Boehringer Ingelheim and Eli Lilly have announced new clinical data from Jardiance (empagliflozin), showing it significantly reduces the risk of kidney disease progression in type 2 diabetes patients with established cardiovascular disease.
The findings were presented at the American Diabetes Association (ADA) 76th Scientific Sessions June 10-14 in New Orleans, and published in the New England Journal of Medicine in a study titled “Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.”
“These findings are clinically important, given that more than a third of people with type 2 diabetes will develop kidney disease, which can lead to kidney failure and eventually the need for dialysis. In the United States, the cost to treat chronic kidney disease is estimated to exceed $48 billion annually,” Christoph Wanner, M.D., chief of the Division of Nephrology and Hypertension at the University Hospital of Würzburg, Germany, said in a press release. “Since diabetes is the number one cause of kidney failure in the U.S., novel treatments that may have the potential to help address this crucial medical need are necessary.”
The results were part of the EMPA-REG OUTCOME trial, a randomized, double-blind, placebo-controlled, long-term study designed to assess cardiovascular outcomes in type 2 diabetes treated with Jardiance versus a placebo. Now, researchers have focused on the effects of Jardiance on the onset or progression of kidney disease.
Jardiance is a selective SGLT2 inhibitor that reduces blood glucose levels by reducing the reabsortion of glucose in the kidney and thus increasing glucose excretion.
The team of researchers examined the outcomes of 7,020 patients with type 2 diabetes and established heart disease from 42 different countries who had taken Jardiance versus a placebo, and revealed that patients who received Jardiance had a a 55 percent reduction in the initiation of renal replacement therapies, such as dialysis; had a significant reduction in the levels of creatinine, a waste product that is filtered by the kidneys; and showed a decreased risk of exhibiting high levels of albumin in the urine.
Such outcomes were accompanied by a slowed progression in kidney function decline over time in patients receiving Jardiance, compared to those in the placebo group, even when these patients were already receiving standard of care therapies for kidney disease in type 2 diabetes.
“With these new EMPA-REG OUTCOME data, Jardiance is the only SGLT2 inhibitor associated with evidence of slowing the progression of kidney disease in adults with type 2 diabetes and established cardiovascular disease in a cardiovascular outcome study,” said Prof. Hans-Juergen Woerle, global vice president medicine at Boehringer Ingelheim.