Finerenone treatment in patients with type 2 diabetes and diabetic kidney disease was associated with a significant drop in the incidence of new onset atrial fibrillation as a pre-specified exploratory endpoint of the FIDELIO-DKD fundamental trial that randomized more than 5,700 patients.
Finerenone treatment related to a relative reduction of 29% compared to placebo in incident cases of atrial fibrillation (AFib), Gerasimos Filippatos, MD, reported at the annual scientific sessions of the American College of Cardiology.
The absolute reduction was modest, with a reduction of 1.3%, from the 4.5% incidence rate in placebo to a 3.2% finerenone rate for an average of 2.6 years. tracking. Simultaneously with the report, the results appeared online (J Am Coll Cardiol. 2021 May 17. doi: 10.1016 / j.jacc.2021.04.079).
The analyzes presented by Filippatos also showed that whether or not patients had a history of AFib, there was no impact on the main benefit of finerenone treatment seen in FIDELIO-DKD, which resulted in a significant 18% reduction in relative risk compared with placebo in the combined rate of renal failure, a decrease of 40% or more from baseline in the estimated rate of glomerular filtration or renal death.
Similarly, the previous AFib status had no effect on the key secondary endpoint of the study, a significant 14% reduction in relative risk in the combined cardiovascular death rate, nonfatal, nonfatal IM stroke, or hospitalization for heart attack.
The main results of FIDELIO-DKD (Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and diabetic kidney disease) appeared in a 2020 report (N Engl J Med. December 3, 2020; 383; 2219-29).
“Side benefits can be very helpful”
“It is important to know the benefits of finerenone beyond the main outcome of a trial, as the side benefits can be very helpful,” he said. Anne B. Curtis, MD, electrophysiologist and professor and professor of medicine in the University of Buffalo, NY School of Medicine and Biomedical Sciences. “It’s not a big benefit, but that could be an added benefit for selected patients,” he said during a press conference. “Background studies had shown a favorable remodeling of the heart [by finerenone] this could affect AFib “.
The possible attenuating effects of finerenone on inflammation and fibrosis could also mediate the apparent effect of the drug on AFib, said Filippatos, a professor of cardiology and director of the University Hospital’s Heart Failure and Cardio-Oncology Clinic. Attikon and the University of Athens.
He noted that additional data on a possible AFib effect of finerenone will soon emerge FIGARO-DKD , which enrolled patients similar to those of FIDELIO-DKD but with more moderate stages of kidney disease, and FINEARTS-HF trial, which examines the effect of finerenone in patients with heart failure with an ejection fraction of at least 40%.
“Heart failure and AFib go closely together. It’s worth studying specifically, so we can see if there’s an impact of finerenone in patients with heart failure who don’t necessarily have kidney disease or diabetes,” he said. Curtis.
The new findings reported by Filippatos “should be considered generators of hypotheses. Until we have more information, previous therapies, including mineralocorticoid receptor antagonists [MRAs, the umbrella drug class that includes finerenone], should be used in appropriate patient populations based on defined benefits, in the hope that they will also reduce the development of AFib and atrial flutter over time, “Gerald V. Naccarelli, MD, and his co-authors wrote in an editorial accompanying the report (J Am Coll Cardiol. 2021 May 17. doi: 10.1016 / j.jacc.2021.04.080).
The FIDELIO-DKD trial randomized 5,734 patients in 913 sites in 48 countries, including 461 patients with a history of AFib. The observed link of finerenone treatment with a reduced incidence of AFib appeared to be consistent regardless of age, sex, race, baseline renal characteristics of patients, basal systolic blood pressure levels, potassium. serum, body mass index, A1c, or use of medications to lower glucose.
Finerenone belongs to a new class of ARMs that have a non-steroidal structure, in contrast to ARMs spironolactone i eplerenone. This means that finerenone does not produce steroid-associated adverse effects related to other ARMs, such as gynecomastia, and may also differ in other actions.
FIDELIO-DKD was sponsored by Bayer, the company that develops finerenone. Filippatos has received conference fees or participated in test management on behalf of Bayer, as well as for Amgen, Boehringer Ingelheim, Medtronic, Novartis, Servier and Vifor. Curtis is an advisor and receives fees St. Jude Medical and receives fees from Medtronic. Naccarelli has been a consultant to Accession, ARCA, GlaxoSmithKline, Janssen, Milestone, Omeicos and Sanofi. Its co-authors had no disclosure.
Scientific session of the American College of Cardiology (ACC) 2021: Summary 411-16. Filed May 17, 2021.
This article originally appeared on MDEdge.com.