ADA 2021: Renoprotection with Finerenone Consistent Regardless of SGLT2 Inhibitor Use

ADA 2021. A prespecified subanalysis of FIDELIO-DKD found primary and secondary renal and CV endpoints consistent whether or not SGLT2 inhibitors were on board at study baseline.

A predefined subanalysis of the FEDELIO-DKD study of the selective, nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with type 2 diabetes (T2D) suggests that the renal protection observed during the study was consistent regardless of concomitant SGLT2 inhibitor (SGLT2i) use.

Investigators also report improvement in urine albumin-to-creatinine ratio (UACR) in study patients who were taking SGLT2i at baseline, suggesting a potential additive effect when administered with finerenone.

The new findings were presented today at the American Diabetes Association 81st Scientific Sessions (ADA 2021).

FIDELIO-DKD studied the effects of finerenone in patients with chronic kidney disease (CKD) and T2D. The randomized controlled trial enrolled 5674 patients with T2D, UACR between 30-5000 mg/g, eGFR from 25-74 mL/min/1.73min2, and receiving optimized RAAS blockade. Participants were randomized to finerenone (10 mg daily increasing to 20 mg daily) or placebo.

Investigators found use of finerenone was associated with an 18% reduction in risk for progression of CKD and a 16% reduction in the secondary composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.

Of the original 5674 patients, 259 (4.6%) were receiving an SGLT-2i at baseline. The current analysis, led by Peter Rossing, MD, DMSc, Head of Complications Research and Chief Physician at Steno Diabetes Center in Copenhagen, demonstrated no difference in results based on SGLT-2i use at baseline for the primary (pinteraction= 0.21) and key secondary (pinteraction=0.46), CV outcomes.

Rossing et al also report that use of finerenone was associated with a reduction in UACR (ratio of LS-means 0.68, 0.65-0.71; p<0.0001) and that the reduction appeared to be greater among those also taking SGLT-2is at baseline (ratio of LS-means 0.75, 0.62-0.90; p=0.0024).

In a post-hoc analysis of treatment-emergent hyperkalemia events, fewer were observed in the group taking SGLT2is than in the group taking finerenone alone.

Reference: Rossing P, Agarwal R, Anker S, et al. Finerenone in patients with CKD and T2D by SGLT2i treatment: an analysis of the FIDELIO-DKD study. American Diabetes Association Presented Friday, June 25, 2021, 14-LB--2021.

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.