Among patients with diabetes and kidney disease the addition of the medication finerenone compared with placebo resulted in improvement in albuminuria, according to a study in the Sept. 1 issue of JAMA.
There is an unmet need to safely manage albuminuria without adversely affecting potassium levels in patients with type 2 diabetes mellitus who have a clinical diagnosis of diabetic kidney disease, according to information in the article.
George L. Bakris, MD, of University of Chicago Medicine, and colleagues randomly assigned 823 patients (821 received study drug) with diabetes and elevated albuminuria who were receiving an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) to varying doses of the drug finerenone or placebo. In previous research, finerenone reduced albuminuria in patients with chronic kidney disease and heart failure, with a lower incidence of hyperkalemia (higher than normal levels of potassium in the blood) compared to another medication. The current study was conducted at 148 sites in 23 countries, and was was funded by Bayer HealthCare AG.
At study entry, 37% of patients treated had very high albuminuria. The researchers found that finerenone reduced albuminuria at day 90 in a dose-dependent manner, with a significant reduction in albuminuria (urinary albumin-creatinine ratio) ranging from 21% to 38% in the finerenone dos-age groups of 7.5 to 20 mg/d compared with placebo.
The outcome of hyperkalemia leading to discontinuation was not observed in the placebo and finerenone 10-mg/d groups; discontinuation in the finerenone 7.5-, 15-, and 20-mg/d groups were 2.1%, 3.2%, and 1.7%, respectively.
There were no differences in the incidence of an estimated glomerular filtration rate (a measure of kidney function) decrease of 30% or more or in incidences of adverse events and serious adverse events between the placebo and finerenone groups.