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当前位置:药品说明书与价格首页 >> 糖尿病 >> Ⅱ型糖尿病 >> 药品目录 >> 利拉鲁肽注射剂Victoza(liraglutide)

利拉鲁肽注射剂Victoza(liraglutide)

2011-03-22 15:44:09  作者:新特药房  来源:中国新特药网天津分站  浏览次数:486  文字大小:【】【】【
简介: 制造商: 诺和诺德 药理分类: 降糖(胰高血糖素样肽1 [的GLP - 1]受体激动剂) 活性成分(补): 的liraglutide [rDNA来源] 6mg/mL;为SC已经来到溶液。 指示(补): 至于配合饮食和锻炼,以改善2型糖 ...

制造商:
诺和诺德

药理分类:
降糖(胰高血糖素样肽1 [的GLP - 1]受体激动剂)

活性成分(补):
的liraglutide [rDNA来源] 6mg/mL;为SC已经来到溶液。

指示(补):
至于配合饮食和锻炼,以改善2型糖尿病的血糖控制。

药理作用:
是人类的liraglutide的GLP - 1类似物,作为一个在的GLP - 1受体激动剂的行为。其特性不同的天然蛋白质,它具有更长的半衰期的,从而能够与剂量每日一次。其行动包括增加细胞内cAMP,胰岛素在血糖浓度的增加,存在释放的。这种胰岛素分泌补贴的血糖水平正常化。胰高血糖素分泌的liraglutide还降低和延缓胃的排空,这两者有助于其治疗效果。它已被证明可以减少空腹,餐前和餐后血糖在一天。

临床试验:
五双盲,随机,对照临床试验进行评估2型糖尿病管理的的liraglutide疗效。在这52周的单一疗法试验中,746例患者随机的liraglutide 1.2mg或1.8mg或格列美脲8mg。使用liraglutide治疗导致在格列美脲相比,糖化血红蛋白显着减少。

26周的研究,涉及1091例比较三种剂量的liraglutide(0.6mg,1.2mg和1.8mg),格列美脲4毫克和安慰剂作为附加二甲双胍治疗。作者的liraglutide 1.2mg和1.8mg除造成重大平均HbA1c与安慰剂相比,和一个类似的平均HbA1c格列美脲相比,减少减少。

在一个1041例26周的研究,比较三种剂量的liraglutide(0.6mg,1.2mg和1.8mg),罗格列酮4毫克和安慰剂作为附加疗法,格列美脲,使用liraglutide 1.2mg和1.8mg治疗导致在平均HbA1c显着降低,与安慰剂相比,作为附加到glimepiride。

581例中26周的研究的liraglutide 1.8mg,安慰剂相比,与胰岛素glargine作为附加二甲双胍和格列美脲治疗来。使用liraglutide治疗,附加在二甲双胍和格列美脲,在重大平均减少导致糖化血红蛋白与安慰剂相比,附加在二甲双胍和格列美脲。

最后,26个星期的试验比较的liraglutide 1.2mg,liraglutide1.8mg和安慰剂作为附加疗法,二甲双胍和罗格列酮8mg的2G。使用liraglutide作为治疗附加在罗格列酮加二甲双胍在一个平均HbA1c显着减少导致,而安慰剂。


法律分类:
接收

成人:
由资深大律师在给腹部,大腿,上臂或已经来到每日一次。最初0.6mg/day 1周,然后1.2mg/day;可能会增加到1.8mg/day。

儿童:
“18yrs:不推荐。

禁忌(补):
历史(个人或家庭)甲状腺髓样癌。多发性内分泌肿瘤综合征Ⅱ型。


警告/注意事项:
不适用于治疗1型糖尿病或酮症酸中毒。不建议用于第一线的不足,控制饮食和运动治疗。胰腺炎;监测标志/症状。肾或肝功能障碍。胃轻瘫。甲状腺癌的风险,并告知病人的症状。妊娠(Cat.C)。哺乳母亲:不推荐。

互动(补):
伴随胰岛素(没有足够的数据)。胰岛素低血糖泌(考虑减少其剂量)。可能影响(胃排空延迟)其他药物的吸收。监测地高辛。

不良反应(补):
头痛,胃肠不适,抗体​​形成,免疫反应(如荨麻疹),便秘,厌食,稀有:胰腺炎(停止如果发生),乳头状甲状腺癌。


如何提供:
多剂量,注射笔(3毫升)-2,3

VICTOZA


 

Manufacturer:

Novo Nordisk

Pharmacological Class:

Antidiabetic (glucagon-like peptide-1 [GLP-1] receptor agonist)

Active Ingredient(s):

Liraglutide [rDNA origin] 6mg/mL; soln for SC inj.

Indication(s):

As adjunct to diet and exercise, to improve glycemic control in type 2 diabetes.

Pharmacology:

Liraglutide is an analogue of human GLP-1 that acts as an agonist at GLP-1 receptors. Its properties differ from those of the native protein in that it has a longer half-life, enabling it to be dosed once-daily. Its actions include increasing intracellular cAMP, resulting in insulin release in the presence of increased glucose concentrations. This insulin secretion subsides as glucose levels normalize. Liraglutide also decreases glucagon secretion and delays gastric emptying, both of which contribute to its therapeutic effect. It has been shown to reduce fasting, premeal, and postprandial glucose throughout the day.

Clinical Trials:

Five double-blind, randomized, controlled clinical trials were conducted to assess the efficacy of liraglutide in the management of type 2 diabetes. In a 52-week monotherapy trial, 746 patients were randomized to liraglutide 1.2mg or 1.8mg or glimepiride 8mg. Treatment with liraglutide resulted in significant reductions in HbA1c compared to glimepiride.

A 26-week study involving 1091 patients compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), glimepiride 4mg, and placebo as add-on therapy to metformin. The addition of liraglutide 1.2mg and 1.8mg resulted in a significant mean HbA1c reduction compared to placebo and a similar mean HbA1c reduction compared to glimepiride.

In a 26-week study in 1041 patients that compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), rosiglitazone 4mg, and placebo as add-on therapy to glimepiride, treatment with liraglutide 1.2mg and 1.8mg resulted in a significant reduction in mean HbA1c , compared to placebo as add-on to glimepiride.

A 26-week study in 581 patients compared liraglutide 1.8mg, placebo, and insulin glargine as add-on therapy to metformin and glimepiride. Treatment with liraglutide, as add-on to metformin and glimepiride, resulted in significant mean reduction in HbA1c compared to placebo add-on to metformin and glimepiride.

Lastly, a 26-week trial compared liraglutide 1.2mg, liraglutide1.8mg, and placebo as add-on therapy to metformin 2g and rosiglitazone 8mg. Treatment with liraglutide as add-on to metformin plus rosiglitazone resulted in a significant reduction in mean HbA1c , compared to placebo.

Legal Classification:

Rx

Adults:

Give by SC inj in abdomen, thigh, or upper arm once daily. Initially 0.6mg/day for 1 week, then 1.2mg/day; may increase to 1.8mg/day.

Children:

<18yrs: not recommended.

Contraindication(s):

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Warnings/Precautions:

Not for treating type 1 diabetes or ketoacidosis. Not recommended for first-line treatment in patients inadequately controlled on diet and exercise. Pancreatitis; monitor for signs/symptoms. Renal or hepatic dysfunction. Gastroparesis. Inform patients of thyroid cancer risk and symptoms. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

Concomitant insulin (insufficient data). Hypoglycemia with insulin secretagogues (consider reducing their doses). May affect absorption of other drugs (delayed gastric emptying). Monitor digoxin.

Adverse Reaction(s):

Headache, GI upset, antibody formation, immunogenicity reactions (eg, urticaria), constipation, anorexia; rare: pancreatitis (discontinue if occurs), papillary thyroid carcinoma.

How Supplied:

Multi-dose, prefilled pen (3mL)—2, 3

Last Updated:

3/11/2010

责任编辑:admin


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