INGELHEIM, Germany & INDIANAPOLIS, US - Tuesday, April 19th 2016 [ME NewsWire]
- New studies will evaluate the effect of Jardiance® for the treatment of chronic heart failure
- There are approximately 26 million people worldwide, and 5.7 million people in the U.S., suffering from chronic heart failure
- The studies build on results from the landmark EMPA-REG OUTCOME® trial
(BUSINESS WIRE)-- Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced plans to conduct two outcome trials investigating the diabetes medicine Jardiance® (empagliflozin) for the treatment of people with chronic heart failure. The trials are targeted to begin within the next 12 months and are planned to enrol people with chronic heart failure both with and without type 2 diabetes (T2D).
Jardiance® was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. This was demonstrated on top of standard of care (including glucose-lowering agents and CV drugs) in people with T2D at high risk of CV events. In addition to reducing CV death by 38 percent, the EMPA-REG OUTCOME® trial also showed that Jardiance® reduced the risk of hospitalisation for heart failure in people with T2D at high risk of CV events by 35 percent. These results led to the planned trials.
“The EMPA-REG OUTCOME trial demonstrated that Jardiance reduces the risk of cardiovascular death in diabetes patients at high cardiovascular risk, and we now look forward to exploring whether Jardiance can also provide heart failure benefits,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim.
“One in two people with heart failure die within five years of diagnosis, so there is currently a compelling need for an effective therapy to treat those suffering from this condition,” said Dr Javed Butler, cardiologist, Stony Brook University Hospital.
About heart failure
Heart failure is when the heart cannot pump enough blood around the body. It is a debilitating condition and can be fatal. Heart failure is a prevalent disease; 26 million people around the world and 5.7 million people in the United States have chronic heart failure. Every 35 seconds a new case of heart failure is diagnosed in the United States. There is a high unmet need in the treatment of heart failure as there is significant morbidity and mortality associated with the condition. Heart failure is highly prevalent in patients with diabetes, however, approximately two-thirds of all heart failure patients do not have diabetes.
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose cotransporter 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).
About EMPA-REG OUTCOME®
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 at high risk for cardiovascular events.
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 cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.
Over a median of 3.1 years, Jardiance® significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of cardiovascular death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. Treatment with Jardiance® also resulted in a 32 percent reduced risk of all-cause mortality and a 35 percent reduced risk of hospitalisation for heart failure.
The overall safety profile of Jardiance® was consistent with that of previous trials. The incidence of diabetic ketoacidosis was at or below 0.1 percent and similar across all treatment groups.
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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