The drug finerenone has a positive effect on patients with type 1 diabetes and chronic kidney disease. The drug reduces the amount of proteins excreted in the urine of these patients. This reduction indicates that the degree of kidney damage is reduced and that the drug has a protective effect on kidney function.
Clinical pharmacologist Hiddo Lambers Heerspink of the UMCG led a large international study into the effect of this drug. He will present the initial results of this study at the American Society of Nephrology conference in Houston, where he will present the results during the plenary opening of the conference on 6 November.
First effective and safe drug in 30 years for patients with type 1 diabetes
Although many new drugs have been discovered in recent years for the treatment of kidney disease in patients with type 2 diabetes, this is not the case for patients with type 1 diabetes. This is mainly because patients with type 1 diabetes were often excluded from participating in studies due to possible side effects. As a result, kidney disease in people with type 1 diabetes is still treated with blood pressure-lowering drugs dating back to research conducted more than 30 years ago. Finerenone is now the first new drug in more than 30 years that is effective and safe for this patient group. It is expected that the drug can now be registered in the guidelines for the treatment of type 1 diabetes.
Best possible endpoint is protein loss in urine
Previous research by Hiddo Lambers Heerspink showed that protein loss in urine (albuminuria) is the best possible indicator of early, measurable kidney protection. The more traditional endpoint in clinical drug studies, such as the onset of dialysis and kidney transplantation, only become apparent at a late stage and require large, long-term studies.
Because there are far fewer patients with type 1 diabetes and kidney disease compared to type 2 diabetes and kidney disease, drug studies with traditional endpoints are practically impossible to conduct. That is why Hiddo Lambers Heerspink and his research team found an alternative and investigated the effect of the drug finerenone on protein excretion.
Positive effect of finerenone
In the study now being presented, Hiddo Lambers Heerspink investigated the effect of the drug finerenone, which blocks the receptor for the hormone aldosterone. Aldosterone is a hormone produced in the adrenal glands that regulates salt and water balance to maintain blood pressure. It had previously been shown that this drug had a positive effect in patients with type 2 diabetes in slowing down kidney function loss and protecting the heart.
In the study, Heerspink investigated whether the drug led to less protein in the urine and whether it was well tolerated in 242 patients with type 1 diabetes and chronic kidney disease. The patients were followed for six months and the amount of protein in their urine was found to have decreased by about a quarter. This is very likely to translate to less kidney failure in these patients. Finerenoen was also safe and well tolerated, except for a slightly elevated potassium level in the blood.
About this research
Eighty-two hospitals from nine countries in Asia, Europe and North America participated in the study. According to Hiddo Lambers Heerspink, the results of this study offer hope for patients with type 1 diabetes. At the same time, it encourages researchers to conduct more research into the effect of new medications in these patients at high risk of kidney and heart diseases.
About type 1 diabetes
Type 1 diabetes is an autoimmune disease in which there is a shortage of insulin and blood sugar levels rise. It is estimated that nearly 9 million people worldwide live with type 1 diabetes. In the United Kingdom, there are more than 100,000 people with this disease.
A common and serious complication of type 1 diabetes is chronic kidney disease (CKD), which affects 30 to 40 percent of patients. This group also has an increased risk of kidney failure and cardiovascular disease. Research shows that in more than a third of patients, kidney failure develops within 15 years of the onset of severe protein loss through the urine (albuminuria).
The current treatment of type 1 diabetes with kidney disease focuses primarily on lifestyle improvement, blood sugar regulation and blood pressure control, usually with RAS inhibitors. However, new drugs to slow the loss of kidney function have been lacking for decades. This is worrying, as mortality and morbidity in this group remain high.
