Tradjenta获准作为胰岛素的追加治疗

圣路易斯(MD Consult)——2012年8月17日，礼来和勃林格殷格翰宣布，美国食品药品管理局(FDA)已批准Tradjenta(利拉利汀)片剂作为成人2型糖尿病胰岛素基础上的追加治疗。Tradjenta可与饮食和运动治疗相结合，降低成人2型糖尿病患者的血糖，可单独使用，也可与其他常用的2型糖尿病处方药物(如二甲双胍、磺脲类、吡格列酮或胰岛素)联合使用。

与此同时，FDA批准的产品标签中包含来自一项严重慢性肾功能损害患者临床研究的信息。这是一项为期52周的双盲、随机、安慰剂对照的试验，其结果显示，在这一患者人群中使用Tradjenta 5 mg加其他降糖治疗后糖化血红蛋白较安慰剂组显著降低。

FDA批准Tradjenta作为胰岛素的追加治疗，是基于一项为期52周的3期研究的数据，该研究旨在证实Tradjenta联合胰岛素治疗(加或不加二甲双胍和/或吡格列酮)的疗效。研究结果显示，在胰岛素基础上追加Tradjenta可获得优于单用胰岛素的血糖控制效果，并且两个治疗组的低血糖发生率相似。

严重低血糖事件定义为需要其他人援助并主动给予碳水化合物、胰高血糖素或采取其他复苏措施，Tradjenta和安慰剂组各报告发生3起严重低血糖事件，发生率分别为4.4%和4.6%。

Tradjenta治疗中最常见的不良反应包括鼻充血、流涕和咽喉痛。

Tradjenta是通过升高肠促胰素水平而发挥血糖依赖性降糖作用的，肠促胰素可升高餐后和全天的胰岛素水平。对于肾功能降低或肝脏受损的患者，无需进行剂量调整。Tradjenta的用法为每日1次，每次5 mg。

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ST LOUIS (MD Consult) - On August 17, 2012, Eli Lilly and Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes. Tradjenta is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes (eg, metformin, sulfonylurea, pioglitazone, or insulin).

Additionally, the FDA-approved label includes information from a clinical study in persons with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that the use of Tradjenta 5 mg plus other glucose-lowering therapies in this patient population provided a statistically significant improvement in glycated hemoglobin compared with placebo.

The FDA's decision to approve Tradjenta as add-on therapy to insulin was granted on the basis of data from a 52-week, phase 3 trial designed to demonstrate the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone). The trial results showed that adding Tradjenta to insulin produced better glucose control than insulin alone, with similar incidence of hypoglycemia in both treatment groups.

Severe hypoglycemic events, defined as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, were reported in 3 (4.4%) Tradjenta-treated patients and 3 (4.6%) placebo-treated patients.

The most common adverse effects of Tradjenta include nasal congestion, rhinorrhea, and sore throat.

Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day. No dose adjustment is required in patients with of declining renal function or with hepatic impairment. Tradjenta is administered as a 5-mg dose once daily.