Finerenone Mitigates HF, CV Risk Across Baseline Renal Function in Patients with T2D

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Finerenone, the first-in-class selective, nonsteroidal mineralocorticoid receptor antagonist, significantly improved heart failure (HF) outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) across categories of baseline kidney function.

The findings published online October 12 in JACC: Heart Failure, come from a pooled analysis of data from the landmark FIDELITY clinical trial program.

Finerenone was approved in July 2021 to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure (HHF) in individuals with CKD and T2D based on findings from the FIDELIO-DKD study. Most recently, the US Food and Drug Administration granted finerenone a label expansion to reflect positive cardiovascular (CV) outcomes from the FIGARO-DKD trial.

The current prespecified pooled analysis of patients from the phase 3 FIDELIO-DKD and FIGARO-DKD trials allowed investigators to assess the effects of finerenone on HF outcomes across a wider spectrum of CKD severity than could be appreciated in either trial alone. The study objective was to explore outcomes with the finerenone by baseline values of eGFR and urine albumin-to-creatinine ratio (UACR) in patients with CKD and T2D.

For their pooled analysis, the researchers had access to data related to 13 026 FIDELITY program participants who had been randomized to finerenone or placebo. They analyzed time-to-event outcomes—first HHF, CV death or first HHF, recurrent HHF, and CV death or recurrent HHF—in subgroups defined by baseline eGFR (<60 and ≥60 mL/min/1.73m²) and UACR (<300 and ≥300 mg/g).

Their analysis found that use of finerenone was associated with a significantly reduced risk of first HHF (HR, 0.78 [95% CI, 0.66-0.92]; P=.003), CV 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 CV death or recurrent HHF (HR, 0.82 [95% CI, 0.72-0.95]; P=.006) compared to placebo. Risk reductions were observed observed across baseline eGFR and UACR categories (P>.010). They found further that the lowest incidence of outcomes of interest was observed for those with an eGFR of ≥60 mL/min/1.73m² and a UACR <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,” the investigators concluded.

Reference: Filippatos G, Ankder SD, Pitt B, et al. Finerenone and heart failure outcomes by kidney function/albuminuria in chronic kidney disease and diabetes. J Am Coll Cardiol HF. Published online Oct 12, 2022. doi: 10.1016/j.jchf.2022.07.013