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A FIDELIO-DKD analysis presented at ADA 2021 suggests the renal and cardiovascular benefits of finerenone were consistent, irrespective of background GLP-1 RA use and indicate the presence of both was associated with even greater reductions in albuminuria.
An analysis of the FIDELIO-DKD trial is providing clinicians with insight into the effects of finerenone based on use of background GLP-1 receptor agonist (GLP-1RA) therapy.
With the popularity of GLP-1RA use having grown since FIDELIO-DKD began in 2015, data from the prespecified analysis demonstrate use of finerenone resulted in consistent kidney and cardiovascular benefits when compared against placebo, irrespective of GLP-1RA use among patients in the phase 3 trial.
“There was consistent kidney and cardiovascular benefit of finerenone compared to placebo, irrespective of GLP-1 receptor agonist use,” said Peter Rossing, MD, DMSc, Head of Complications Research and Chief Physician at Steno Diabetes Center, who presented the analysis at the American Diabetes Association’s 81st Scientific Sessions (ADA 2021). “There was a reduction in albuminuria with finerenone in both groups, which could suggest that finerenone can reduce albuminuria further on top of GLP-1 receptor agonist use.”
One of a trio of prespecified analyses of FIDELIO-DKD assessing the effects of finerenone according to background therapy, results of the current study provide some of the first insight into the effects of Bayer’s novel, non-steroidal, selective mineralocorticoid receptor agonist based on background therapy use. The other studies presented at ADA 2021 examined use according to SGLT2 inhibitor use and background insulin therapies.
Briefly, FIDELIO-DKD was a randomized, double-blind, placebo-controlled trial enrolling 5674 patients with type 2 diabetes, a UACR from 30-5000 mg/g, an eGFR from 25-74 mL/min/1.73min2, and receiving optimized RAAS blockade that was originally presented at the American Society of Nephrology’s Kidney Week 2020. Results of the trial indicated finerenone use was associated with an 18% reduction in risk for progression of CKD and a 14% reduction in the composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
Of the 5674 patients included in FIDELIO-DKD, 394 (6.9%) were receiving a GLP-1RA at baseline. Investigators noted 368 (6.5%) patients began therapy with a GLP-1RA during the course of the trial. Compared to their counterparts not treated with GLP-1RAs, those using GLP-1RAs had a higher BMI, higher HbA1c, greater diuretic use, greater statin use, lower median UACR, and a lower prevalence of cardiovascular disease.
Upon analysis, results indicated no between-group differences exist for interaction between the kidney and cardiovascular outcomes in the trial. Additionally, results suggested reductions in UACR seen in the trial were independent of GLP-1RA use, with LS-means of 0.63 (95% CI, 0.56-0.70) in the GLP-1RA group and 0.69 (95% CI, 0.67-0.72) in the group not using GLP-1RAs (P for interaction=.20). Investigators also pointed out safety analysis indicated incidence of hyperkalemia events was similar among both groups of patients.
For more on the results of this secondary analysis of FIDELIO-DKD, Endocrinology Network reached out to Rossing and that conversation is the subject of this ADA 2021 House Call.
This study, “Efficacy and Safety of Finerenone in Patients with CKD and T2D by GLP-1RA Treatment,” was presented at ADA 2021.