FIDELIO-DKD Analysis Finds Finerenone Reduces Risk of New-Onset AFib

An analysis of FIDELIO-DKD indicates use of finerenone was associated with significant reductions in risk of new-onset atrial fibrillation in patients with type 2 diabetes and chronic kidney disease.

New data from an analysis of FIDELIO-DKD suggests finerenone use was associated with a reduction in risk of atrial fibrillation (AF) among patients with chronic kidney disease (CKD) and type 2 diabetes.

Presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21), results of the analysis indicate use of the nonsteroidal, selective mineralocorticoid receptor antagonist was associated with a 29% reduction in risk of AF among patients in the trial.

“Preventing or delaying the onset of atrial fibrillation in patients with chronic kidney disease and diabetes is particularly important since having atrial fibrillation can worsen chronic kidney disease and having diabetes can worsen atrial fibrillation symptoms,” said lead investigator Gerasimos Filippatos, MD, of the National and Kapodistrian University of Athens, School of Medicine and Attikon University Hospital in Athens, Greece, in a statement. “Treatment in these patients can also be challenging because they are prone to developing blood clots and bleeding. Finerenone has the potential to reduce the burden of atrial fibrillation in these patients.”

After results of FIDELIO-DKD were presented at Kidney Week 2020 and suggested use of finerenone was associated with lowered risk of CKD progression and risk of the study’s cardiovascular outcome, finerenone was thrust into the spotlight as clinicians waited to learn more about the agent. The current analysis sought to provide further insight into the effect on new-onset AF as well as the impact of AF history on primary outcomes from the trial.

Briefly, the original FIDELIO-DKD trial randomized more than 5500 patients in a 1:1 ratio to either finerenone or placebo. For inclusion in the trial, patients needed to have a UACR of 30-5000 mg/g, an eGFR of 25-75 mL/min/1.73m2, and be receiving optimal medical therapy with RAAS inhibitors. The trial concluded finerenone use was associated with an 18% reduction in risk for progression of CKD and a 16% reduction in the composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.

The ACC.21 analysis included 5674 patients, including 461 (8.1%) with a history of AF or flutter (AFF). Investigators pointed out patients with a history of AF or flutter are more likely to be male, older, White, and use diuretics and beta-blockers at baseline than those with no history of AFF.

Results of the analysis indicated new-onset AFF occurred among 3.2% of patients on finerenone and 4.5% of patients receiving placebo, which correlates to an incidence rate per 100 patient-years of 1.20 and 1.72, respectively. (HR, 0.71; 95% CI, 0.53-0.94; P=.0164). Further analysis indicated this risk of new-onset AFF was not modified by age, sex, kidney function, blood pressure, BMI, HbA1c, or use of glucose-lowering therapies.

Additionally, analyses assessing the effect of finerenone on the primary and secondary outcomes from FIDELIO-DKD based on history of AFF at baseline suggested the benefits of finerenone were consistent regardless of baseline history.

“The previously-reported kidney and heart protection with finerenone applied equally to patients with and without pre-existing atrial fibrillation,” Filippatos said.

This study, “Finerenone Reduces Onset of Atrial Fibrillation in Patients with Chronic Kidney Disease and Type 2 Diabetes,” was presented at ACC.21 and simultaneously published in the Journal of the American College of Cardiology.