Finerenone Associated With Decreased Risk of Cardiovascular Morbidity, Mortality in Patients With Diabetic Kidney Disease

Finerenone may reduce the risk of cardiovascular morbidity and mortality in patients with mild-to-moderate kidney disease and type 2 diabetes, according to a study published in the New England Journal of Medicine. Diabetic kidney disease develops in nearly 40% of patients with diabetes and serves as the leading cause of chronic kidney disease worldwide, according to the study.

The trial previously reported that finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), slowed the progression of kidney disease and improved cardiovascular outcomes in patients with predominantly advanced kidney disease and type 2 diabetes.

The study enrolled patients with type 2 diabetes and mild-to-moderate kidney disease treated with an optimized renin–angiotensin system (RAS) blockade, with a total of 7437 patients across 48 countries participating in the study. Participants were randomized 1-to-1 to receive either oral finerenone (10 or 20 mg) or placebo once daily.

The average age of patients enrolled was 64.1 years and 69.4% were men. The study’s primary endpoint was a composite of time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.

During a median follow-up after 3.4 years, the primary endpoint was reached by 12.4% of patients in the finerenone group and 14.2% in the placebo group, translating to a 13% reduction of risk for patients using finerenone compared to placebo. The cardiovascular benefit is mainly attributable to a 29% reduction in hospitalization for heart failure.

The secondary endpoint, a composite of kidney failure, sustained decrease in estimated glomerular filtration rate by 40% or more from baseline, or renal death, occurred in 9.5% of participants in the finerenone group and 10.8% of the placebo group. End stage kidney disease occurred in 0.9% of patients receiving finerenone compared to 1.3% of patients receiving placebo.

In terms of safety, the overall frequency of adverse events (AEs) was not different between the treatment groups. Incidents of hyperkalemia were more frequent for patients in the finerenone cohort, with 10.8% in the finerenone arm experiencing this effect compared to 5.3% of the placebo group. However, subsequent discontinuation of the study drug was low, with only 1.2% of the finerenone group discontinuing treatment because of an AE.

“Finerone improved cardiovascular outcomes in patients with mild-to-moderate kidney disease and type 2 diabetes treated with optimized RAS blockade and with well-controlled blood pressure and diabetes,” said Bertram Pitt, MD, in a press release. “The benefits of finerenone were consistent across eGFR and urine albumin-to-creatinine ratio categories. Together with FIDELIO-DKD, the results support the use of finerenone to improve cardiorenal outcomes across the spectrum of kidney disease and type 2 diabetes.”

REFERENCE

Finerenone improves outcomes in patients with mild-to-moderate kidney disease and diabetes [news release]. EurekAlert; August 30, 2021. Accessed August 31, 2021. https://www.eurekalert.org/news-releases/926802