DALLAS, Nov. 17, 2020 -- The investigational medication finerenone reduced the risk of heart attack, stroke, heart failure and other negative cardiovascular events in patients with chronic kidney disease and Type 2 diabetes, according to late-breaking research presented at the American Heart Association's Scientific Sessions 2020. The virtual meeting is Friday, November 13-Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide. The manuscript of this study is simultaneously published today in Circulation, journal of the American Heart Association.
In the largest trial of its kind to-date, the study, "Finerenone and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes" (FIDELIO-DKD), found that finerenone reduced the risk of cardiac events for patients regardless of whether they had a history of heart disease or not. Finerenone - a novel, nonsteroidal, selective mineralocorticoid receptor antagonist - reduced both the risk of worsening kidney disease and risk of death related to heart problems.
"We are pleased to see that finerenone could provide a meaningful treatment option for patients who are battling chronic conditions," said Gerasimos Filippatos, M.D., the study's lead author and a professor of cardiology at the National and Kapodistrian University of Athens in Greece.
The FIDELIO-DKD study is a phase III, randomized, double-blind, placebo-controlled trial that enrolled nearly 6,000 patients (average age 66; 70.2% male) at more than 900 sites in 48 countries. The goal was to investigate finerenone in patients with chronic kidney disease and Type 2 diabetes since these patients face significant risk of cardiovascular disease and death. Cardiovascular events like heart attacks, heart failure and stroke are some of the leading causes of death in this patient group.
After follow-up of more than 2-1/2 years, researchers found a daily, oral treatment at 10 mg or 20 mg with finerenone reduced by 14% the risk of cardiovascular events for patients who already had a history of heart disease and for those who had no previous history. It also reduced the rate of death, heart attack, stroke and hospitalization for heart failure among patients with chronic kidney disease and Type 2 diabetes.
There are additional phase III trials of finerenone in progress.
Co-authors are Stefan D. Anker, M.D.; Rajiv Agarwal, M.D., M.S.; Bertram Pitt, M.D.; Peter Rossing, M.D.; Luis M. Ruilope, M.D.; Peter Kolkhof, Ph.D.; Patrick Schloemer, Ph.D.; Amer Joseph, M.B.B.S.; Ingo Tornus, Ph.D.; and George L. Bakris, M.D. Author disclosures are in the abstract. The study was funded by Bayer AG.
Presentation: LBS.07 - Randomized Trials - Brain, Kidney, and Heart