登录  注册

糖尿病及内分泌病学学术中心

FDA批准Jardiance用于降低2型糖尿病成人患者心血管死亡

FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes

发布者:FDA 发布时间:2016-12-14

The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.

美国FDA今日(2016年12月2日)批准了Jardiance(依帕列净)一项新的适应症,用于降低2型糖尿病和心血管疾病成人患者心血管死亡风险。

“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”

FDA药品评价与研究中心代谢与内分泌产品部主任Jean-Marc Guettier博士指出:心血管疾病是2型糖尿病成人患者死亡的主要原因。利用这些降低心血管死亡风险、有助于人们延长寿命的抗糖尿病药物,这对于2型糖尿病成人患者来说是重大进步。

According to the Centers for Disease Control and Prevention, death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.

根据美国疾病控制与预防中心数据,糖尿病成人患者心血管疾病死亡率比未患糖尿病人群高70%,糖尿病患者寿命预期降低,在很大程度上与过早心血管死亡有关。

The FDA’s decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.

FDA于2014年批准Jardiance作为饮食和锻炼的辅助用药,用于改善2型糖尿病成人患者的血糖控制。此次FDA的批准决定,是基于该机构要求开展的一项上市后研究结果。在一项由7,000多例2型糖尿病和心血管疾病患者参加的上市后临床试验中,对Jardiance进行了研究。在这项试验中,Jardiance作为糖尿病和动脉粥样硬化心血管疾病标准治疗的添加治疗,与安慰剂相比,可降低心血管死亡风险。

Jardiance can cause dehydration and low blood pressure (hypotension). Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose (hypoglycemia) when used with insulin or insulin secretagogues (e.g. sulfonylurea, a medication used to treat type 2 diabetes by increasing the release of insulin in the pancreas), vaginal yeast infections and yeast infections of the penis (genital mycotic infections), and increased cholesterol.

Jardiance可导致脱水和低血压。Jardiance还可造成血液酮体升高(酮症酸中毒)、严重尿路感染、急性肾损伤与肾功能损伤、与胰岛素或胰岛素促分泌剂(例如增加胰腺分泌胰岛素的2型糖尿病药物磺酰脲类)联合用药时可导致低血糖、阴道酵母菌感染与阴茎酵母菌感染(生殖器真菌感染)以及胆固醇升高。

The most common side effects of Jardiance are urinary tract infections and female genital infections.

Jardiance最常见副作用是尿路感染和女性生殖器感染。

Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Jardiance is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.

Jardiance不适用于1型糖尿病患者或糖尿病酮症酸中毒的治疗。Jardiance禁用于对Jardiance有严重过敏反应史、严重肾损伤、终末期肾病或透析患者。

Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

Jardiance由位于康涅狄格州利奇菲尔德的勃林格殷格翰制药公司销售。

未经同意禁止转载

顶一下(1
来源: FDA

发表评论

学科影响因子排名more

 会议回顾 more

  • 【专题】第75届美国糖尿病协会科学...

  • 【专题】2015年第24届美国临床...

  • 美国糖尿病学会(ADA)2013年...

 热门病例 more

 热门指南  more

Elsevier中国网站
爱唯医学网
爱思唯尔科技部
NursingChina
柳叶刀中文版
大通医疗决策
医大爱思唯尔
Elsevier医学数据库
CK
Journal Consult
Procedures_CONSULT
ClinicalPharmacologyLogo
3D Interact Anatomy
Mosby’s Nursing Consult
NursingChina
Science Direct