New data showed Jardiance (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 percent versus placebo when added to standard of care in people with type 2 diabetes with established cardiovascular disease. Boehringer Ingelheim and Eli Lilly and Company announced that the findings have been published in The New England Journal of Medicine and also presented at the American Diabetes Association (ADA) 76th Scientific Sessions in New Orleans.
"These findings are clinically important, given that one in two people with type 2 diabetes worldwide will develop kidney disease, which can lead to kidney failure and eventually the need for dialysis." said Prof Christoph Wanner, Chief of the Division of Nephrology and Hypertension at the University Hospital of Würzburg, Germany. "Since diabetes is the number one reason people require dialysis treatment, novel treatments that may have the potential to help address this crucial medical need are necessary."
These findings were part of a pre-specified exploratory analysis plan of additional endpoints of the landmark EMPA-REG OUTCOME trial.1 New-onset or worsening kidney disease was a pre-specified composite endpoint that included the below clinical events. Compared with placebo, Jardiance led to the following statistically significant changes in outcomes:
55 percent reduction in the initiation of kidney replacement therapy (such as dialysis)
44 percent reduction in doubling of creatinine (a waste product usually filtered by the kidneys) in the blood
38 percent reduction in progression to macroalbuminuria (very high levels of a protein called albumin in the urine)
Jardiance also significantly slowed the decline in kidney function over time compared with placebo.1 Most patients in this trial were already taking the recommended standard treatment for kidney disease in type 2 diabetes, renin angiotensin aldosterone system blockade; the kidney effects of Jardiance® were apparent on top of these agents.1
Consistent risk reductions in kidney outcomes with Jardiance® were seen in people who had impaired kidney function, or increased levels of albumin in the urine, at baseline and in those who did not, according to a post hoc sub-group analysis.1 Serious adverse events (AEs) and AEs leading to treatment discontinuation for Jardiance versus placebo were comparable for those with or without impaired kidney function at baseline.1 Death due to kidney disease was rare and occurred in three patients treated with Jardiance (0.1 percent) and none treated with placebo.