INGELHEIM, Germany & INDIANAPOLIS, US - Tuesday, June 14th 2016 [ME NewsWire]
Jardiance® (empagliflozin) is the only SGLT2 inhibitor to demonstrate the potential to improve kidney outcomes on top of standard of care
New data from the landmark EMPA-REG OUTCOME® clinical trial published in The New England Journal of Medicine
(BUSINESS WIRE)-- 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 (NYSE: LLY) announced today 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. 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. 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.
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. 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 kidney 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 Prof. Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim.
About the EMPA-REG OUTCOME® Trial
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, 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.
About Diabetes and Cardiovascular Disease
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. Type 2 diabetes is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. 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 type 2 diabetes worldwide are caused by CV disease.
About Diabetes and Kidney Disease
Kidney disease is much more common in people with diabetes than in those without diabetes, affecting about half of those with type 2 diabetes. In its final stages, kidney disease can lead to kidney failure, which typically necessitates either dialysis or a kidney transplant. Declining kidney function is associated with a lower than average life expectancy and also increases the risk of other diabetes-related complications such as hypoglycaemia and cardiovascular (CV) disease. Cardiovascular (CV) disease is the number one cause of death in people with type 2 diabetes.
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.
Jardiance® is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
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Boehringer Ingelheim GmbH
Dr Ralph Warsinsky
Executive Director Media & PR
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