Pravafenix

活性物质：非诺贝特/普伐他汀

俗名：非诺贝特/普伐他汀

ATC代码：C10BA03

营销授权持有人：Laboratoires SMB S.A.

活性物质：非诺贝特/普伐他汀

状态：已授权

授权日期：2011-04-14

治疗领域：血脂异常

药物治疗组：脂质修饰剂

治疗指征

Pravafenix适用于治疗高冠心病（CHD）风险的混合性血脂异常成人患者，其特征为高甘油三酯和低HDL-胆固醇（C）水平，其LDL-C水平在接受治疗时得到充分控制。普伐他汀-40-mg单药治疗。

什么是Pravafenix？

Pravafenix是一种含有普伐他汀和非诺贝特活性物质的药物。它有绿色和橄榄色胶囊，含有40毫克普伐他汀和160毫克非诺贝特。

Pravafenix用于什么？

Pravafenix用于心脏病高风险的成人，其“低密度脂蛋白”（LDL或“坏”）胆固醇已经单独用普伐他汀控制，但仍需要提高胆固醇水平并降低其甘油三酯水平（一种脂肪）。

该药只能通过处方获得。

Pravafenix如何使用？

在开始使用Pravafenix进行治疗之前，医生应首先调查患者胆固醇和甘油三酯水平异常的所有可能原因，并让患者适当饮食。

推荐剂量是在晚餐期间每天服用一粒胶囊。药物应始终与食物一起服用，因为空腹吸收不太好。应定期监测患者的血液，看看药物是如何起作用的。如果在三个月内没有看到足够的反应，医生应该停止治疗。

Pravafenix如何运作？

Pravafenix，普伐他汀和非诺贝特中的活性物质以不同的方式起作用，它们的作用具有互补作用。

普伐他汀属于“他汀类药物”。它通过阻断3-羟基-3-甲基 - 戊二酰辅酶A（HMG-CoA）还原酶（一种参与胆固醇生成的肝脏中的酶）的作用来降低总血液胆固醇。由于肝脏需要胆固醇来产生胆汁，降低的血液胆固醇水平会导致肝细胞产生从血液中吸取胆固醇的受体，从而进一步降低其水平。以这种方式从血液中抽出的胆固醇是低密度脂蛋白，或“坏”胆固醇。

非诺贝特是一种“过氧化物酶体增殖物激活受体（PPAR）激动剂”。它激活一种叫做“PPARα”的受体，它参与分解饮食中的脂肪，特别是甘油三酯。当受体被激活时，脂肪的分解加速，这有助于清除血液中的胆固醇和甘油三酯。

Pravafenix是如何被研究的？

由于普伐他汀和非诺贝特已用于药物多年，该公司除了自己的研究结果外，还提供了科学文献的信息。

该公司进行了一项主要研究，其中将Pravafenix与仅有普伐他汀的248例心脏病高风险患者进行了比较，这些患者的胆固醇和甘油三酯脂肪含量异常。有效性的主要衡量指标是12周后胆固醇水平降低（不包括HDL或“好”胆固醇）。

Pravafenix在研究期间表现出什么好处？

在主要研究中，Pravafenix在降低非HDL-胆固醇水平方面比单用普伐他汀更有效。服用Pravafenix的患者非HDL-胆固醇水平平均降低约14％，而单独使用普伐他汀的患者平均降低6％。

Pravafenix的风险是什么？

Pravafenix最常见的副作用（100例中1~10例患者）腹胀（腹胀），腹痛（腹痛），便秘，腹泻，口干，消化不良（胃灼热），e气（bel气），肠胃气胀（气），恶心（感觉不舒服），腹部不适，呕吐和肝酶升高的血液水平。有关使用Pravafenix报告的所有副作用的完整列表，请参阅包装说明书。

Pravafenix不应用于可能对活性物质或任何其他成分过敏（过敏）的人。 Pravafenix不得用于18岁以下的患者或患有严重肝脏问题，中度至重度肾脏问题，光过敏或光毒性反应（过敏反应或由于光线照射造成的皮肤损伤）的患者在贝特类或贝洛芬治疗期间。在用他汀类药物或贝特类药物治疗后，它也不能用于患有胆囊疾病，慢性或急性胰腺炎（胰腺炎症）或肌病史（肌肉疾病）或横纹肌溶解症（肌纤维分解）的患者。绝不能给怀孕或哺乳的妇女。

为什么Pravafenix被批准了？

CHMP研究了新发布的他汀类和非诺贝特联合治疗的益处数据。委员会还注意到，Pravafenix的益处主要在于甘油三酯脂肪含量高且HDL胆固醇水平低的患者。因此，委员会决定Pravafenix的益处大于其在这组患者中的风险，并建议获得上市许可。

关于Pravafenix的其他信息

欧盟委员会授予整个欧盟Pravafenix有效的上市许可证SMB s.a. 2011年4月14日。上市许可有效期为五年，之后可以续订。

有关使用Pravafenix治疗的更多信息，请阅读包装说明书（也是EPAR的一部分）或联系您的医生或药剂师。

Active Substance: fenofibrate / pravastatin
Common Name: fenofibrate / pravastatin
ATC Code: C10BA03
Marketing Authorisation Holder: Laboratoires SMB S.A.
Active Substance: fenofibrate / pravastatin
Status: Authorised
Authorisation Date: 2011-04-14
Therapeutic Area: Dyslipidemias
Pharmacotherapeutic Group: Lipid-modifying agents

Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.

Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate. It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.

Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein’ (LDL or ‘bad’) cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).

The medicine can only be obtained with a prescription.

Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient’s abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.

The recommended dose is one capsule a day taken during the evening meal. The medicine should always be taken with food as it is less well absorbed from an empty stomach. The patient’s blood should be monitored regularly to see how the medicine is working. The doctor should stop treatment if an adequate response is not seen within three months.

The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.

Pravastatin belongs to the group called ‘statins’. It reduces total blood cholesterol by blocking the action of 3-hydroxy-3-methyl-glutaryl-coenzyme-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 LDL, or ‘bad’ cholesterol.

Fenofibrate is a ‘peroxisome-proliferator-activated-receptor (PPAR) agonist’. It activates a type of receptor called the ‘PPAR alpha’, which is involved in breaking down fat from the diet, especially triglycerides. When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.

Because pravastatin and fenofibrate have been used in medicines for a number of years, the company presented information from the scientific literature in addition to results from its own studies.

The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats. The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks (excluding HDL or ‘good’ cholesterol).

In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing non-HDL-cholesterol levels. Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.

The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes. For the full list of all side effects reported with Pravafenix, see the package leaflet.

Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients. Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo-allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen. It must also not be used in patients with gall-bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate. It must not be given to women who are pregnant or breastfeeding.

The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate. The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol. The Committee therefore decided that Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.