Finerenone; Type 2 diabetes.
Type 2 diabetes, a condition in which there is too much glucose (a type of sugar) in the blood due to a problem with the hormone insulin, is a well-known cause of chronic kidney disease. People with chronic kidney disease and type 2 diabetes are also more likely to experience a heart event, such as a heart attack or stroke. Adults from Asia are more likely to have heart disease and more severe kidney disease compared with White adults. This study of two recent clinical trials, called the FIDELITY project, looked at how well the drug finerenone, a medicine used to treat the heart and kidneys in people with chronic kidney disease and type 2 diabetes, worked in about 3,000 participants from Asia. Finerenone was shown to slow down the rate of kidney function decline and reduce protein in the urine (a sign of kidney damage), as well as to lower the risk of having or dying from a heart event in Asian adults with chronic kidney disease and type 2 diabetes, as it does in non-Asian adults. A side effect of people taking drugs like finerenone is an increase in the levels of potassium in the blood, called hyperkalemia, which, in serious cases, can lead to changes in heart rate and rhythm. In this study, hyperkalemia was mostly nonserious and easy for doctors to identify and manage. Overall, this study showed that finerenone can benefit Asian adults with heart and kidney events caused by chronic kidney disease and type 2 diabetes.
© 2025 The Author(s). Published by S. Karger AG, Basel.