The world's first hypoglycemic drug, Jardiance, which reduces the risk of cardiovascular death, is approved by the US FDA December 08, 2016 Source: Bio Valley Jardiance (empagliflozin, Englelie), a hypoglycemic drug developed by the Boehringer Ingelheim-Lilly Diabetes Alliance, has recently received great news in US regulation! The US Food and Drug Administration (FDA) has approved Jardiance for adult patients with type 2 diabetes (T2D) who are suffering from cardiovascular disease, reducing the risk of cardiovascular death. This approval has made Jardiance the first and only approved diabetes drug worldwide to reduce the risk of cardiovascular death in patients with type 2 diabetes. It is currently known that 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; in the United States, this proportion is as high as two-thirds. Therefore, there is an urgent need in the field for a diabetes drug that can effectively reduce this complication. The approval of the new Jardiance indications marks a major milestone in the clinical treatment of patients with type 2 diabetes mellitus with cardiovascular disease. The approval of the new indication for Jardiance is based on positive data from the landmark clinical study (EMPA-REG OUTCOME). The study was 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 significantly reduced cardiovascular (CV) death, nonfatal myocardial infarction, and nonfatal stroke risk by 14% in patients with type 2 diabetes over an average of 3.1 years. 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 also significantly reduced all-cause mortality by 32% and heart rate hospitalization by 35%. In the study, the overall safety of Jardiance was consistent with previous clinical trials. Jardiance (empagliflozin, nglipepsin) 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.
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