In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone reduced new-onset atrial fibrillation or flutter (AFF) risk, according to findings published in the Journal of the American College of Cardiology. The risk for cardiovascular or kidney events was also reduced, regardless of AFF history at baseline.
Patients with CKD and T2D are at risk for AFF due to cardiac remodeling and kidney complications. Because the novel selective nonsteroidal mineralocorticoid receptor antagonist finerenone inhibits cardiac remodeling in preclinical models, investigators sought to examine the medication’s effect on new-onset AFF, as well as its cardiorenal effects, by history of AFF, by analyzing data from the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) phase 3 trial.
Participants were eligible if they were adults with CKD and T2D, had a urine ratio of albumin-to-creatinine ≥30 to ≤5000 mg/g, had an estimated glomerular filtration rate (eGFR) ≥25 to <75 ml/min/1.73 m2, and if they received optimized doses of renin-angiotensin system blockade. Participants were randomly assigned (1:1) to finerenone or placebo for a median follow-up of 2.6 years (interquartile range, 2.0-3.4 years) for all those in the full analysis set.
The effect of finerenone vs placebo on new-onset AFF was assessed as an adjudicated outcome by a committee of independent cardiologists. The primary kidney outcome (composite of time to kidney failure, a sustained ≥40% decrease in eGFR from baseline, or renal death) and key secondary cardiovascular outcome (composite of time to death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) were analyzed by history of AFF.
Out of all 5674 participants, 8.1% (n=461) had a history of AFF. New-onset adjudicated AFF occurred in 3.2% (82 of 2593) of participants on finerenone and 4.5% (117 of 2620) of those on placebo (hazard ratio [HR], 0.71; 95% CI, 0.53-0.94; P =.0164), for an incidence per 100 patient-years of 1.20 for finerenone and 1.72 for placebo.
The overall incidence of the primary kidney outcome was significantly lower with finerenone than with placebo (504 [17.8%] participants vs 600 [21.1%] participants, respectively; HR, 0.82; 95% CI, 0.73-0.93; P =.001).
Similarly, the overall incidence of the key secondary cardiovascular outcome was significantly lower with finerenone compared with placebo (367 [13.0%] participants vs 420 [14.8%] participants, respectively; HR, 0.86; 95% CI, 0.75-0.99; P =.034). The effect of finerenone on primary composite and key secondary outcomes was not significantly impacted by baseline AFF (P =.16 and P =.85, respectively).
Study investigators stated that findings should be interpreted with caution because this is a secondary analysis of a randomized controlled trial that had a modest number of new-onset AFF cases. They concluded, “Treatment with the selective, nonsteroidal mineralocorticoid receptor antagonist finerenone was associated with a lower incidence of newly detected atrial fibrillation in patients with [CKD] and [T2D]….finerenone reduced the risk [for] kidney or cardiovascular events, with no significant differences between patients with and without a history of AFF at baseline.”
Disclosure: This clinical trial was supported by Bayer AG. Please see the original reference for a full list of authors’ disclosures.
Filippatos G, Bakris GL, Pitt B, et al; FIDELIO-DKD Investigators. Finerenone reduces onset of atrial fibrillation in patients with chronic kidney disease and type 2 diabetes. J Am Coll Cardiol. Published online May 4, 2021. doi:10.1016/j.jacc.2021.04.079