Health
Investigative drug benefits patients with chronic kidney disease and type 2 diabetes
Findings that were simultaneously published in the New England Journal of Medicine and presented at the American Society of Nephrology’ Kidney Week 2020 Conference show that the investigational drug Finelenone provides specific renal and cardiovascular benefits to patients with chronic kidney disease and type 2 diabetes. It shows that it has been brought.
The 5,700 Phase III trial was led by Dr. George Bakris, MD, Professor of Medicine at the University of Chicago and Director of the Center for Hypertension at the University of Chicago School of Medicine. The study, conducted in more than 1,000 locations in 48 countries, was the largest ever research effort on the disease, affecting millions in the United States alone. Over a quarter of adults with diabetes eventually develop chronic kidney disease, and diabetes is the leading cause of renal failure.
Physicians can now safely slow the progression of diabetic nephropathy and reduce the incidence of cardiovascular events with a new non-steroidal mineralocorticoid receptor blocker, finelenone, which has not yet been approved by the FDA. There is evidence that it can be done. This is very important for groups of patients who have historically had few options. This promising goal of the new treatment means that patients can delay dialysis and thus further delay the need for kidney transplants. Reducing cardiovascular events is an additional bonus to slow the progression of kidney disease. “
Dr. George Bakris, Professor of Medicine, University of Chicago, Director, Center for Hypertension, University of Chicago
Manufactured by Bayer, finelenone is a non-steroidal selective mineralocorticoid receptor (MR) antagonist. The use of this drug has not yet been approved, but it is being investigated in many clinical trials, including FIGARO, which will end next year for cardiovascular outcomes. It directly targets and blocks receptors that contribute to inflammation and scarring of the heart and kidneys. The kidneys also filter waste and water from the body and control blood pressure. Damage to the kidneys can lead to backup of waste products and fluids in the body.
The study, called FIDELIO-DKD, a finelenone that reduces kidney disease and disease progression in diabetic kidney disease, shows that the drug is significantly superior to placebo and has a median of 2.6 compared to current standards. Of care that has been shown to slow the progression of kidney disease by 18% in years.
Patients receiving finelenone reported high levels of potassium (18% vs. 9% in placebo), but serious potassium-related side effects requiring discontinuation of the study were rare, compared to 2.8% of patients. It occurred in 0.9% of the group.High levels of potassium can cause rhythm problems
Earlier this year, Bayer announced that the trial met its complex primary renal endpoint and its complex primary secondary cardiovascular endpoint. However, the full results of the trial were not announced until October 23. The trial was randomized, double-blind, placebo-controlled.
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