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新类复方制剂Juvisync(降糖+降脂混合药)获美国批准上市

2015-04-29 10:32:37 作者：新特药房来源：互联网浏览次数：59 文字大小：【大】【中】【小】

简介： 首款同时患有糖尿病和高胆固醇的患者开发的混合治疗药物在美国上市2011年10月7日，美国食品药品管理局FDA批准Juvisync(西他列汀+辛伐他汀)用于治疗同时患有2型糖尿病和高脂血症的成人患者。Juvisync是一种 ...

关键字：西他列汀/辛伐他汀 sitagliptin and simvastatin 药品商标名Juvisync 用于治疗糖尿病和高胆固醇

首款同时患有糖尿病和高胆固醇的患者开发的混合治疗药物在美国上市
2011年10月7日，美国食品药品管理局FDA批准Juvisync(西他列汀+辛伐他汀)用于治疗同时患有2型糖尿病和高脂血症的成人患者。Juvisync是一种固定剂量复方制剂，其所含的两种药物此前均已获准。只允许对同时具有这两种药物适应证的患者开具这种复方制剂的处方。
西他列汀是一种二肽基肽酶-4抑制剂，可增强人体自身的降糖能力，已被批准与饮食和运动疗法联合用于改善成人2型糖尿病患者的血糖控制水平。辛伐他汀是3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂或称他汀类药物的一种，已获准与饮食和运动疗法联合用于降低血液低密度脂蛋白胆固醇水平。
Juvisync已获准的剂量强度包括(西他列汀/辛伐他汀)100mg/10mg、100mg/20mg和100mg/40mg三种。生产商已开始研发含有50mg西他列汀的药片，即Juvisync 50mg/10mg、50mg/20mg和50mg/40mg。在含有50 mg西他列汀的药片上市之前，需要使用该剂量药物的患者应服用单一成分的西他列汀药片。
Juvisync的最常见不良反应包括上呼吸道感染、鼻塞或流涕、咽痛、头痛、肌痛、腹痛、便秘和恶心。
FDA近期注意到，他汀类药物可能增加2型糖尿病患者的血糖水平。这一风险很低，并且远远不及他汀类药物降低糖尿病患者心脏病风险的收益。生产商被要求开展一项上市后临床试验，以比较西他列汀单药与西他列汀+辛伐他汀复方制剂的降糖功效。
Juvisync (sitagliptin phosphate and simvastatin)tablets, 100mg/10mg, 100mg/20mg, 100mg/40 mg, 50mg/10mg, 50mg/20mg, and 50mg/40mg
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New Drugs Online Report for sitagliptin + simvastatin
Information
Generic Name: sitagliptin + simvastatin
Trade Name: Juvisync
Synonym: MK-0431D
Entry Type: New formulation
Development and Regulatory status
UK: None
EU: None
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Sep 13: Merck announces it plans to stop selling Juvisync because of poor sales [3].
27/09/2013 11:42:43
Dec 11: Launched in the US [2].
27/09/2013 11:40:32
Oct 11: Approved in the US for treatment of T2DM and dyslipidaemia [2].
27/09/2013 11:40:05
Feb 11: Filed in the US for treatment of T2DM and also dyslipidaemia [2].
27/09/2013 11:39:32
Trial or other data
Sep 12: NCT01678820 A PIII, randomized, double-blind study of MK-0431D (a fixed-dose combination of sitagliptin 100mg and simvastatin 40mg) vs vs. sitagliptin alone for the treatment of 750 subjects with T2DM with inadequate glycaemic control on metformin monotherapy. The primary outcomes are: change from baseline in Hb A1C at week 16, the number of participants who experienced at least one adverse event and the number who discontinued from the study due to an adverse event. The study starts Oct 12 and is due to complete Oct 14 [1].
20/09/2012 12:26:11
References
Available only to registered users
Category
BNF Category: Antidiabetic drugs (06.01.02)
Pharmacology: Sitagliptin is a CD26 antigen antagonist and simvastatin is an HMG-CoA reductase inhibitor.
Epidemiology:
Indication: Type 2 diabetes mellitus
Method(s) of Administration
Oral
Company Information
Name: Merck Pharmaceuticals
US Name: Merck Pharmaceuticals
Further Information
Anticipated commissioning route (England) -
High cost drug list? Awaiting Update
Implications Available only to registered users