Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. Finerenone treatment lowered the risk of chronic kidney disease (CKD) progression in patients diagnosed with type 2 diabetes and advanced CKD.

2. Treatment with finerenone also lowered the risk of cardiovascular events in patients diagnosed with type 2 diabetes and advanced CKD.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

The leading cause of chronic kidney disease (CKD) is type 2 diabetes. Guidelines suggest that the management of CKD in patients diagnosed with type 2 diabetes should include controlling hypertension, hyperglycemia, and the use of a renin-angiotensin system (RAS) blocker. However, despite these recommendations, these patients still possess the risk of CKD progression. A new treatment using finerenone, a nonsteroidal, selective mineralcorticoid receptor antagonist, can reduce urinary albumin-to-creatinine ratio in patients with CKD previously treated with a RAS blocker. As such, this study tested the efficacy of finerenone to slow CKD progression and reduce cardiovascular events in patients diagnosed with advanced CKD and type 2 diabetes. The study concluded that finerenone treatment lowered the risk of CKD progression and cardiovascular events within the treated population. The randomized control trial was limited by the racial demographics of the study population. Since less than 5% of participants identified themselves as Black, the generalizability of the results is restricted. Nonetheless, this study’s results are significant, and its findings highlight the benefit of a therapy to preserve kidney function.

In-Depth [randomized controlled trial]:

This randomized control trial enrolled 5,734 participants in a multicenter study in 48 countries. Participants included in the study were ≥18 years of age, diagnosed with type 2 diabetes and CKD, and treated with a RAS inhibitor at the maximum dose. Participants with a serum potassium level greater than 4.8 mmol per liter were excluded from this study. The participants were randomized in a 1:1 ratio to receive oral, 20 mg, once daily dose of finerenone or placebo, respectively. The primary end point was a composite of kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease of at least 40% for at least 4 weeks, or death from renal causes. Kidney failure was defined as end-stage kidney disease or and eGFR of less than 15 mL per minute per 1.73m2. The median follow-up for the trial was 2.6 years, but 822 participants in the finerenone group (29.0%) and 801 participants in the control group (28.2%) discontinued the trial regimen. The incidence of the primary end point occurred in 504 participants in the finerenone group (17.8%) compared to 600 participants in the control group (21.1%). The incidence of the primary end point was significantly lower in the finerenone group compared to the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001). The absolute between-group difference was 3.4 percentage points (95% CI, 0.6 to 6.2), and the number of participants requiring finerenone treatment to prevent one primary outcome was 29 (95% CI, 16 to 166). Additionally, death from cardiovascular causes, nonfatal myocardial infarctions, nonfatal stroke, or hospitalization for heart failure occurred in 367 participants in the finerenone group (13.0%) compared to 420 participants in the placebo group (14.8%). The risk for cardiovascular events was significantly lower in the finerenone group compared to the control group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.03). Finally, the serious adverse events incidence was similar between both groups (finerenone group, 31.9%; placebo group, 34.3%). Specifically, hyperkalemia-related adverse events were twice as frequent in the finerenone group (18.3%) compared to the placebo group (9.0%), and the frequency of hyperkalemia leading to treatment discontinuation was higher in the finerenone group (2.3%) compared to the placebo group (0.9%). Taken together, finerenone treatment lowered the risk of CKD progression and cardiovascular events in participants diagnosed with type 2 diabetes and advanced CKD.

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