An analysis of FIDELIO-DKD demonstrates the benefits of finerenone use was consistent regardless of baseline insulin use among patients with type 2 diabetes and CKD included in the phase 3 trial.
New data from the phase 3 FIDELIO-DKD trial detail the impact of Bayer’s selective, nonsteroidal mineralocorticoid receptor antagonist finerenone based on whether or not a patient was using insulin therapy.
One of a trio of prespecified FIDELIO-DKD analyses presented at the American Diabetes Association’s 81st Scientific Sessions (ADA 2021), results of the prespecified analysis suggest finerenone had a beneficial effect on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes, irrespective of insulin use at baseline.
“We thought it was important to study as insulin can be sodium- and fluid-retaining. Therefore, there could be an interaction, but it seems that finerenone works exactly the same whether or not you are on insulin. (In the trial) 60% were on insulin. So, in a sense, this was a more robust analysis than the previous analysis on SGLT2 or GLP-1s,” said Peter Rossing, 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).
A novel agent showing promise for treatment of diabetic kidney disease, finerenone has been in the spotlight since the original results of the phase 3 trial was presented at the American Society of Nephrology’s Kidney Week 2020. At ADA 2021, 3 prespecified analyses detailed the impact of background SGLT2 inhibitor use, GLP-1 receptor agonist use, and insulin use on the effects of finerenone among patients in the trial.
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 demonstrated finerenone use was associated with an 18% reduction in risk for progression of CKD and a 14% reduction in the composite cardiovascular endpoint versus placebo therapy. The other prespecified analyses presented at ADA 2021 suggested results were consistent regardless of SGLT2 inhibitor use or GLP-1 receptor agonist use, with the SGLT2 inhibitor analysis suggesting combined use could have an additive effect.
The prespecified analysis assessing effects by baseline insulin use sought to compare the effects of finerenone among the 3637 patients using insulin therapy at baseline to the 2037 patients not using insulin. Compared to those not using insulin or insulin analogues at baseline, insulin users had a higher baseline HbA1c, longer duration of diabetes, greater proportions of statin and GLP-1 receptor agonist use, and lower use of other anti-hyperglycemic agents.
Investigators pointed out initial analyses indicated finerenone had no impact on HbA1c during the trial. Additionally, no between-group interaction was seen for the effect of finerenone on primary renal (HR, 0.85 [95% CI 0.73-0.98] with insulin; HR, 0.79 [95% CI 0.64-0.96] without insulin; P for interaction=.56) and key secondary cardiovascular outcomes (HR, 0.82 [95% CI 0.69-0.97] with insulin; HR, 0.95 [95% CI 0.74-1.23] without insulin; P for interaction=.33). Analysis of safety data demonstrated incidence of hyperkalemia events was similar between groups.
For more on the results of this prespecified 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 Baseline Insulin Treatment,” was presented at ADA 2021.