Finerenone effective in reducing cardiac, ESKD risk in patients with diabetes
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Data presented at ASN Kidney Week showed the mineralocorticoid receptor inhibitor antagonist finerenone was effective in reducing cardiac risk and slowing the progression of chronic kidney disease in patients with diabetes.
“Current therapies predominately have hemodynamic and metabolic effects and do not target inflammatory and fibrotic complications,” Rajiv Agarwal, MD, MBBS, FASN, professor of medicine at Indiana University School of Medicine, said in his presentation of the study results. “The rationale for the FIDELIO-[diabetic kidney disease] DKD trial focuses on the mineralocorticoid receptor. Overactivation of the mineralocorticoid receptor causes inflammation and fibrosis.”
The study included 5,734 patients at more than 1,000 sites worldwide diagnosed with CKD and type 2 diabetes assigned to either oral finerenone or placebo. The mean patient age in the study was 65.6 years; 70.2% were male patients. Mean eGFR was 44.3 mL/min/1.73 m2 at baseline. Almost 90% of patients had severely elevated albuminuria.
The primary study outcome was time to kidney failure, sustained eGFR decline greater than or equal to 40% from baseline or renal death. The key secondary outcome was time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalization.
In patients prescribed finerenone, researchers discovered a reduced risk of the composite primary endpoint of time to kidney failure and a sustained decrease of estimated eGFR greater than or equal to 40% from baseline during a period of at least 4 weeks. Investigators also found a 18% reduced risk of renal death during a median duration of follow-up of 2.6 years when added to maximum tolerated dose of guideline-directed therapy.
Patients who were on finerenone also saw a 31% reduction in albuminuria, sustained during the trial. “The improvement in albuminuria occurred despite only modest effects on blood pressure [during the trial], and there was no difference in A1C,” Agarwal, who chairs the FIDELIO study adjudication committee, said.
The frequency of serious adverse events was lower in patients treated with finerenone (31.9%) compared to placebo (34.3%), the researchers reported. Overall hyperkalemia-related adverse events occurred more often in patients who received finerenone compared with patients who received placebo (18.3% vs. 9%). Hyperkalemia-related serious adverse events were 1.6% in the finerenone group and 0.4% in the placebo group, and investigators found no hyperkalemia-related death in either treatment group. Treatment was discontinued due to hyperkalemia in 2.3% of patients treated with finerenone compared with 0.9% in the placebo group.
Less than 5% of patients were on phosphate binders at the beginning of the trial, the researchers said.
“Despite available treatments focusing on hemodynamic and metabolic pathways, there is residual risk of kidney disease progression in patients with chronic kidney disease and type 2 diabetes. The findings from FIDELIO-DKD provide important evidence suggesting a potential new strategy for treating these patients,” George L. Bakris, MD, of the department of medicine in the American Heart Association Comprehensive Hypertension Center at the University of Chicago Medicine and principal investigator for the FIDELIO-DKD trial, said in a Bayer AG press release.
Results of the study were also reported in the New England Journal of Medicine.
Bayer AG’s phase 3 trial program with finerenone in patients with CKD and type 2 diabetes comprises the FIDELIO-DKD and the ongoing FIGARO-DKD trial, which is investigating the efficacy and safety of finerenone vs. placebo on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and type 2 diabetes across 47 countries.
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Agarwal R. #FR-OR51. Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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