FIDELIO-DKD: Reduced Risk of New-Onset AFib With Finerenone in Patients With CKD and T2D

The novel drug finerenone was associated with a reduction in new-onset atrial fibrillation (AFib) in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), according to results from a prespecified analysis from the FIDELIO-DKD trial presented May 17 during ACC.21 and simultaneously published in the Journal of the American College of Cardiology.

The nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone (10 mg or 20 mg daily) vs. placebo was shown to reduce cardiovascular outcomes in 5,674 patients (average age 66; 70.2% male; about 70% white) with CKD and T2D over the median 2.6 years follow-up in the previously reported primary analysis of the international FIDELIO-DKD trial.

In this exploratory analysis, Gerasimos Filippatos, MD, et al., evaluated the impact of finerenone on the prespecified outcome of development of new-onset AFib and atrial flutter. The results showed that 3.2% (n=82) and 4.5% (n=117) of the finerenone and placebo groups, respectively, had new-onset AFib or flutter (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; p=0.016). The incidence per 100 patient-years was 1.20 with finerenone vs. 1.72 with placebo. The results were similar across prespecified patient subgroups. Most events were AFib; only 0.6% were atrial flutter.

The reduced risk of new-onset AFib was seen at six months and was sustained throughout the trial. Of note, for the primary and key secondary outcomes, the effect of finerenone was similar in the patients who did (8.1%) and did not have AFib at baseline. 

The investigators note this is a secondary analysis of a randomized controlled trial with a low number of events of new-onset AFib and as such should be interpreted with caution. They write, "Future research should assess the long-term clinical outcomes of treatment with finerenone in patients with CKD and T2D, including its impact on stroke and other cardiovascular events and survival."

In a related editorial comment, Gerald V. Naccarelli, MD, FACC, et al., state the findings should be considered hypothesis generating. "Until we have more information, upstream therapies, including MRAs, should be used in appropriate patient populations based on defined benefits with the hope that they will also reduce the development of [AFib/atrial flutter] over time."

Clinical Topics: Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ACC Annual Scientific Session, ACC21, Metabolic Syndrome, Arrhythmias, Cardiac, Diabetes Mellitus, Type 2, Atrial Fibrillation

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