What is DuoPlavin?
DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin). It is available as oval tablets containing 75 mg of clopidogrel, with 75 mg (yellow colored) or 100 mg (pink colored) of acetylsalicylic acid.
What is DuoPlavin used for?
DuoPlavin is used to prevent atherothrombotic events (problems caused by blood clots and stiffening of the arteries), such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid. It can be used in the following groups of patients with a condition known as 'acute coronary syndrome':
patients with "unstable angina" (acute chest pain) or myocardial infarction (heart attack) without "ST segment elevation" (ECG or electrocardiogram abnormalities, including patients with stent (tube) placement in an "artery to prevent obstruction");
patients being treated for a heart attack with an ST segment elevation, when the doctor thinks that thrombolytic treatment is beneficial to the patients (therapy to dissolve blood clots).
The medicine can only be obtained with a prescription.
How is DuoPlavin used?
DuoPlavin is taken as one tablet per day in place of the clopidogrel and acetylsalicylic acid tablets that the patient was taking separately.
How does DuoPlavin work?
Both of the active ingredients contained in DuoPlavin, clopidogrel and acetylsalicylic acid, are 'platelet aggregation inhibitors', meaning they help prevent blood cells called platelets from aggregating (binding to each other) and forming clots. Clopidogrel blocks the clumping of platelets by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents platelets from becoming "sticky", reducing the risk of blood clots forming. Acetylsalicylic acid stops the blood clots. "Platelet aggregation by blocking an enzyme called prostaglandin cyclooxygenase. This reduces the production of a substance called thromboxane, which normally facilitates clot formation by binding platelets together. When taken together, the two active substances can reduce the risk of problems due to the formation of blood clots. blood clots, helping to prevent another heart attack.
Both active substances have been available in the European Union (EU) for several years. Clopidogrel has been authorized under the names Plavix and Iscover since 1998 for the reduction of platelet aggregation, and is often used in combination with acetylsilicylic acid. L "acetylsalicylic acid has been available for over 100 years.
How has DuoPlavin been studied?
Since the 2 active substances have been used together for some years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed by the body in the same way as the two medicines taken separately. It also presented the results from studies involving over 60,000 patients with acute coronary syndrome, showing that the combination of clopidogrel and acetylsalicylic acid as separate tablets is effective in the prevention of atherothrombotic events such as heart attacks.
What benefit has DuoPlavin shown during the studies?
DuoPlavin has been 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 patients are already taking.
What are the risks associated with DuoPlavin?
The most common side effects associated with DuoPlavin (seen in 1 to 10 patients in 100) are hematoma (accumulation of blood under the skin), epistaxis (nosebleed), gastrointestinal haemorrhage (bleeding in the stomach or intestines), diarrhea, pain abdominal pain (stomach pain), dyspepsia (heartburn), bruises and bleeding at the injection site. For the full list of side effects reported with DuoPlavin, see the package leaflet.
DuoPlavin must not be used in people who may be hypersensitive (allergic) to clopidogrel, stereodal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients of DuoPlavin. It must not be used in patients with ongoing bleeding disease, such as stomach ulcer or intracranial haemorrhage.It must not be used in patients with severe liver or kidney problems, 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 should not be used in the last three months of pregnancy.
Why has DuoPlavin been approved?
The Committee for Medicinal Products for Human Use (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 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 authorization.
More information about DuoPlavin
On March 15, 2010, the European Commission granted Sanofi Pharma Bristol Myers Squibb SNC a "Marketing Authorization" for DuoPlavin, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after of which it can be renewed.
For the full version of the DuoPlavin EPAR click here. For more information on DuoPlavin therapy, please read the package leaflet (included with the EPAR).
Last update of this summary: 01-2010.
The information on DuoPlavin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
