FDA批准empagliflozin治疗成年人2型糖尿病

基于7项研究近4500例患者的数据，美国食品药品管理局已批准每日1次口服的empagliflozin用于治疗成年人们2型糖尿病。

Empagliflozin是一种钠糖共转运蛋白2（SGLT2）抑制剂，可阻断肾脏对葡萄糖的重吸收，增加葡萄糖排泄，降低血糖水平。研究者已观察了该药单用和及联合其他抗2型糖尿病药物（包括二甲双胍、磺酰脲类、吡格列酮及胰岛素）的治疗效果。

该药的最常见副作用是生殖系统感染（女性）和泌尿道感染。该药治疗还可引起脱水及低血压，伴惊厥和/或虚弱，以及肾功能下降。“老年患者、肾功能受损患者以及因其他疾病服用利尿剂的患者，似乎更可能发生上述副作用。”

勃林格殷格翰制药公司将以Jardiance的商品名销售empagliflozin。

这是第三种在美国获准上市的SGLT2抑制剂，之前获准的两种SGLT2分别是2014年1月获准的dapagliflozin（Farxiga）和2013年3月获准的canagliflozin（Invokana）。

Empagliflozin不可用于治疗严重肾功能受损、终末期肾病或正在接受透析的患者，也不可用于患有糖尿病酮症酸中毒和1型糖尿病的患者。

勃林格殷格翰必须开展四项上市后研究：一项心血管结局试验（已在进行中），一项小儿药理学研究，一项小儿安全性和有效性研究（将包括对骨骼健康和发育的评估），以及一项青春期动物毒理研究。其中这项动物研究将专门观察肾脏发育、骨骼发育及生长。

今年5月，欧盟已批准empagliflozin治疗组成年人2型糖尿病。

爱思唯尔版权所有  未经授权请勿转载

By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

AUGUST 1, 2014

The Food and Drug Administration has approved once-daily oral empagliflozin for adults with type 2 diabetes, based on seven studies with nearly 4,500 patients.

Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. It has been studied "as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin," according to an Aug. 1 FDA statement announcing the approval.

Boehringer Ingelheim Pharmaceuticals will market empagliflozin asJardiance.

This is the third SGLT2 inhibitor approved by the FDA, following the approval of dapagliflozin (Farxiga) in January 2014 and canagliflozin (Invokana) in March 2013.

The most common side effects of treatment are genital infections in women and urinary tract infections, according to the FDA. Treatment can also cause dehydration resulting in hypotension, with dizziness and/or fainting, as well as reduced renal function. "The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk," the FDA noted.

Empagliflozin should not be used to treat patients with severe renal impairment or end-stage renal disease, or who are on dialysis. The drug also should not be used in patients with diabetic ketoacidosis and those with type 1 diabetes.

Boehringer Ingelheim must conduct four postmarketing studies of empagliflozin: a cardiovascular outcomes trial, which is already underway; a pediatric pharmacokinetic/pharmacodynamic study; a pediatric safety and efficacy study (which will include evaluations of bone health and development); and a juvenile animal toxicity study. The animal study will have "a particular focus on renal development, bone development, and growth," the FDA statement said.

In May, the European Commission approved empagliflozin for treating adults with type 2 diabetes.