Finerenone Slows Renal Decline, Improves CV Outcomes in FIDELIO-DKD

In patients with type 2 diabetes (T2D) who have chronic kidney disease (CKD), treatment with the experimental drug finerenone slowed progression of CKD and reduced risk of cardiovascular events vs placebo.

In the phase 3 FIDELIO-DKD trial, finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist (MRA), slowed the progression of kidney disease by 18% over a median of 2.6 years compared to current standard of care. The results were simultaneously presented today at the American Society of Nephrology’s Kidney Week 2020 and published in the New England Journal of Medicine. ​

Study authors, led by George Bakris, MD, professor of medicine at the University of Chicago and director of Comprehensive Hypertension Center at the University of Chicago Medicine, randomly assigned more than 5000 patients with CKD and T2D in a 1:1 fashion to receive finerenone or placebo. All patients were on maximum renin-angiotensin system (RAS) blockade, adjusted prior to randomization, as well as antihyperglycemic therapy.

The primary composite outcome was kidney failure, a sustained reduction of at least 40% in the eGFR from baseline over a period of at least 4 weeks, or death from renal causes. The key secondary composite outcome was death from cardiovascular (CV) causes, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for heart failure (HHF). Both outcomes were assessed in a time-to-event analysis.

During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001). At 36 months, the number needed to treat to prevent a primary composite endpoint event was 29 [CI 16-166].

Finerenone also significantly reduced the risk of the key secondary composite outcome (CV death, nonfatal MI, non-fatal stroke or HHF) compared to placebo by 14% (relative risk reduction, HR 0.86 [CI, 0.75-0.99; p=0.0339]) over the median 2.6 year follow-up.

"We now have evidence that doctors can safely slow diabetic kidney disease progression and reduce cardiovascular event rates using finerenone, a novel nonsteroidal mineralocorticoid receptor blocker, not yet approved by the FDA. This is very important for a group of patients who've historically had very few options.

"This promising target for a new therapy means patients are able to delay dialysis and, in turn, further delay the possible need for kidney transplants. The reduction in cardiovascular events is an added bonus to slowing kidney disease progression," said Bakris, in a statement.

The authors report that the overall frequency of adverse events was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2.3% and 0.9%, respectively).