2型糖尿病Jardiance(empagliflozin)片再获美国FDA批准一个增加新适应证将成为目前唯一被证实可降低心血管风险的降糖药
FDA的药品评价和研究中心的代谢和内分泌产品部主任Jean-Marc Guettier，M.D.，C.M. 说：“在有2型糖尿病成年中心血管病是死亡主要原因。” “抗糖尿病治疗的可供利用性可能有助于通过减低心血管死亡的风险而活的更长对有2型糖尿病成年是重要进展。”
批准日期：2016年12月1日：公司：Boehringer Ingelheim Pharmaceuticals，Inc.
JARDIANCE®(empagliflozin)片，为口服使用
美国初次批准：2014
最近重大改变
适应证和用途 12/2016
警告和注意事项 12/2016
作用机制
钠-葡萄糖共转运蛋白2(SGLT2)是占优势转运蛋白负责葡萄糖从肾小球过滤再吸收返回循环。Empagliflozin是SGLT2的抑制剂。通过抑制SGLT2，empagliflozin减低滤过的葡萄糖的肾再吸收和降低葡萄糖的肾阈，和因此增加尿葡萄糖的排泄。
适应证和用途
JARDIANCE是一种钠-葡萄糖共转运蛋白2(SGLT2)抑制剂适用于：
●在有2型糖尿病成年中作为辅助饮食和运动改善血糖控制。
● 在有2型糖尿病和确定的心血管疾病成年患者中减低心血管死亡风险。
使用的限制：
● 不为1型糖尿病或酮症酸中毒的治疗
剂量和给药方法
● JARDIANCE的推荐剂量是10mg每天1次，在早晨服用，有或无食物
●剂量可增至25mg每天1次
●开始JARDIANCE前评估肾功能。如eGFR低于45mL/min/1.73m2不要开始JARDIANCE
●如eGFR持久地下降低于45mL/min/1.73m2终止JARDIANCE
剂型和规格
片：10mg，25mg
禁忌证
●对JARDIANCE严重超敏反应史
● 严重肾受损，终末肾病，或透析
警告和注意事项
●低血压：在有肾受损患者中，老年人，在有低收缩血压患者中，和在用利尿药患者中JARDIANCE开始前评估和纠正容积状态。
●酮症酸中毒: 对酮症酸中毒不管血葡萄糖水平评估患者存在有代谢性酸中毒的体征和症状。 如怀疑，终止 JARDIANCE，评价和及时治疗。开始JARDIANCE前，考虑对酮症酸中毒风险因子。患者用JARDIANCE可能需要监视和暂时终止治疗在临床情况已知易于酮症酸中毒。
●急性肾损伤和肾功能中有损: 考虑暂时性终止在情况减低经口摄取或液体丢失。如发生急性肾损伤，终止和及时治疗。治疗期间监视肾功能。
●尿毒症和肾盂肾炎: 评价患者尿道感染的体征和症状和如适当及时治疗。
● 低血糖：考虑降低胰岛素促分泌剂或胰岛素的剂量以减低当开始JARDIANCE低血糖的风险
● 生殖器霉菌感染：如适当时监视和治疗
●泌尿道感染：如适当时监视和治疗
●增加的LDL-C：如适当时监视和治疗
不良反应
● 伴随JARDIANCE最常见不良反应(5%或更大发生率)为尿道感染和女性生殖器霉菌感染。
报告怀疑不良反应，联系Boehringer Ingelheim Pharmaceuticals，Inc.
在特殊人群中使用
● 妊娠：劝告对一个胎儿特别地45mL/min/1.73m2第二和第三个三个月期间潜在风险女性
● 哺乳母亲：当哺乳时建议不用JARDIANCE
● 老年患者：相关容积耗损和肾功能减低的不良反应的较高发生率。
●有肾受损患者中：肾功能减低相关不良反应的较高发生率。
供应/贮存和处置
JARDIANCE片可得到10mg和25mg两种规格如下：
10 mg片：淡黄色，圆，双凸和斜边，膜包衣片在一侧凹陷有“S 10”和在其他侧Boehringer Ingelheim公司符号。
30片瓶(NDC 0597-0152-30)
90片瓶(NDC 0597-0152-90)
纸盒含3板各10片的泡罩药板(3x10)(NDC 0597-0152-37)，机构包装.
25 mg片：淡黄色，椭圆，双凹膜包衣片，在一侧凹陷有“S 25”和其他侧Boehringer Ingelheim公司符号。
30片瓶(NDC 0597-0153-30)
90片瓶(NDC 0597-0153-90)
纸盒含3板各10片泡罩药板(3x10)(NDC 0597-0153-37)，机构包装.
在一个由USP定义封闭良好容器内发放。
贮存
贮存在25°C(77°F)；外出允许至15°-30°C(59°-86°F)[见USP控制室温]。

完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
Jardiance® (empagliflozin) to be studied for the treatment of people with chronic heart failure
- New studies will evaluate the effect of JARDIANCE for the treatment of chronic heart failure
- There are approximately 26 million people worldwide, and 5.7 million people in the U.S., suffering from chronic heart failure
- The studies build on results from the landmark EMPA-REG OUTCOME® trial
RIDGEFIELD, Conn., and INDIANAPOLIS, April 19, 2016 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to conduct two outcome trials investigating the diabetes medicine Jardiance® (empagliflozin) for the treatment of people with chronic heart failure. The trials are targeted to begin within the next 12 months and are planned to enroll people with chronic heart failure both with and without type 2 diabetes (T2D).
JARDIANCE was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. This was demonstrated on top of standard of care (including glucose-lowering agents and CV drugs) in people with T2D at high risk of CV events. In addition to reducing CV death by 38 percent, the EMPA-REG OUTCOME® trial also showed that JARDIANCE reduced the risk of hospitalization for heart failure in people with T2D at high risk of CV events. These results led to the planned trials.
"The EMPA-REG OUTCOME trial demonstrated that JARDIANCE reduces the risk of cardiovascular death in diabetes patients at high CV risk, and we now look forward to exploring whether JARDIANCE can also provide heart failure benefits," said Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim.
"One in two people with heart failure die within five years of diagnosis, so there is currently a compelling need for an effective therapy to treat those suffering from this condition," said Javed Butler, M.D., cardiologist, Stony Brook University Hospital.
About Heart Failure
Heart failure is when the heart cannot pump enough blood around the body. It is a debilitating condition and can be fatal. Heart failure is a prevalent disease; 26 million people around the world and 5.7 million people in the U.S. have chronic heart failure. Every 35 seconds, a new case of heart failure is diagnosed in the U.S. There is a high unmet need in the treatment of heart failure as there is significant morbidity and mortality associated with the condition. Heart failure is highly prevalent in patients with diabetes, however, approximately two-thirds of all heart failure patients do not have diabetes.
About EMPA-REG OUTCOME Trial (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes at high risk for CV events.
The study assessed the effect of JARDIANCE (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Over a median of 3.1 years, JARDIANCE significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of JARDIANCE was consistent with that of previous trials.