New data showed Jardiance (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 per cent versus placebo when added to standard of care in adults 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 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," said Christoph Wanner, M.D., chief of the Division of Nephrology and Hypertension at the University Hospital of Würzburg, Germany. "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."
These findings were part of a pre-specified exploratory analysis plan of additional endpoints of the landmark EMPA-REG OUTCOME trial. 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 renal 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. 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 renal effects of Jardiance were apparent on top of these agents.
Consistent risk reductions in kidney outcomes with Jardiance were seen in adults 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. 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. Death due to renal disease was rare and occurred in three patients treated with Jardiance (0.1 percent) and none treated with placebo.
"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 Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim.
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular (CV) disease.
The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Over a median of 3.1 years, Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
The overall safety profile of Jardiance in the EMPA-REG OUTCOME trial was consistent with that of previous trials.
Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 per cent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the US, approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes (T2D) is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the US. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular (CV) disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop CV disease than people without diabetes. In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause. Approximately 50 percent of deaths in people with T2D worldwide are caused by CV disease. In the US, health care costs for managing cardiovascular conditions in patients with diabetes totalled more than $23 billion dollars in 2012.
Kidney disease develops in approximately 35 percent of patients with type 2 diabetes (T2D) and is associated with increased risk of death. Long-term kidney problems, known as chronic kidney disease, can lead to kidney failure in its final stages and typically necessitates either dialysis or a kidney transplant. Nearly 44 percent of new cases of kidney failure are due to diabetes, and up to 40 percent of people with T2D in the US will eventually suffer from kidney failure.