Ann Arbor, MI—Cardiovascular risk with type 2 diabetes is heightened in patients who also have chronic kidney disease (CKD). A new study describes how the risks of cardiovascular events and new-onset heart failure are exacerbated as the urinary albumin-to-creatinine ratio—with albumin measured in milligrams and creatinine measured in grams exceeding 10 and the estimated glomerular filtration rate (eGFR) decreasing below 75 mL per minute per 1.73 m2 of body-surface area.
“Most patients with CKD are at higher risk for cardiovascular events than for kidney failure. Thus, it is important to identify and treat CKD in order to reduce the high cardiovascular and heart failure burden of CKD in patients with type 2 diabetes,” according to the University of Michigan School of Medicine–led authors.
The report published in the New England Journal of Medicine points out that the “mineralocorticoid receptor overactivation is associated with kidney and cardiovascular diseases, which often coexist as cardiorenal disease.”
The authors add that finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, improved markers of kidney and cardiovascular damage in preclinical models and in patients with CKD in phase II studies. In the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial, the drug improved kidney outcomes in patients with predominantly stage III or IV CKD with severely elevated albuminuria and type 2 diabetes, a population with high kidney risk.
Now, in the recent Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial, researchers determined that finerenone reduces the risk of cardiovascular morbidity and mortality in patients with mild-to-moderate kidney disease and type 2 diabetes. Results were presented at the European Society Cardiology 2021 conference in August.
“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 lead author Bertram Pitt, MD, of the University of Michigan School of Medicine.
“The benefits of finerenone were consistent across eGFR and urine albumin-to-creatinine ratio (UACR) 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.”
Background information in the article describes how diabetic kidney disease occurs in about 40% of patients with diabetes and is the leading cause of CKD worldwide. While some patients progress to end-stage renal disease, more commonly those patients die from cardiovascular diseases and infections before needing kidney replacement therapy.
FIGARO-DKD enrolled 7,437 patients in 48 countries and randomized them 1:1 to oral finerenone (10 or 20 mg) or placebo once daily. Participants had an average age of 64.1 years, and 69.4% were men. Designated as the primary endpoint was a cardiovascular composite of time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.
During a median follow-up of 3.4 years, the primary endpoint occurred in 458 (12.4%) and 519 (14.2%) patients in the finerenone and placebo groups, respectively. The researchers report that the relative risk of this endpoint was significantly reduced by 13% with finerenone versus placebo (hazard ratio [HR] 0.87; 95% confidence interval [CI] 0.76-0.98; P =.03).
Researchers point out that the benefit was “driven primarily by a lower incidence of hospitalization for heart failure (hazard ratio, 0.71; 95% CI, 0.56 to 0.90).” They add that the overall frequency of adverse events did not differ significantly between groups, although the necessity of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone (1.2%) than with placebo (0.4%).
“Among patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria, finerenone therapy improved cardiovascular outcomes as compared with placebo,” the industry-funded study concludes.
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