FIGARO-DKD: Finerenone reduces CV death risk in diabetic kidney disease
The non-steroidal mineralocorticoid receptor antagonist finerenone significantly reduced risk for cardiovascular death and non-fatal CV events compared with placebo in adults with chronic kidney disease and type 2 diabetes, top-line data show.
Data from the phase 3 FIGARO-DKD study showed finerenone (Bayer) significantly reduced the composite risk of time to first occurrence of CV death or non-fatal CV events, defined as myocardial infarction, stroke, or hospitalization for heart failure.
“Up to 40% of people with type 2 diabetes develop chronic kidney disease, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure,” Luis M. Ruilope, MD, professor at the public health and preventative medicine department of the Autonoma University and co-principal investigator of the FIGARO-DKD trial, said in a press release. “The FIGARO-DKD study delivers important insights into the potential effects on cardiovascular outcomes of finerenone in the management of people with chronic kidney disease and type 2 diabetes.”
As Healio previously reported, the FDA granted priority review to a new drug application for finerenone for the treatment of diabetic kidney disease. That action followed results from the phase 3 FIDELIO-DKD study, which demonstrated the drug was effective for delaying the progression of CKD and reducing risk for CV events in participants with type 2 diabetes.
FIGARO-DKD, a randomized, double-blind, placebo-controlled trial, included more patients with earlier stage CKD and type 2 diabetes compared with FIDELIO-DKD, which was the first of two phase 3 studies investigating finerenone in patients with CKD and type 2 diabetes. Approximately 7,400 participants from 47 countries were randomly assigned to finerenone 10 mg or 20 mg orally once daily or placebo added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of the guideline directed therapies angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.
“With the positive outcome of the composite primary endpoint of the FIGARO-DKD trial, we have reached a significant milestone for finerenone by completing the largest phase 3 clinical trial program to date focusing on chronic kidney disease and type 2 diabetes across a broad range of disease severity,” Christian Rommel, MD, member of the executive committee of Bayer AG’s pharmaceutical division and head of research and development, said in the release. “We are pleased to see that the FIGARO-DKD data further support evidence generated in the FIDELIO-DKD trial with respect to reducing the risk of the composite of cardiovascular death and non-fatal cardiovascular events or outcomes in patients with chronic kidney disease and type 2 diabetes.”
In an analysis of new FIDELIO-DKD data presented at the American Heart Association Scientific Sessions in November and reported by Healio, researchers reported finerenone reduced the incidence of CV events regardless of CVD status among adults with CKD and type 2 diabetes.
“Finerenone not only slowed diabetic kidney disease progression, but protected against the risk for CV events related to atherosclerosis as well as heart failure, given no interaction with the prespecified endpoint,” George L. Bakris, MD, professor of medicine and director of the American Heart Association-accredited Comprehensive Hypertension Center at the University of Chicago Medicine and senior author of the FIDELIO study, told Healio before presenting the AHA data. We now have another agent in our arsenal to preserve kidney and cardiac function.”
The clinical data from FIGARO-DKD will be presented at an upcoming scientific meeting, Bayer said in the release.