Lilly launches two prognostic studies to investigate hypoglycemic agents
Lilly launches two prognostic studies to investigate hypoglycemic agents
April 26, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The Boehringer Ingelheim-Lilly Diabetes Alliance recently announced plans to conduct two prognostic studies to investigate the therapeutic benefits of the hypoglycemic drug Jardiance (empagliflozin, englitavir) in patients with chronic heart failure. The two studies will be launched within the next 12 months and are planned to recruit patients with chronic heart failure with and without type 2 diabetes (T2D).
According to a statement issued by both parties, Jardiance was the first hypoglycemic agent to be confirmed in the cardiovascular (CV) endpoint test to significantly reduce the risk of cardiovascular death. Landmark cardiovascular (CV) prognostic clinical study EMPA-REG 0UTCOME shows placebo + standard care (including hypoglycemic agents and CV in adult patients with type 2 diabetes with high-risk cardiovascular (CV) events Compared with drugs, Jardiance+ standard care significantly reduced the risk of cardiovascular death by 38%, while reducing all-cause mortality by 32% and heart failure by 35%.
Based on these data, the two sides plan to launch two prognostic studies specifically to investigate the therapeutic benefits of Jardiance in patients with chronic heart failure. It is estimated that patients with heart failure have a mortality rate of up to 50% within 5 years of diagnosis, so there is an urgent need for effective treatments in this area. Heart failure is very common in people with diabetes, but in heart failure, about two-thirds of patients are not associated with diabetes.
EMPA-REG OUTCOME study:
The EMPA-REG OUTCOME clinical trial is a long-term, multicenter, randomized, double-blind, placebo-controlled study involving more than 7,000 patients with type 2 diabetes with high-risk cardiovascular (CV) events in 42 countries. The study evaluated the efficacy and safety of standard care combined with placebo when Jardiance (10 mg or 25 mg once daily) was added to standard care. Standard care in this study included hypoglycemic agents and cardiovascular drugs (including antihypertensives and lipid-lowering drugs). The primary endpoint was distance from first-onset cardiovascular (CV) death, nonfatal myocardial infarction, or nonfatal stroke. time.
The study data showed that Jardiance treatment significantly reduced the risk of cardiovascular (CV) death, nonfatal myocardial infarction, and nonfatal stroke in patients with type 2 diabetes by an average of 14 years compared with placebo. Among them, the risk of cardiovascular (CV) death was significantly reduced by 38%, and there was no significant difference in the risk of nonfatal myocardial infarction and non-fatal stroke. In addition, Jardiance treatment also significantly reduced all-cause mortality by 32% and heart failure hospitalization by 35%. In the study, the overall safety of Jardiance was consistent with previous clinical trials.
Jardiance: the world's first hypoglycemic agent to reduce cardiovascular risk
Jardiance is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. Emerging SGLT-2 inhibitors have been shown to block glucose reabsorption in the kidneys, excreting excess glucose into the body, thereby reducing blood sugar levels, and the hypoglycemic effect is independent of beta Cell function and insulin resistance.
In the United States, Jardiance was approved by the FDA in August 2014 for assisted diet and exercise to improve glycemic control in patients with type 2 diabetes. Jardiance is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis.
Diabetes increases the risk of heart disease, stroke and other diseases, and cardiovascular complications can also significantly affect the health and life expectancy of diabetic patients. It is estimated that approximately 50% of deaths from type 2 diabetes worldwide are caused by cardiovascular disease. Therefore, diabetes treatment drugs have been placed in the hope of reducing the risk of cardiovascular complications in patients.
At the end of January this year, the FDA accepted Jardiance's Supplemental New Drug Application (sNDA), which is based on the positive data of Jardiance's cardiovascular risk reduction in the milestone EMPA-REG 0UTCOME clinical trial. If approved, Jardiance will be the first hypoglycemic drug on the market to reduce the risk of heart disease, stroke and cardiovascular disease in patients with type 2 diabetes.
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