2018年12月23日,日本药企安斯泰来(Astellas)和日本寿制药公司(Kotobuki Pharmaceutical)近日联合宣布,Suglat(ipragliflozin L-proline,伊格列净L-脯氨酸)用于治疗1型糖尿病的额外适应症以及额外的剂量和给药方案已获得日本监管机构批准。在日本市场,Suglat于2014年1月获批2型糖尿病适应症,并于2014年4月开始销售。
Suglat是通过安斯泰来与寿制药的一项研究合作发现的一种选择钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂。SGLT是一类膜蛋白,存在于细胞表面,能够将葡萄糖转运至细胞内。SGLT有2种亚型,即SGLT1和SGLT2,分别分布于小肠粘膜和肾小管。SGLT2在近端肾小管葡萄糖再吸收中发挥着关键作用。 Suglat通过选择性抑制SGLT2,使肾小管中的葡萄糖不能顺利重吸收进入血液而随尿液排出,从而降低血糖浓度。
1型糖尿病是一种胰岛素缺乏性疾病,当胰腺中分泌胰岛素的β细胞被免疫系统破坏时发生。据估计,在日本大约有1000万人可能患有糖尿病,其中1型糖尿病约占6%。Suglat将为采用胰岛素治疗血糖控制不足的1型糖尿病患者提供一种新的治疗方案。
值得一提的,安斯泰来并非涉足SGLT抑制剂治疗1型糖尿病领域的唯一玩家。目前,阿斯利康降糖药Farxiga(安达唐,通用名:dapagliflozin,达格列净)和赛诺菲降糖药Zynquista(sotagliflozin,索格列净)治疗1型糖尿病也已进入监管审查,前者是一款SGLT2抑制剂,后者是一款SGLT-1/SGLT-2双效抑制剂。
Suglat Tablets 50mg
Description
This medicine inhibits SGLT2 which resorbs glucose in the kidney, thus reducing blood glucose through the excretion of excess glucose into urine.
It is usually used for the treatment of type 2 diabetes.
Presentation
Feature
Active Ingredients
Ipragliflozin L-Proline
Effect/Efficacy
Usage/Dosage
In general, for adults, take 1 tablet (50 mg of ipragliflozin) at a time, once a day before or after breakfast. If the effect of this medicine is insufficient, it may be increased up to 2 tablets (100 mg) once a day while carefully following the course of the disease. If you have a severe hepatic impairment, the dosage may be started with low doses. Strictly follow the instructions.
If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Cautions
Strictly follow the instructions on dietary/exercise therapy.
This medicine may cause hypoglycemic symptoms. Be aware of operating in potentially hazardous activities such as driving a car and working at heights.
Take foods containing sugar or drink juice if any hypoglycemic symptoms occur. If you are taking in conjunction with α-glucosidase inhibitors (medicines which delay the uptake of glucose) and hypoglycemic symptoms develop, you must take in glucose.
Take a larger amount of water, since this medicine may cause dehydration. Intake of water or tea is desirable, since drink including sugar such as isotonic drink may increase blood glucose.
Do not stop taking water or decrease the amount of water on your own judgment.
Stop taking the medicine if you have repeated diarrhea/vomiting or cannot take food or water continuously due to decreased appetite.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include urinary frequency, thirst, constipation, and weight loss. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
light headedness, lassitude, sweating, hunger, shaking of hands and feet [hypoglycemia]
chills, fever, flank pain, back pain, lower back pain [pyelonephritis]
Thirst/dry mouth, large urinary volume, dizziness/lightheadedness [dehydration]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
原文出处:Approval of Suglat® Tablets, Selective SGLT2 Inhibitor, for Additional Indication of type 1 diabetes mellitus and Additional dosage and administration in Japan