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An anti-generic strategy that creates confusion

机译:一种产生混乱的反通用策略

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Not bioequivalent to insulin glargine 100 U per ml: remember to adjust the dose when switching from one concentration to the other. Insulin products dosed at 200 units per millilitre have been authorised in the European Union since 2013, even though they have no advantages over the previous standard concentration of 100 units per ml (1). In 2016, insulin glargine, a long-acting analogue of human insulin, is available at a new concentration of 300 units per ml (Toujeo0, Sanofi Aventis) and is marketed alongside the existing concentration of 100 units per ml (Lantus0). Four unblinded, randomised, non-inferiority trials in a total of about 3000 patients with type 1 or 2 diabetes showed that the impact of insulin glargine 300 units per ml on the HbA1c level was similar to that of insulin glargine 100 units per ml. Overall, the frequency of severe hypoglycaemia was similar with the two concentrations (2). One unit of Toujeo0 corresponds to one unit of insulin Lantus0, but the two products are not bioequivalent, meaning that a dose modification is sometimes necessary when switching from one to the other. The EU summary of product characteristics states that the difference can reach 20%. Adequate patient information and intensified glucose monitoring are necessary (2,3).
机译:与每毫升100 U甘精胰岛素生物等效:当从一种浓度切换到另一种浓度时,记得调整剂量。自2013年以来,欧盟已经批准了剂量为每毫升200单位的胰岛素产品,尽管它们与之前的每毫升100单位的标准浓度相比没有任何优势(1)。2016年,甘精胰岛素(人胰岛素的长效类似物)的新浓度为每毫升300单位(Toujeo,赛诺菲-安万特),与现有浓度每毫升100单位(Lantus0)一起上市。在总共约3000名1型或2型糖尿病患者中进行的四项非盲、随机、非劣效性试验表明,每毫升300单位甘精胰岛素对HbA1c水平的影响与每毫升100单位甘精胰岛素相似。总体而言,两种浓度的严重低血糖发生率相似(2)。一个单位的Toujeo0相当于一个单位的Lantus0胰岛素,但这两种产品并不生物等效,这意味着在从一种转换到另一种时,有时需要进行剂量调整。欧盟对产品特性的总结表明,差异可能达到20%。充分的患者信息和强化血糖监测是必要的(2,3)。

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    《Prescrire international》 |2016年第174期|共1页
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  • 正文语种 eng
  • 中图分类 药学;
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