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FDA批准2型糖尿病一线复方治疗新药

FDA approves first-line combo therapy for type 2 diabetes

发布者:Frontline Medical News 发布时间:2016-10-11

The Food and Drug Administration approved an extended-release combination of canagliflozin and metformin for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes, according to Janssen Pharmaceuticals.

据杨森制药公司消息,FDA已批准坎格列净与二甲双胍缓释复方制剂作为一线辅助用药,结合饮食和锻炼,用于改善2型糖尿病成人患者血糖控制。

Once-daily Invokamet XR combines canagliflozin (Invokana) and an extended-release formulation of metformin. Studies in healthy adults have shown that Invokamet XR results in the same levels of canagliflozin and metformin in the body as when corresponding dosages of the two medicines are administered as separate tablets.

每天一次的Invokamet XR由坎格列净(Invokana)和缓释二甲双胍组成。研究显示健康成人服用Invokamet XR后,体内坎格列净和二甲双胍水平与分别服用相应剂量的两种药物一样。

Phase III studies showed that using canagliflozin and metformin lowered blood sugar and, in prespecified secondary endpoints, was linked to greater reductions in body weight and systolic blood pressure.

III期研究表明,服用坎格列净、二甲双胍降低血糖与降低体重收缩压相关(属于预设次要终点指标)。

Invokamet XR is available with 50 mg or 150 mg of canagliflozin, and 500 mg or 1,000 mg of extended-release metformin. Invokamet XR contains a boxed warning regarding the risk of lactic acidosis.

Invokamet XR含有50 mg或150 mg坎格列净和500 mg或1,000 mg缓释二甲双胍。Invokamet XR说明书中有乳酸酸中毒风险相关的黑框警告。

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来源: Frontline Medical News

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