2017年12月20日美国FDA批准ertugliflozin（商标名 Steglatro 默沙东生产）上市，用于改善成人2型糖尿病患者的血糖控制。这是近一个月来FDA批准的第二款糖尿病新药，也是2017年FDA批准上市的第45款新药，这一数字已经追平了1996年以来FDA每年批准新药数量的最高记录。

二型糖尿病原名叫成人发病型糖尿病，多在35-40岁之后发病，占糖尿病患者90%以上。2型糖尿病患者体内无法产生足够的胰岛素或有的患者体内胰岛素产生过多，但是胰岛素作用效果较差，从而导致患者失去正常的血糖调控能力。2型糖尿病患者容易出现一系列严重的并发症，因此急需更多的血糖控制方案。

糖尿病新药Steglatro是一种口服SGLT-2抑制剂。SGLT-2主要在肾脏表达，而SGLT-1部分在肾脏表达，主要表达于肠道。约90%的葡萄糖通过近曲小管S1段SGLT-2的作用被重吸收，约10%的葡萄糖通过近曲小管S3段SGLT-1的作用被重吸收。也就是说，SGLT-2在葡萄糖的重吸收中起主要的作用，SGLT-2转运肾重吸收葡萄糖的90%，而SGLT-1 只占其余10%。因此，SGLT-2的抑制剂可以阻断近曲小管对葡萄糖的重吸收而通过尿排出多余的葡萄糖，从而达到降低血糖的目的。

ertugliflozin（商标名 Steglatro）推剂量为：每天一次，每天一次，早晨服用，不论有无食物

完整治疗资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6f3e718-bb99-48f1-ab94-b9f0af05fed6

Steglatro (Ertugliflozin Tables for Oral Use)

STEGLATRO Rx

Generic Name and Formulations:

Ertugliflozin 5mg, 15mg; tabs. 

Company:

Merck & Co., Inc.

Indications for STEGLATRO:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations Of use:

Not for treating type 1 diabetes mellitus or diabetic ketoacidosis.

Adult:

Take in the AM (with or without food). Initially 5mg once daily; if tolerated and need additional glycemic control; may increase to max 15mg once daily. Renal impairment: if eGFR 30–<60mL/min/1.73m2: do not initiate; if persistently between 30–<60mL/min/1.73m2: continued use is not recommended.

Children:

<18yrs: not established.

Contraindications:

Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis.

Warnings/Precautions:

Correct volume depletion before initiating. Monitor for signs/symptoms of hypotension (esp. elderly, patients with renal impairment, low systolic BP, or on diuretics). Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, eva luate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). eva luate renal function prior to starting and monitor periodically thereafter. Consider factors that may predispose to acute kidney injury including hypovolemia, chronic renal insufficiency, CHF, and on concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Increased risk of genital mycotic infections or UTIs (including urosepsis, pyelonephritis); monitor and treat if occurs. Before initiating, consider factors that may increase risk of amputation (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infections, new pain/tenderness, sores or ulcers of the lower limbs; discontinue if occur. Monitor for increases in LDL-C; treat if occur. Severe hepatic impairment: not recommended. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Interactions:

Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. Possible hypotension with concomitant diuretics; monitor. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decrease, thirst.

Generic Availability:

NO

How Supplied:

Tabs—30, 90, 500