FDA批准两药复方片Jentadueto用于治疗2型糖尿病

ST LOUIS (MD Consult) - On January 30, 2012, Eli Lilly and Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) to improve glycemic control in adults with type 2 diabetes. The medication is intended for use along with diet and exercise in patients for whom treatment with both linagliptin and metformin is appropriate. Jentadueto can be used alone or in combination with a sulphonylurea.

The linagliptin/metformin combination was approved on the basis of results from clinical trials that evaluated linagliptin and metformin as separate tablets. At the maximum dose, the use of the combination of linagliptin and metformin demonstrated placebo-corrected reductions in hemoglobin A_1c levels of up to 1.7% (+0.1% for placebo and -1.6% for linagliptin/metformin). Bioequivalence of linagliptin/metformin was demonstrated with coadministered linagliptin and metformin tablets in healthy study participants.

Adverse reactions reported in ≥ 5% of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis and diarrhea. Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto and sulfonylurea compared with patients treated with the combination of placebo, sulfonylurea, and metformin (22.9% vs 14.8%, respectively). In studies, the use of linagliptin/metformin was not associated with any meaningful change in body weight.

The Jentadueto label contains a Boxed Warning for the risk of lactic acidosis.

Jentadueto is an oral tablet taken twice daily.

圣路易斯(MD Consult)——2012年1月30日，礼来公司和勃林格殷格翰公司宣布美国食品药品管理局(FDA)已批准Jentadueto(利拉利汀/盐酸二甲双胍)用于改善成人2型糖尿病患者的血糖控制。该药适合作为饮食和运动疗法的辅助用药，用于同时适宜采用利拉利汀和二甲双胍治疗的患者。Jentadueto既可以单独用药，也可以与磺酰脲联合用药。

FDA批准利拉利汀/二甲双胍复方制剂是基于评价利拉利汀和二甲双胍作为单独片剂治疗糖尿病的临床试验结果。在最大剂量下，利拉利汀/二甲双胍组的血红蛋白A_1c相对于安慰剂组的降幅达到1.7%(安慰剂组为+0.1%，利拉利汀/二甲双胍组为-1.6%)。健康受试者联合服用利拉利汀片和二甲双胍片显示与服用利拉利汀/二甲双胍复方制剂具有生物等效性。

Jentadueto治疗组中有≥ 5%的患者报告发生不良反应，该比例大于安慰剂对照组，不良反应包括鼻咽炎和腹泻。Jentadueto+磺酰脲联合治疗组与安慰剂+磺酰脲+二甲双胍联合治疗组相比，其报告发生低血糖的患者比例较高(分别为22.9% vs. 14.8%)。在这些研究中，服用利拉利汀/二甲双胍与任何明显的体重变化均无相关性。

Jentadueto的说明书中包含一个有关乳酸酸中毒的黑框警告。

Jentadueto是一种口服片剂，每日服用2次。

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