ADA 2021: Baseline Insulin Use May not Impact Benefits of Finerenone in Patients with CKD, T2D

Finerenone has a beneficial effect on kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), irrespective of insulin use at baseline, according to a new subgroup analysis of the FIDELIO-DKD trial.

The new findings were presented at the American Diabetes Association 81st Scientific Sessions (ADA 2021), held virtually between June 25-29, 2021.

Finerenone is a novel, selective, nonsteroidal mineralocorticoid receptor antagonist that was found to significantly reduce the risk of kidney and CV outcomes in patients with CKD and T2D with no effect on blood glucose in the FIDELIO-DKD trial.

FIDELIO-DKD was a randomized controlled trial that enrolled 5674 patients with T2D, urinary albumin-to-creatinine ratio (UACR) between 30-5000 mg/g, estimated glomerular filtration rate (eGFR) from 25-74 mL/min/1.73 m2, and receiving optimized RAS blockade. Participants were randomized to finerenone (10 mg daily increasing to 20 mg daily) or placebo.

The primary endpoint was time to kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death. The secondary endpoint was a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure).

The aim of the current subgroup analysis was to evaluate the impact of baseline insulin use (including insulin analogs) on composite kidney and CV outcomes and safety in patients treated with finerenone or placebo.

Of the 5674 patients analyzed from FIDELIO-DKD, 3637 (64.1%) were treated with insulin or insulin analogues at baseline. After the study started, insulin was initiated as a new medication in 469 (8.3%) of patients.

Patients treated with insulin at baseline had a higher A1c and a longer duration of T2D, with higher proportions of statin and GLP-1 receptor agonist use, and lower use of other anti-hyperglycemic agents than those who were not. Finerenone did not affect A1c during the trial period.

Researchers found that finerenone reduced the relative risk of a primary composite kidney outcome by 18% and the key secondary composite CV outcome by 14% compared to placebo. These results were consistent regardless of insulin use at baseline (p-interaction=0.56 and 0.33, respectively).

Results also showed that adverse events were similar between finerenone and placebo, independent of insulin use. Hyperkalemia was increased with finerenone, but its clinical impact was minimal, according to researchers.

“This subgroup analysis suggests finerenone may be an important advance in treatment for patients with CKD and T2D, independent of insulin use,” concluded authors in the poster presentation.

Reference: Rossing P, Agarwal R, Anker S, et al. Efficacy and safety of finerenone in patients with CKD and T2D by baseline insulin treatment. American Diabetes Association Presented Friday, June 25, 2021, 405-P.

For a Patient Care Online conversation with FIDELIO-DKD lead investigator George Bakris, MD, please click here.

The original study, Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes was published in December 2020 in the New England Journal of Medicine.