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FDA批准地特胰岛素用于2~5岁1型糖尿病患儿

来源:环球医学编译    时间:2012年05月28日    点击数:    5星

5月58日消息 - 环球医学据悉,据地特胰岛素(Levemir)的制造商称,该药已获得FDA批准用于年龄2~5岁的1型糖尿病患儿。

诺和诺德公司表示,此次批准使地特胰岛素成为唯一获得FDA批准作为5岁及以下儿童基础治疗的胰岛素类似物。

此次批准基于一项涉及82例糖尿病患儿的试验,该试验对地特胰岛素与中性鱼精蛋白哈格多恩(NPH)胰岛素进行了比较。

在治疗一年后,接受两种胰岛素治疗的患儿的糖化血红蛋白水平均未发生临床上显著的变化,其糖化血红蛋白水平仍然低于美国糖尿病协会为6岁以下儿童设定的8.5%的目标。

此外,据诺和诺德公司称,亚组分析表明,在使用地特胰岛素+门冬胰岛素(NovoLog)(一种速效胰岛素)时,与NPH胰岛素+NovoLog相比,低血糖发作较为常见(平均50.6 vs 78.3次发作每患者年)。

据诺和诺德称,地特胰岛素组的不良事件率较低,为69.0%,而NPH组则为77.5%。

该公司表示,胃肠炎和消化不良是最常见的严重事件,在两个治疗组中的例数近似相等。

与其他儿科胰岛素产品一样,地特胰岛素也是通过注射给药。地特胰岛素已经获批用于年龄较大的儿童和成人1型糖尿病患者,以及用于成人2型糖尿病患者。(环球医学)

原文:

FDA OKs Levemir for Tots

Insulin detemir (Levemir) has received FDA approval for children ages 2 to 5 with type 1 diabetes, the product's manufacturer said.

Novo Nordisk said the approval makes insulin detemir the only FDA-approved insulin analog available for children 5 and younger as basal therapy.

Underlying the approval was a trial in 82 diabetic children that compared insulin detemir with neutral protamine Hagedorn (NPH) insulin. After one year of treatment, no clinically significant change in glycated hemoglobin levels was seen with either form of insulin, and the levels remained below the target of 8.5% set by the American Diabetes Association for children younger than 6.

Also, according to Novo Nordisk, a prespecified subgroup analysis indicated that hypoglycemia episodes were less common with insulin detemir plus insulin aspart (NovoLog), a rapid-acting insulin, compared with NPH insulin plus NovoLog (mean 50.6 versus 78.3 episodes per patient-year).

Adverse events overall were slightly less common with insulin detemir, according to Novo Nordisk, affecting 69.0% of children taking it versus 77.5% of those in the NPH insulin group.

Gastroenteritis and dyspepsia were the most common severe events, seen in about equal numbers in the two treatment groups, the company said.

Like other pediatric insulin products, insulin detemir is given by injection. It already was approved for older children and adults with type 1 diabetes and for adults with type 2 diabetes.
 

相关链接:http://www.medpagetoday.com/Endocrinology/Diabetes/32871 

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