Medical Network September 29th, September 27, Boehringer Ingelheim-Lilly Diabetes Alliance announced a new generation of oral sodium-glucose co-transporter 2 (SGLT2) inhibitors - Ou Tangjing® (common name: En Gleconet has been approved by the State Food and Drug Administration for listing in mainland China. It can be used alone or in combination with metformin or metformin and sulfonylureas to improve glycemic control in patients with type 2 diabetes.
Ou Tangjing® is a highly selective SGLT2 inhibitor with a unique insulin-independent hypoglycemic pathway that directly releases sugar from the urine by reducing glucose reabsorption in the kidneys. In addition to a clear hypoglycemic effect, it can also bring additional benefits to lose weight, lower blood pressure, and reduce uric acid. Ou Tangjing® is safe and can reduce the risk of cardiovascular events and progression of kidney disease in diabetic patients. It is the world's first type 2 diabetes drug that has been shown to reduce cardiovascular risk by large-scale cardiovascular outcome study (EMPA-REG OUTCOME®). .
The risk of dying from cardiovascular disease in diabetics is twice that of people without diabetes [1]. Worldwide, approximately one in every two diabetic patients die from cardiovascular disease. Cardiovascular complications have become the biggest threat to patients with type 2 diabetes. Up to 80% of patients with diabetes have a high risk of cardiovascular and cerebrovascular disease, that is, 4 out of every 5 patients with type 2 diabetes have a high risk of cardiovascular and cerebrovascular disease.
EMPA-REG OUTCOME® is a long-term, multicenter, randomized, double-blind, placebo-controlled clinical trial. The study included 7020 patients with type 2 diabetes in 42 countries, with an average of 3.1 years of experience, to assess the addition of engrelium (10 mg or 25 mg once daily) or placebo to standard treatment. effect. The results showed that the use of the SGLT-2 inhibitor, englitavir, in patients with type 2 diabetes with cardiovascular disease significantly reduced the incidence of major composite cardiovascular endpoints and all-cause mortality compared with placebo. For patients with type 2 diabetes who are at high risk for cardiovascular disease, engelivir reduces all-cause mortality by 32%, cardiovascular mortality by 38%, and 35% of heart failure hospitalization.
Based on the results of this study, the US FDA approved in December 2016 an indication for the reduction of cardiovascular disease death risk in adults with type 2 diabetes and cardiovascular disease in December 2016. Subsequently, the European Commission also approved in January 2017 that Engleet was indicated in the instructions as having dual utility* for controlling blood sugar and reducing the risk of cardiovascular death*. (Note: Ou Tangjing® approved indications in China do not include a reduction in the risk of cardiovascular death.) The latest post-mortem analysis of EMPA-REG OUTCOME® was announced at the annual meeting of the European Association for Diabetes Research in September this year, showing Engel Lexington® reduces the risk of cardiovascular death independent of background glycemic control.
Among diabetic patients, kidney disease is more common and may lead to kidney failure, requiring dialysis or kidney transplantation. [2] About half of patients with type 2 diabetes have a certain degree of kidney disease [3]. Kidney disease can increase the risk of cardiovascular disease by up to 4 times [4] [5].
The kidney results of EMPA-REG OUTCOME® show that nggliflozin has good kidney safety: nggliflozin can reduce the risk of new nephropathy or nephropathy by 39%, reduce the risk of progression to a large amount of proteinuria by 38%, and reduce creatinine levels. The risk of doubling is 44% and the risk of starting renal replacement therapy is reduced by 55%.
Ou Tangjing® has been listed in more than 80 countries around the world and is generally safe. Ou Tangjing® is available in China in a dosage form of 10 mg, which is administered once daily.
[1] Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.
[2] International Diabetes Federation. The Kidney. p.15.
[3] Thomas MC. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. National Review of Nephrology. 2016;12(2):73-81.
[4] Gansevoort RT, et al. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. The Lancet. 2013;382:339-52.
[5] Bays H. From victim to ally: the kidney as an emerging target for the treatment of diabetes mellitus. Curr Med Res Opin. 2009;25(3):671-81
