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成人2型糖尿病治疗药物Jentadueto获FDA批准

2012-02-17 MedSci MedSci原创

糖尿病JentaduetoFDA
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勃林格殷格翰公司和礼来公司近日(NYSE: LLY)宣布Jentadueto(linagliptin/盐酸二甲双胍)片已经获得了美国食品和药品管理局 (FDA)的批准，该药是二肽基肽酶-4 (DPP-4)抑制剂 linagliptin和二甲双胍的新型复合片剂1。Linagliptin/盐酸二甲双胍的问世为需要改善血糖控制的2型糖尿病成年患者提供了全新的、每日服用两次的单一药片治疗选择1。 Lina

勃林格殷格翰公司和礼来公司近日(NYSE: LLY)宣布Jentadueto(linagliptin/盐酸二甲双胍)片已经获得了美国食品和药品管理局 (FDA)的批准，该药是二肽基肽酶-4 (DPP-4)抑制剂 linagliptin和二甲双胍的新型复合片剂1。Linagliptin/盐酸二甲双胍的问世为需要改善血糖控制的2型糖尿病成年患者提供了全新的、每日服用两次的单一药片治疗选择1。 Linagliptin (5 mg，每日给药一次)已经在美国以Tradjenta? (linagliptin)片的形式上市，在欧洲和加拿大则以Trajenta? 为商品名上市，在日本和其他市场则以 Trazenta? 为商品名上市2,3，目前在中国尚未上市。

Linagliptin/盐酸二甲双胍治疗应基于饮食控制和体育锻炼之上，这一处方药物可应用于适合接受linagliptin和二甲双胍治疗的2型糖尿病成年患者，用以改善这些患者的血糖控制水平。在使用最大给药剂量的时候，linagliptin/盐酸二甲双胍可使得安慰剂校正的血红蛋白A1c（HbA1c 或 A1C）出现高达1.7%的降幅 (安慰剂组为+0.1%，linagliptin/盐酸二甲双胍组为-1.6%)。A1C 是糖尿病检测指标之一，可反映最近2个月到3个月的血糖控制水平。Linagliptin/盐酸二甲双胍不会导致任何具有临床意义的体重改变。Linagliptin/盐酸二甲双胍可单独使用，也可与2型糖尿病常用药物磺脲类药物联合使用。Linagliptin/盐酸二甲双胍不应用于1型糖尿病或糖尿病酮症酸中毒 (血液或尿液中的酮体含量增高)，目前尚未对该药与胰岛素的联合使用开展过研究。Linagliptin/盐酸二甲双胍的产品标签中包含有关乳酸酸中毒的加框警示，乳酸酸中毒是一种严重的代谢性并发症，由linagliptin/盐酸二甲双胍治疗过程中产生的二甲双胍蓄积所导致1。

“由于2型糖尿病具有复杂的发病机制，大多数2型糖尿病患者需要接受一种以上的药物治疗以降低其血糖水平，”来自德州肾脏和内分泌疾病研究所的 Lance Sloan博士如此说道。“Jentadueto? 获得批准是一个令人兴奋的消息，因为这种药物将两种降糖药复合成为单一片剂，从而为那些需要一种以上药物治疗、而且适合接受linagliptin和二甲双胍的患者提供了很好的治疗选择。”

拓展阅读：

FDA批准默克Janumet缓释片用于治疗2型糖尿病

FDA批准缓释艾塞那肽获准抗II型糖尿病

成人2型糖尿病治疗药物Jentadueto获FDA批准

糖尿病新药Dapagliflozin被FDA否决

LX4211联合西他列汀治疗糖尿病临床研究完成

糖尿病新药研究动态汇集（附点评）

DPP-4抑制剂：破解2型糖尿病的治疗困境

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    2012-12-18 zhanglin3079

    #糖尿病治疗#

    0

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    2012-09-03 bugit

    #FDA批准#

    0

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    2012-05-03 zhaohui6731

    #Jentadueto#

    0

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    2012-03-23 周虎

    #治疗药物#

    0

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    2012-02-19 fengxx

    #成人2型糖尿病#

    0

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