Diabetes patients often face a second problem: kidney disease. But a new medication may be here to help.
Researchers from the University of Chicago (U of C) tested the medication finerenone on patients with both diabetes and kidney disease. Finerenone was found to successfully lower the amount of albumin (a protein) in the urine of these patients, which can help slow the progression of kidney disease.
Ruby Elizabeth Kassanoff, MD, FACP, an internist at Baylor University Medical Center in Dallas, TX, told dailyRx News why this research is important for diabetes patients.
"This study looks at a new medication, currently in the clinical trial phase, which works by a slightly different mechanism than the existing [drugs that decrease the amount of protein excreted by the kidneys]," Dr. Kassanoff said. "It appears to have a very low risk of concerning side effects, so therefore may be an excellent alternative to currently available treatments. Additional studies are needed to confirm its safety and efficacy, but if it becomes commercially available, it may provide a promising new treatment option for diabetic patients."
Lead study author George L. Bakris MD, a professor of preventive medicine at U of C, and team looked at 823 patients with both diabetes and kidney disease. All patients had elevated levels of albumin in their urine.
According to these researchers, the primary purpose of this study was to determine what dose of finerenone was most effective and had the fewest negative side effects.
Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose).
Type 2 diabetes can also damage blood vessels in the kidneys, making it difficult for them to rid the blood of waste products. Protein, potassium, and other substances may then begin to build up in the urine and blood, which can cause more damage.
Protein in the urine is often the first sign of kidney disease.
Past research found that lowering albumin in the urine could slow kidney disease. It may also decrease the risk of heart problems.
However, many drugs used to lower albumin tend to increase the level of potassium in the blood. High potassium levels can cause serious heart problems.
"The main side effects from these medications ... are high blood levels of potassium and an acute worsening of kidney function," Dr. Kassanoff told dailyRx News. "Doctors are often reluctant to use these medications due to the risk of side effects, especially in patients who already have some decline in baseline renal function."
Dr. Bakris and team gave these patients either finerenone or a placebo.
Most patients were also taking drugs called angiotensin-converting enzyme inhibitors (ACEs) or angiotensin receptor blockers (ARBs). These medications are used primarily to treat high blood pressure.
Dr. Bakris and team's theory was that combining finerenone with these drugs would decrease albumin in the urine.
The patients on finerenone were found to have less albumin in their urine than patients on placebo after 90 days, with higher doses resulting in better outcomes.
Patients on 7.5 milligrams of finerenone a day had a 21 percent reduction in albumin, while patients on 20 milligrams a day had a 38 percent reduction.
Some patients developed high potassium levels, however.
In the 7.5 milligram group, 2.1 percent of patients had to stop taking finerenone because of high potassium. In the 20 milligram group, 1.7 percent of patients had to stop taking finerenone for the same reason.
This study was published Sept. 1 in the journal JAMA.
Bayer HealthCare AG (the company that makes finerenone) funded this research.
Several study authors disclosed ties to Bayer or other pharmaceutical companies that make drugs to treat diabetes or kidney failure.
Ruby Elizabeth Kassanoff, MD, FACP, is board certified in internal medicine on the medical staff of Baylor University Medical Center at Dallas. Dr. Kassanoff is interested in preventive care, health and wellness and also manages a wide range of medical conditions including diabetes, hypertension, thyroid problems and high cholesterol.