Jardins® (empagliflozin) will be studied for the treatment of patients with chronic heart failure
The complete official instruction of the state register of medicines for the Jardins® trade medication is available in the TALKDRUGS medicinal guide here.
· New research will evaluate the effectiveness of the use of "Jardins®" in the treatment of chronic heart failure
· About 26 million people worldwide, of them 5.7 million in the US, suffer from chronic heart failure
· Planned studies are based on the results of the global project "EMPA-REG OUTCOME®"
Ingelheim, Germany, and Indianapolis, United States - The company "Behringer Ingelheim" and "Eli Lilly and Company" (NYSE:LLY) announced plans to conduct two studies of a remedy for diabetes "Jardins®" (empagliflozin), which will allow to determine its possibilities for treatment of patients with chronic heart failure. Studies are scheduled to begin within the next 12 months, it is expected that they will include patients with chronic heart failure both with type 2 diabetes mellitus (DM2) and without it.
"Jardins®" became the first oral hypoglycemic drug in the treatment of diabetes mellitus, which reduced the risk of cardiovascular (CC) mortality, which was proved in a special study. The drug demonstrated superiority over standard therapy (including hypoglycemic drugs and drugs for the treatment of CC diseases) in patients with high-cardiovascular risk of CD2.In addition to reducing MOP mortality by 38%, the study "EMPA-REG OUTCOME®"showed that "Jardins®" reduces the risk of hospitalization for heart failure by 35% in patients with diabetes with high cardiovascular risk. These results were the basis for planning new research.
"Research"EMPA-REG OUTCOME"showed that Jardins® reduces the risk of cardiovascular death in patients with diabetes and high cardiovascular risk, and now we are planning to explore whether Jardins® can be useful in treating heart failure, "says Professor Hans-Jurgen Wörle (Hans-Juergen Woerle), vice-president of medicine at the company Boehringer Ingelheim.
"Every second patient with heart failure dies within five years after confirming the diagnosis, so at present there is an urgent need for effective therapy to treat those who suffer from this ailment", - says Dr. Javed Butler (Javed Butler), a cardiologist from the hospital of the University of Stony Brook.
About heart failure
Heart failure is a condition where the heart can not pump enough blood through the body. This is a serious condition that can lead to death.Heart failure is a common disease - 26 million people worldwide, of which 5.7 million in the US suffer from chronic heart failure. In the US, a new case of heart failure is diagnosed every 35 seconds. There is a high unmet need for the treatment of heart failure, as this disease is common and characterized by a high mortality rate. Heart failure is widespread in patients with diabetes mellitus, nevertheless, about two-thirds of all patients with heart failure do not have a diagnosis of "diabetes."
About the preparation "Jardins®"
The drug "Jardins®"(empagliflozin) is an oral, highly selective inhibitor of the sodium-dependent glucose transporter of type 2 (SGLT2) with a frequency of once a day, approved for use in Europe, the US and many other countries around the world for the treatment of adult patients with type 2 diabetes mellitus.
"Jardins®"blocks the reabsorption of glucose by the kidneys, which contributes to the excretion of glucose in the urine and the reduction of blood glucose in patients with type 2 diabetes mellitus. SGLT2 is aimed directly at excretion of glucose and acts independently of the function of β-cells and insulin resistance.
"Jardins®"is not intended for patients with type 1 diabetes or for patients with diabetic ketoacidosis (elevated ketones in blood or urine).
About the study "EMPA-REG OUTCOME®"
"EMPA-REG OUTCOME®" is a long-term, multicenter, randomized, double-blind, placebo-controlled study in which more than 7,000 patients from 42 countries with type 2 diabetes and a high risk of cardiovascular events participated.
The study was designed to evaluate the effectiveness of the drug "Jardins®"(10 or 25 mg once daily, daily) in addition to standard therapy, compared with placebo in addition to standard therapy.Standard therapy included glucose-lowering drugs and drugs for the treatment of CVD (including antihypertensive drugs and drugs for lowering cholesterol.) The primary endpoint was defined as a combined endpoint, including cases of cardiovascular death, infarction myocardial infarction without a fatal outcome and stroke without a fatal outcome ..
On average, for a period of 3.1 years, "Jardins®" provided a statistically significant reduction in the risk of cardiovascular mortality, non-fatal myocardial infarction and a non-fatal stroke by 14% compared with placebo. The risk of cardiovascular mortality was reduced by 38%, without significant differences in the risk of myocardial infarction without a fatal outcome and a stroke without a fatal outcome. Treatment with "Jardins®"also led to a 32% reduction in the risk of total mortality 35% reduction in the risk of hospitalization for heart failure.
The general safety profile of the preparation "Jardins®" consistent with previous research. The frequency of diabetic ketoacidosis was not higher than 0.1% and similar in all treatment groups.