BACKGROUND: Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown.
METHODS: In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m2 of body-surface area. The primary composite outcome was kidney failure (defined as end-stage kidney disease, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes) or a sustained decrease of at least 40% in the eGFR from baseline over a period of at least 4 weeks. The key secondary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
RESULTS: The median follow-up was 2.6 years. A primary outcome event occurred in 458 of 2867 patients (16.1%) in the finerenone group and in 579 of 2867 patients (20.6%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001). A key secondary outcome event occurred in 367 patients (12.7%) in the finerenone group and in 420 patients (14.6%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.03). The overall incidence of adverse events and serious adverse events was similar in the two groups. Hyperkalemia-related adverse events occurred more frequently with finerenone than with placebo (18.3% vs. 9.0%), as did severe hyperkalemia (2.1% vs. 0.9%). Treatment discontinuation due to hyperkalemia occurred in 1.7% of the patients in the finerenone group and in 0.6% of those in the placebo group.
CONCLUSIONS: Among patients with CKD and type 2 diabetes, finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. The incidence of hyperkalemia-related adverse events was higher with finerenone.
BACKGROUND: Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown.
METHODS: In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m2 of body-surface area. The primary composite outcome was kidney failure (defined as end-stage kidney disease, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes) or a sustained decrease of at least 40% in the eGFR from baseline over a period of at least 4 weeks. The key secondary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
RESULTS: The median follow-up was 2.6 years. A primary outcome event occurred in 458 of 2867 patients (16.1%) in the finerenone group and in 579 of 2867 patients (20.6%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001). A key secondary outcome event occurred in 367 patients (12.7%) in the finerenone group and in 420 patients (14.6%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.03). The overall incidence of adverse events and serious adverse events was similar in the two groups. Hyperkalemia-related adverse events occurred more frequently with finerenone than with placebo (18.3% vs. 9.0%), as did severe hyperkalemia (2.1% vs. 0.9%). Treatment discontinuation due to hyperkalemia occurred in 1.7% of the patients in the finerenone group and in 0.6% of those in the placebo group.
CONCLUSIONS: Among patients with CKD and type 2 diabetes, finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. The incidence of hyperkalemia-related adverse events was higher with finerenone.
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