Finerenone slows CKD progression in diabetes patients, finds NEJM study
https://medicaldialogues.in/nephrology/news/finerenone-slows-ckd-progression-in-diabetes-patients-finds-nejm-study-70779
Researchers have found in phase III FIDELIO-DKD trial that an investigational anti-mineralocorticoid agent slowed chronic kidney disease (CKD) progression in people with type 2 diabetes. The drug finerenone had tangible renal and cardiovascular benefits for patients with chronic kidney disease and type 2 diabetes.
The
findings were simultaneously published in the New England Journal of Medicine
and presented at the American Society of Nephrology's Kidney Week 2020
conference,
The 5,700-person phase III trial was led by George Bakris, MD, Professor of
Medicine at the University of Chicago and Director of the Comprehensive
Hypertension Center at the University of Chicago Medicine. Taking place at more
than 1,000 sites in 48 countries, the study was the largest-ever research
effort into the disease that affects millions of people in the U.S. alone. More
than 1/4 of adults with diabetes will eventually develop chronic kidney
disease, making diabetes the leading cause of kidney failure.
"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," said Bakris. "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."
Finerenone, which is made by Bayer, is a non-steroidal, selective
mineralocorticoid receptor (MR) antagonist. The drug is not yet approved for
use, but is being investigated in a number of clinical trials, including FIGARO
that will be finished next year on cardiovascular outcomes. It directly targets
and blocks receptors that contribute to inflammation and scarring of the heart
and kidney. Kidneys filter waste and water from the body and also play role in
controlling blood pressure and when they're damaged can lead to a backup of
waste and fluid in the body.
Called FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease
prOgression in Diabetic Kidney Disease), the study showed the drug was significantly
better than a placebo, slowing the progression of kidney disease by 18% over a
median of 2.6 years compared to current standard of care.
While patients who received finerenone did report higher levels of potassium (18% versus 9% with a placebo), serious potassium-related side effects requiring study discontinuation were infrequent and occurred in 2.8% of patients versus 0.9% of the control group. High levels of potassium can lead to cardiac rhythm problems.
Bayer
announced earlier this year that the trial met its composite primary renal
endpoint and its composite key secondary cardiovascular endpoint. But full
findings of the trial weren't released until Oct. 23. The trial was randomized,
double-blind and placebo-controlled.