英文药名：Cholib tab（fenofibrate/simvastatin）

中文药名：非诺贝特/辛伐他汀复方片剂

生产厂家：雅培医疗
药品介绍
通用名：非诺贝特/辛伐他汀
上市许可持有人：雅培
活性物质：非诺贝特/辛伐他汀
授权日期：2013年8月26日
治疗领域：血脂异常
药物治疗组：血脂调节剂
治疗适应症
Cholib表示作为辅助治疗，以饮食和锻炼心血管疾病高风险的成年患者的混合血脂异常，降低甘油三酯和升高HDL C水平时，LDL C水平得到充分的辛伐他汀单药治疗的相应剂量的控制。
Cholib tab（fenofibrate/simvastatin）
What is Cholib and what is it used for?
Cholib is a medicine for improving blood fat levels. It contains two active substances, fenofibrate and simvastatin, and is used together with a low-fat diet and exercise with the aim of reducing patients’ levels of triglycerides (a type of fat) and increasing their levels of ‘good’ cholesterol (high-density-lipoprotein [HDL] cholesterol). Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad’ cholesterol (low-density-lipoprotein [LDL] cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
How is Cholib used?
Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Cholib can only be obtained with a prescription and is available as tablets (145/ 20mg and 145/40mg). The recommended dose is one tablet a day to be swallowed whole with a glass of water. Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
How does Cholib work?
The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Fenofibrate is a ‘PPARa agonist’. This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha’ (PPARa), which is involved in breaking down fats from diet, especially triglycerides. When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad’ cholesterol and triglycerides.
The second active substance, simvastatin, belongs to the group called ‘statins’. It reduces total blood cholesterol by blocking the action of 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA) reductase, an enzyme in the liver involved in the production of cholesterol. As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further. The cholesterol drawn out of the blood in this way is the ‘bad’ cholesterol.
What benefits of Cholib have been shown in studies?
Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
In a main study comparing Cholib 145 / 20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin. In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Another study compared Cholib 145 / 40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone. It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
What are the risks associated with Cholib?
The most common side effects with Cholib are raised blood creatinine levels, upper-respiratory-tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme). For the full list of all side effects reported with Cholib, see the package leaflet.
Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine. It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates. For the full list of restrictions, see the package leaflet.
Why is Cholib approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels. In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone. The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns. The Committee therefore concluded that Cholib’s benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Cholib?
A risk-management plan has been developed to ensure that Cholib is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Cholib
The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
CHOLIB 145mg/20mg - Filmtabletten  - 092389 - ABBOTT HEALTHCARE SAS, CHATILLON, F-CHATILLON SUR CHALARONNE - ABBOTT GMBH, WIEN

CHOLIB 145mg/40mg - Filmtabletten  - 092390 - ABBOTT HEALTHCARE SAS, CHATILLON, F-CHATILLON SUR CHALARONNE - ABBOTT GMBH, WIEN

EMA批准非诺贝特/辛伐他汀复方制剂控制血脂
欧洲药品管理局（EMA）人用医药产品委员会（CHMP）建议批准非诺贝特/辛伐他汀复方片剂（Cholib，雅培医疗，Abbott Park，IL）作为高风险混合型血脂异常患者饮食和运动治疗的辅助疗法
145 mg/40 mg和145 mg/20mg两种剂量的非诺贝特/辛伐他汀片获得了CHMP的积极评价。
该药物被批准用于辛伐他汀20mg或40mgLDL胆固醇水平控制不佳的心血管高风险患者，降低甘油三酯，升高HDL胆固醇水平。
Cholib最常见的不良事件包括上呼吸道感染、肠胃炎、血小板计数增加、谷丙转氨酶和血肌酐升高。委员会称，基于所提交的药品质量、安全性和疗效数据，CHMP认为Cholib具有良好的受益-风险平衡，因此建议准予上市。
CHMP的积极评价是欧盟委员会批准药物上市的先决条件，从意见发布到批准上市之间还有67天的等待期。