ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.

The pen contains the rapid-acting insulin analog Apidra.

The approval of Apidra SoloSTAR follows the approval and launch of Lantus SoloSTAR (insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus and Apidra to help manage their blood sugar will now have two pen delivery devices to make insulin administration convenient. Basal-prandial insulin regimens that combine once-daily Lantus as a basal insulin analog with rapid-acting Apidra at meal time can closely mimic normal physiologic insulin secretion.

The pens are the result of over 4 years of intensive development and are designed with different colors to help patients differentiate between the two pens, which are intended for use with 2 very different types of insulins (rapid-acting vs. long-acting).

The differentiation of the two pens was shown in a specific comparative study. Nevertheless, before using them, patients should carefully examine the labeling on the pen to ensure they are using the correct one.

Apidra SoloSTAR is expected to be available in pharmacies in 2009. For more information about Apidra or Apidra SoloSTAR, see www.Apidra.com.
 

圣路易斯 (MD Consult)——美国FDA批准了一种一次性预充式胰岛素笔——Apidra SoloSTAR[格鲁辛胰岛素(rDNA)注射剂]用于改善成人及儿童(≥4岁)1型糖尿病患者或成人2型糖尿病患者的血糖控制情况。

该胰岛素笔的内容物为速效胰岛素类似物Apidra。

继2007年来得时[Lantus SoloSTAR，甘精胰岛素(rDNA)注射剂]获得批准和上市后，Apidra SoloSTAR又获得批准。这样，需同时应用来得时和Apidra控制血糖的糖尿病患者，在这两种药物都有了笔式给药装置后，使用起来将更为便利。基础餐时治疗方案(“三短一长”胰岛素治疗方案)结合每天一次的来得时作为基础胰岛素治疗以及餐时Apidra快速治疗，这样就很接近正常的生理性胰岛素分泌模式。

这两种胰岛素笔是由研究者历经4年精心研制而成，被设计成了不同的颜色，以帮助患者区分填充了2种截然不同胰岛素(速效和长效)的笔。

一项特殊的比较性研究揭示了这两种胰岛素笔的区别。建议患者在使用之前，仍应仔细检查笔上的说明，以保证使用的是正确的笔。

Apidra SoloSTAR有望于2009年上市。关于Apidra或Apidra SoloSTAR更多的信息，请参阅下列网址：www.Apidra.com

 

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