Patients with chronic kidney disease (CKD) and type-2 diabetes who took the experimental drug finerenone were about 30% less likely to develop atrial fibrillation (AFib) than those taking a placebo in the FIDELIO-DKD trial. The lower incidence of new-onset atrial fibrillation with finerenone was "generally consistent across prespecified subgroups," said lead investigator Dr. Gerasimos Filippatos of Attikon University Hospital in Athens in a presentation of the results at ACC.21, the virtual annual meeting of the American College of Cardiology. "Finerenone demonstrated cardiorenal protection in patients with CKD and diabetes irrespective of history of atrial fibrillation," he noted. The study was simultaneously published in the Journal of the American College of Cardiology. Finerenone is an experimental nonsteroidal, selective mineralocorticoid receptor antagonist. In FIDELIO-DKD, 5,674 patients with CKD and diabetes were randomly assigned to finerenone (10 or 20 mg once daily) or placebo on top of standard care and tracked for a median of 2.6 years. The primary endpoint was a composite of kidney failure, renal death or sustained decrease in estimated glomerular filtration rate (eGFR) of 40% or more from baseline. The key secondary outcome included cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for heart failure. As previously reported, finerenone significantly reduced the risk of kidney events by 18% and the risk of cardiovascular events by 14% compared with placebo. At ACC.21, Dr. Filippatos reported results of a prespecified analysis looking at the effect of finerenone on new-onset atrial fibrillation or flutter. The analysis showed that treatment with finerenone significantly reduced the incidence of new-onset Afib/flutter, which occurred in 82 patients on finerenone (3.2%) versus 117 on placebo (4.5%), for a hazard ratio of 0.71 (95% confidence interval, 0.53 to 0.94). Dr. Filippatos said the effect of finerenone on new-onset Afib was not modified by age, sex, kidney characteristics at screening, baseline serum potassium levels, blood pressure, body weight, hemoglobin A1c level or use of glucose-lowering medications. The effect of finerenone on kidney and cardiovascular outcomes was consistent independent of atrial fibrillation history. Preventing or delaying the onset of atrial fibrillation in patients with CKD and diabetes is "particularly important since having atrial fibrillation can worsen chronic kidney disease and having diabetes can worsen atrial fibrillation symptoms. Finerenone has the potential to reduce the burden of atrial fibrillation in these patients," Dr. Filippatos said in a news release. Commenting on the study at ACC.21, Dr. Anne Curtis of the University of Buffalo, in New York, noted that the study was done on a background of patients taking angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers "so finerenone is additive to that." "Basic studies suggested that there would be a reduction in atrial fibrillation, which is what led to this prespecified secondary analysis, so it's good to know that the reduction in atrial fibrillation happened," said Dr. Curtis. "I wouldn't treat patients right now specifically with this drug because it would reduce atrial fibrillation per se, but that could be an added benefit in certain selected patients," Dr. Curtis added. The study was funded by Bayer AG. Several authors have disclosed financial relationships with the company. —Megan Brooks Source
