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The double-blind trial reported on long-term cardiovascular and kidney outcomes in patients with chronic kidney disease and type 2 diabetes.
Short-term trials have demonstrated an association between administration of the nonsteroidal, selective mineralocorticoid receptor antagonist and reduction in albuminuria. However, there has been a need to assess the treatment’s effects on kidney and cardiovascular outcomes.
Therefore, a team led by George Bakris, MD, Department of Medicine, University of Chicago, conducted a double-blind trial that examined the effects finerenone after a median follow-up of 2.6 years.
Enrolled patients had both chronic kidney disease and type 2 diabetes. They either had a urinary albumin-to-creatinine ratio of 30-<300, an estimated glomerular filtration rate (eGFR) of 25-<60 ml per minute per 1.73 m2 of body surface area, and diabetic retinopathy, or a urinary albumin-to-creatinine ratio of 300-5000 and an eGFR of 25-<75 ml per minute per 1.73 m2.
The 5734 participants were then randomized 1:1 to receive either finerenone or placebo. All patients were treated with renin-angiotensin system blockade.
Of the entire population, 70.2% were male, and the mean age was 65.6 years old.
Thus, their primary composite outcome was kidney failure, sustained decrease of ≥40% in the eGFR from baseline, or death from renal causes.
The key secondary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization.
Both outcomes were assessed in a time-to-event analysis.
The results showed that a primary outcome occurred in 17.8% of patients in the finerenone cohort and 21.1% in the placebo cohort (hazard radio [HR], 0.82; 95% CI, 0.73-0.93; P = .001). The investigators noted that the effects of finerenone on the primary outcome were generally consistent across prespecified subgroups.
Furthermore, a key secondary outcome event occurred 13.0% and 14.8% of finerenone- and placebo-treated patients, respectively (HR, 0.86; 95% CI, 0.75-0.99; P = .03). Although the secondary outcome components were lower with finerenone than with placebo, nonfatal stroke had a similar incidence between the groups.
Bakris and team reported that the overall frequency of adverse events was similar in the two groups. Serious adverse advents occurred in 31.9% of patients in the finerenone group—compared with 34.3% of those in the place group.
However, it was noted that hyperkalemia-related adverse events had a two-fold higher incidence with finerenone than with placebo (18.3% and 9.0%, respectively). Further, the frequency of hyperkalemia leading to discontinuation of the trial was 2.3% with finerenone and 0.9% with placebo.
“In a patient population with multiple coexisting conditions and advanced CKD who were at high risk for kidney and cardiovascular events, the benefits of finerenone were observed after 12 months for the kidney outcome and as early as 1 month for the cardiovascular outcome, and these benefits persisted throughout the trial,” the investigators said.
Some of the study limitations were the exclusion of patients with nonalbuminuric chronic kidney disease as well as those with kidney disease not caused by type 2 diabetes. Furthermore, only 4.7% of the study population identified themselves as Black. Thus, the investigators acknowledged that the generalizability of the findings may be limited.
They alluded to the ongoing Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial, which will assess the drug’s cardiorenal efficacy and safety in populations with type 2 diabetes and less advanced chronic kidney disease.
The study, “Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes,” was published online in The New England Journal of Medicine.