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FDA approves Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes!
2017-03-10
来源:转载自第三方
10 March 2017
Recently, a new compound drug Qtern (dapagliflozin 10mg + saxagliptin 5mg) for treatment of type 2 diabetes from AstraZeneca obtained approval of FDA. The drug is a fixed dose of compound monolithic for adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.
Diabetes is a complex chronic lifelong disease, the trend is growing. The latest data from International Diabetes Federation (IDF) show that in 2014 there were 387 million people with diabetes around the world, of which, type 2 diabetes accounted for 85% to 95% in high-income countries. At present, more than 450 million people worldwide suffer from diabetes, and it is estimated that by 2035, the number of diabetic patients will increase by 55% to 600 million.
The treatment for diabetes is a long-term integrated management process and need continuous adjustment according to the course of desease. It should combine drugs, diet, exercise and mentality treatment together. The necessary hypoglycemic drugs is essential. The compound medicine uses the complementary synergies of the main drug to achieve the purpose of lowering blood sugar, taking less dose, the success rate is higher, and has little side effects. And it can enhance the hypoglycemic effect of diabetes drugs.
The two compound components of Qtern both have new complementary hypoglycemic mechanism:
- Dapagliflozin—SGLT-2 inhibitors, it can inhibit the reabsorption of glucose in kidney, so that excess glucose is drained from the urine, directly lower blood sugar. The current SGLT-2 inhibitors on global market are: Canagliflozin, Dapagliflozin, Empagliflozin, Ipragliflozin, Luseogliflozin and Tofogliflozin;
- Saxagliptin—DPP-4 inhibitors, it inhibits the function of hydrolyzed proteins of DDP-4, so that GLP-1 will not be decomposed. GLP-1 can stimulate insulin, inhibit glycogen, inhibit gastric emptying and rebirth Islet cells to lower blood sugar. At present, there are 5 drugs are most studied and has been applied to clinical practice, they are Sitagliptin, Vildagliptin (intermediate 3-amino-1-1-Adamantanol), Saxagliptin, Alogliptin and linagliptin.
In the Phase 3 clinical study, data from a 24-week, multi-centre, randomised, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type-2 diabetes who experienced inadequate glycaemic control with metformin has been collected. It can effectively help improve blood sugar only need once a day with oral diet.
AstraZeneca aims to develop life-changing drugs that reduce the global burden and complications of diabetes. It continues to deepen the exploration of diabetes in the majority of patients, to explore the combination of products to help more patients to achieve successful treatment in the early development of disease. The Qtern provides a convenient new choice for type 2 diabetes patients to improve blood sugar control.
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.
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