Finerenone Reduces Negative CV Outcomes in Type 2 Diabetes, Irrespective of Baseline Kidney Function

Using data from the landmark FIDELITY program, new research is providing clinicians and researchers with further insight into the effects of finerenone in people with diabetes according to baseline kidney function.

An analysis assessing associations of finerenone use and heart failure outcomes in people with chronic kidney disease (CKD) and diabetes, results of the analysis, which assessed effects according to eGFR and/or urine albumin-to-creatinine ratio (UACR), suggest finerenone improved heart failures outcomes irrespective of baseline eGFR or UACR categories among people from the FIDELIO-DKD and FIGARO-DKD trials.

“This posthoc pooled analysis of the phase 3 FIDELIO-DKD and FIGARO-DKD trials showed that finerenone reduced the risk of HF-related outcomes in patients with T2D across a broad spectrum of CKD,” wrote investigators. “The treatment benefits of finerenone were not modified by baseline eGFR and UACR categories; however, the magnitude of the treatment benefit tended to favor patients with less advanced CKD.”

Despite advances in pharmacotherapy and management of CKD, the ballooning prevalence of diabetes threatens to turn this ongoing public health crisis into a future epidemic. As a result, optimization of prescription and access to newer agents with cardiorenal protective benefits has become a focal point of many research and implementation efforts. A first-in-class agent receiving approval to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in individuals with CKD and type 2 diabetes, finerenone stands poised to have a substantial impact on the growing public health crises. More recently, finerenone received a label expansion from the US FDA to reflect cardiovascular outcomes from FIGARO-DKD.

With this in mind, the current study was designed by FIDELITY investigators with the intent of providing clinicians with new insight into the benefits of finerenone use on heart failure outcomes according to baseline kidney function among people with diabetes and CKD. From FIDELITY, investigators obtained data related to 13,026 people with diabetes and chronic kidney disease for inclusion in their analysis.

For the purpose of analysis, eGFR categories were defined as less than 60 mL/min/1.73m2 or 60 mL/min/1.73m2 and more while UACR categories were defined as less than 300 mg/g or 300 mg/g and more. The primary time-to-event outcomes of interest were first hospitalization for heart failure (HHF), cardiovascular death or first HHF, recurrent HHF, and cardiovascular death or recurrent HHF.

Upon analysis, results indicated use of finerenone was associated with a significantly reduce risk of first HHF (HR, 0.78 [95% CI, 0.66-0.92]; P=.003), cardiovascular death or first HHF (HR, 0.83 [95% CI, 0.74-0.93]; P=.002), recurrent HHF (HR, 0.79 [95% CI, 0.64-0.96]; P=.021), and cardiovascular death or recurrent HHF (HR, 0.82 [95% CI, 0.72-0.95]; P=.006) compared to placebo, with risk reductions observed across baseline eGFR and UACR categories (P >.010). Further analysis suggested the lowest incidence of outcomes of interest was observed for those with an eGFR of 60 mL/min/1.73m2 or greater and a UACR less than 300 mg/g.

“The FIDELITY-HF analysis demonstrates the consistent benefits of finerenone on HF-related outcomes across CKD stages in patients with T2D, regardless of eGFR or UACR at baseline. This reinforces the importance of routine eGFR and UACR screening in clinical practice to ensure early initiation of treatment with finerenone to address cardiovascular risk and morbidity associated with HHF,” wrote investigators in their conclusion.

This study, “Finerenone and Heart Failure Outcomes by Kidney Function/Albuminuria in Chronic Kidney Disease and Diabetes,” was published in JACC: Heart Failure.