Short-term studies have shown an association between the administration of non-steroidal selective mineralocorticoid receptor antagonists and decreased albuminuria. However, it was necessary to evaluate the effect of treatment on renal and cardiovascular outcomes.
That’s why a team led by Dr. George Bakris of the University of Chicago School of Medicine conducted a double-blind study examining the effects of finelenone after a median follow-up of 2.6 years.
The enrolled patients had both chronic kidney disease and type 2 diabetes. They had a urinary albumin to creatinine ratio of 30- <300 and an estimated glomerular filtration rate (eGFR) of 2.5- <60 ml / min / 1.73 m.2 Body surface area, diabetic retinopathy, or urinary albumin to creatinine ratio of 300-5000, eGFR of 25- <75 ml / min / 1.73 m2..
The 5734 participants were then randomized 1: 1 and received either finnernon or placebo. All patients were treated with renin-angiotensin blockade.
70.2% of the total population was male, with an average age of 65.6 years.
Therefore, their major combined result was renal failure, a persistent decrease. ≥40% of eGFR from baseline, or death from kidney cause.
The major secondary compound outcomes were death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or hospitalization.
Both results were evaluated in a time analysis to the event.
The results showed that the primary outcome occurred in 17.8% of patients in the Finnernon cohort and 21.1% in the placebo cohort (hazard radio). [HR], 0.82; 95% CI, 0.73-0.93; P = .001). The researchers noted that the effect of finelenone on primary outcomes was largely consistent among pre-designated subgroups.
In addition, major secondary outcome events occurred in 13.0% and 14.8% of patients treated with finelenone and placebo, respectively (HR, 0.86; 95% CI, 0.75-0.99; P = .03). The secondary outcome component was lower with finelenone than with placebo, but non-fatal stroke showed similar incidences among groups.
Bacris and the team reported that the overall frequency of adverse events was similar in the two groups. Serious adverse manifestations occurred in 31.9% of patients in the fillenon group. In contrast, 34.3% of patients in the place group.
However, it was noted that the incidence of hyperkalemia-related adverse events was twice as high with finelenone as with placebo (18.3% and 9.0%, respectively). In addition, the frequency of hyperkalemia leading to study discontinuation was 2.3% for finelenone and 0.9% for placebo.
“In a population of patients with multiple coexistence and advanced CKD who are at high risk for renal and cardiovascular events, as early as 12 months for renal outcomes and 1 month for cardiovascular outcomes, finelenone Benefits were observed and persisted throughout the trial, “the researchers said.
Some of the limitations of the study were the exclusion of patients with non-albuminurian chronic kidney disease and patients with kidney disease not caused by type 2 diabetes. In addition, only 4.7% of the surveyed population identified themselves as black. Therefore, researchers acknowledged that the generalizability of findings could be limited.
They hinted at an ongoing Finerenone (FIGARO-DKD) trial in reducing cardiovascular mortality and morbidity in diabetic kidney disease.
the study, “Effect of Finnerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes, ”Was published online The New England Journal of Medicine.
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