DuoPlavin

活性物质：氯吡格雷/乙酰水杨酸

俗名：氯吡格雷/乙酰水杨酸

ATC代码：B01AC30

营销授权持有人：Sanofi Pharma Bristol-Myers Squibb SNC

活性物质：氯吡格雷/乙酰水杨酸

状态：已授权

授权日期：2010-03-15

治疗领域：急性冠状动脉综合征心肌梗死

药物治疗组：抗血栓药

治疗指征

DuoPlavin适用于已经服用氯吡格雷和乙酰水杨酸（ASA）的成年患者的动脉粥样硬化血栓形成事件的二级预防。 DuoPlavin是一种固定剂量的组合药物，用于延续治疗：

•非ST段抬高急性冠状动脉综合征（不稳定型心绞痛或非Q波心肌梗死），包括经皮冠状动脉介入术后接受支架置入的患者;

•符合溶栓治疗条件的医学治疗患者的ST段抬高急性心肌梗死。

什么是DuoPlavin？

DuoPlavin是一种含有两种活性物质的药物，氯吡格雷和乙酰水杨酸（也称为阿司匹林）。它可以含有75mg氯吡格雷的片剂，含有75mg或100mg乙酰水杨酸。

DuoPlavin用于什么？

DuoPlavin用于预防已经同时服用氯吡格雷和乙酰水杨酸作为单独片剂的成人血栓和动脉硬化引起的问题，例如心脏病发作。它可用于以下患有“急性冠状动脉综合征”病症的患者群体：

•患有“不稳定性心绞痛”（严重类型的胸痛）或心脏病发作但没有“ST段抬高”（心电图或心电图读数异常）的患者，包括有支架的患者（短管插入动脉以防止其闭合;

•当医生认为他们将从溶栓治疗（溶解血栓的治疗）中受益时，患有ST段抬高的心脏病发作的患者。

该药只能通过处方获得。

DuoPlavin是如何使用的？

每天一次服用DuoPlavin作为一片，代替患者已经分开服用的氯吡格雷和乙酰水杨酸片剂。

DuoPlavin如何运作？

DuoPlavin，氯吡格雷和乙酰水杨酸中的两种活性物质都是抗血小板药。这意味着它们有助于防止称为血小板的血细胞粘在一起并形成凝块，从而有助于防止另一次心脏病发作。

氯吡格雷通过阻止一种名为ADP的物质附着在其表面的特殊受体上来阻止血小板粘在一起。这可以阻止血小板变得“粘稠”，从而降低血栓形成的风险。乙酰水杨酸通过阻断称为前列腺素环加氧酶的酶来阻止血小板粘在一起。这减少了称为血栓素的物质的产生，其通常通过将血小板附着在一起来帮助形成凝块。两种活性物质的组合具有累加效应，降低了血栓形成的风险，比单独使用任何一种药物都要多。

这两种活性物质已在欧盟（EU）上销售多年。氯吡格雷自1998年以来一直被授权用于减少血小板聚集，并且通常与乙酰水杨酸组合使用。乙酰水杨酸已有100多年的历史。

DuoPlavin是如何学习的？

由于这两种活性物质已经在一起使用了很多年，该公司提供的研究结果显示，DuoPlavin中的活性物质在单一片剂中以同样的方式吸收在体内，就像两种药物一样。单独拍摄。它还介绍了3项先前研究的结果，涉及超过61,000名患有不稳定型心绞痛或心脏病发作的患者。

DuoPlavin在研究期间表现出什么好处？

DuoPlavin被证明可与氯吡格雷和乙酰水杨酸分开摄取，因此可用于代替患者已服用的氯吡格雷和乙酰水杨酸片剂。

不稳定型心绞痛患者或心脏病发作患者的3项研究结果显示，氯吡格雷和乙酰水杨酸联合作为单独的片剂，比单用乙酰水杨酸更有效地预防心脏病发作等事件。

DuoPlavin的风险是什么？

DuoPlavin最常见的副作用（100例中1至10例患者）是血肿（皮下血液集合），鼻出血（流鼻血），胃肠道出血（胃或肠道出血），腹泻，腹痛（胃痛），消化不良（胃灼热），瘀伤和出血，皮肤被刺破。有关使用DuoPlavin报告的所有副作用的完整列表，请参阅包装说明书。

DuoPlavin不得用于对氯吡格雷，非甾体抗炎药（如乙酰水杨酸）或DuoPlavin中任何其他成分过敏（过敏）的人群。它不得用于患有导致出血的疾病的患者，例如胃溃疡或脑出血或患有肥大细胞增多症的患者（某些白细胞的高血液水平称为肥大细胞）。不得用于肝功能或肾功能严重下降的患者，或患有哮喘，鼻炎（鼻塞和流鼻涕）和鼻息肉（鼻内膜生长）等疾病的患者。在怀孕的最后三个月内不得使用DuoPlavin。

为什么DuoPlavin被批准了？

CHMP注意到DuoPlavin与单独服用的氯吡格雷和乙酰水杨酸片相当，并得出结论，将两种活性物质合并在一片DuoPlavin片剂中可以简化患者的治疗，因为他们需要服用较少的片剂。因此，委员会决定DuoPlavin的利益大于其风险，并建议获得上市许可。

关于DuoPlavin的其他信息

欧盟委员会于2010年3月15日授予DuoPlavin在整个欧盟有效的上市许可。

有关使用DuoPlavin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。

DuoPlavin

Active Substance: clopidogrel / acetylsalicylic acid
Common Name: clopidogrel / acetylsalicylic acid
ATC Code: B01AC30
Marketing Authorisation Holder: Sanofi Pharma Bristol-Myers Squibb SNC
Active Substance: clopidogrel / acetylsalicylic acid
Status: Authorised
Authorisation Date: 2010-03-15
Therapeutic Area: Acute Coronary Syndrome Myocardial Infarction
Pharmacotherapeutic Group: Antithrombotic agents

Therapeutic Indication

DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in:

· non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention;

· ST-segment-elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.

What is DuoPlavin?

DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin). It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.

What is DuoPlavin used for?

DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets. It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome’:

· patients who have ‘unstable angina’ (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation’ (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;

· patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).

The medicine can only be obtained with a prescription.

How is DuoPlavin used?

DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.

How does DuoPlavin work?

Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.

Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming. Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together. The combination of the two active substances has an additive effect, reducing the risk of blood clots forming, more than either medicine alone.

Both active substances have been available in the European Union (EU) for a number of years. Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.

How has DuoPlavin been studied?

Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately. It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.

What benefit has DuoPlavin shown during the studies?

DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.

Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.

What is the risk associated with DuoPlavin?

The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured. For the full list of all side effects reported with DuoPlavin, see the package leaflet.

DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells). It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose). DuoPlavin must not be used during the last three months of pregnancy.

Why has DuoPlavin been approved?

The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets. The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about DuoPlavin

The European Commission granted a marketing authorisation valid throughout the EU for DuoPlavin on 15 March 2010.

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