2012年9月24日,武田(Takeda)3种2型糖尿病新药:二肽基肽酶IV(DPP-4)抑制剂Vipidia(alogliptin)、固定剂量组合Vipdomet(alogliptin+二甲双胍)、Incresync(alogliptin+吡格列酮)均获得了欧盟委员会(EC)批准,用于现有疗法无法控制其血糖水平的2型糖尿病患者。
这3种新药的获批,是基于一项强有力的临床试验项目的数据。该项目涉及超过11000名患者,治疗时间长达4年,以及2项关键性研究的数据、ENDURE研究的一年数据及EXAMINE实验的中期数据。
该项目,将alogliptin作为饮食和运动的辅助(adjunct)疗法、以及将alogliptin作为其他几类降糖药物(如二甲双胍、吡格列酮、胰岛素、磺脲类药物)的附加(add-on)疗法进行了疗效研究。
这些研究中,每日一次25mg剂量alogliptin表现出了临床和统计学意义的HbA1c水平降低,同时表现出良好的整体耐受性和低血糖发生率。
此外,研究表明,与二甲双胍或吡格列酮单药治疗相比,alogliptin与二甲双胍或吡格列酮联合用药能够显着地改善血糖水平的控制。固定剂量组合药物Vipdomet(alogliptin-二甲双胍)和Incresync(alogliptin-吡格列酮)提供了额外的好处,可能有助于患者减少每日必须服用的药丸数量。
Alogliptin是一种选择性二肽基肽酶IV(DPP-4)抑制剂,该药于2010年4月获得日本卫生劳动福利部(MHLW)批准,目前以商品名Nesina销售。固定剂量组合(alogliptin-pioglitazone)于2011年在日本获批,以商品名Liovel销售。
Indication for
NESINA (alogliptin) 6.25 mg, 12.5 mg, and 25 mg Tablets
NESINA is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. NESINA is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in blood or urine).
Important Safety Information
NESINA (alogliptin) may not be right for everyone. NESINA can cause serious side effects.
Do not take NESINA if you are allergic to any of its ingredients.
Stop taking NESINA and contact your doctor or go to the nearest hospital emergency room right away if you experience swelling of your face, lips, throat, or other areas on your skin, difficulty swallowing or breathing, raised red areas on your skin (hives), skin rash, itching, flaking, or peeling, as these may be symptoms of a serious allergic reaction.
Inflammation of the pancreas (pancreatitis), which may be severe, can happen to people taking NESINA. Tell your doctor if you have ever had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, kidney problems, or liver problems. Stop taking NESINA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
NESINA may cause liver problems. Call your doctor right away if you experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of your skin or eyes.
If you take NESINA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take NESINA. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar include shaking or feeling jittery, sweating, fast heartbeat, change in vision, hunger, headache, change in mood, confusion, or dizziness.
Before taking NESINA, you should tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if NESINA can harm an unborn baby, or if it passes into breast milk.
The most common side effects of NESINA were stuffy or runny nose and sore throat (4.4%), headache (4.2%), and cold-like symptoms (upper respiratory tract infection; 4.2%).
Tell your doctor about all the medicines, vitamins, and supplements you take.
Talk to your doctor or healthcare professional. Please see full Prescribing Information, including Medication Guide for NESINA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.