Patients with chronic kidney disease and type 2 diabetes who took the experimental drug finerenone developed about a 30% less chance of developing atrial fibrillation (AFib) than those who took placebo, according to the American College of Cardiology’s 70th year income Scientific session.
Last year, researchers reported that the study, named FIDELIO-DKD, met its primary endpoint and showed significant benefit from finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, in terms of a combination of persistent decline in kidney function, kidney failure, and kidney death. The new analysis shows that patients received these benefits regardless of their history of AFib, and suggests that taking finerenone also decreased the rate of new AFib onset.
“Finerenone can lower the risk of developing atrial fibrillation in patients with chronic kidney disease and diabetes and can be used as a therapeutic strategy to delay the onset,” said Dr. Gerasimos Filippatos from the National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital in Athens, Greece, and the lead author of the study. “It can also protect the heart and kidney from further damage caused by chronic kidney disease and diabetes in these patients with or without pre-existing atrial fibrillation.”
Chronic kidney disease, diabetes and AFib are major public health concerns around the world. Patients with chronic kidney disease and diabetes are at increased risk of developing AFib, as these conditions can lead to changes in heart structure and electrical signal transmission, leading to rapid and irregular heart rhythms. In preclinical studies, finerenone has been reported to slow these structural changes.
FIDELIO-DKD randomly assigned 5,674 patients with chronic kidney disease and diabetes to take finerenone or a placebo and tracked the results for a median of 2.6 years. The primary endpoint was a combination of kidney failure, kidney death, or a persistent decrease in the estimated glomerular filtration rate (a measure of kidney function) of 40% or more from baseline. The main secondary outcome was death from loss of heart function, a non-fatal myocardial infarction, a non-fatal 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 to placebo. For the new analysis, researchers assessed the results in patients with and without a history of AFib or atrial flutter (approximately 8% of participants had AFib or atrial flutter at baseline) and the risk that patients would develop AFib or atrial flutter during the study.
The results showed that the primary and secondary endpoints in patients taking finerenone were significantly lower regardless of their AFib status at the start of the study.
“The previously reported kidney and heart protection with finerenone was used equally in patients with and without pre-existing atrial fibrillation,” said Filippatos.
In addition, new onset AFib or atrial flutter was reported in 3.2% of patients taking finerenone and 4.5% of patients taking placebo, a significant difference in favor of finerenone.
Researchers said that previous results from preclinical studies indicated that finerenone may help reduce scarring and thickening of heart tissue, possibly through its effect of blocking mineralocorticoid receptors, a type of protein molecule found on many cell types in the heart and kidney shown to be particularly common in patients with AFib.
“Preventing or delaying the onset of atrial fibrillation in patients with chronic kidney disease and diabetes is especially important because atrial fibrillation can worsen chronic kidney disease and diabetes can worsen atrial fibrillation symptoms,” Filippatos said. “Treating these patients can also be challenging because they are prone to developing blood clots [which can lead to stroke] and bleeding. Finerenone has the potential to reduce the burden of atrial fibrillation in these patients. “
Filippatos said larger studies specifically focusing on emerging AFib would be needed to confirm the results. Since participants at FIDELIO-DKD were only given cardiac rhythm tests once a year, Filippatos says it is possible that researchers have missed asymptomatic AFib or cases that were not evident from tests. A separate study is currently ongoing to examine the effects of finerenone in patients with less severe chronic kidney disease and diabetes.
This study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation. The study was funded by Bayer AG. Filippatos will be available to the media in a virtual press conference on Monday, May 17 at 12:15 p.m. ET / 4:15 p.m. UTC.
Filippatos will virtually present the study “Finerenone and New Onset of Atrial Fibrillation or Flutter in Patients with Chronic Kidney Disease and Type 2 Diabetes” on Monday, May 17 at 10:45 am ET / 2:45 pm UTC.
ACC.21 will take place virtually from May 15-17, bringing together cardiologists and cardiovascular specialists from around the world to share the latest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter, and # ACC21 for the latest news from the meeting.
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As a professional home for the entire cardiovascular care team, the mission of the college and its 54,000 members is to transform cardiovascular care and improve heart health. The ACC awards credentials to cardiovascular professionals who meet rigorous qualifications and are leaders in setting health policies, standards and guidelines. The college also provides professional medical training, disseminates cardiovascular research through its world-renowned JACC journals, operates national registers to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. More information is available at ACC.org.
Disclaimer: AAAS and EurekAlert! are not responsible for the correctness of the press releases published on EurekAlert! by contributing institutions or for the use of information via the EurekAlert system.