What is DuoCover?
DuoCover is a medicine containing 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) or 100 mg (pink) of acetylsalicylic acid.
What is DuoCover used for?
DuoCover is used in the prevention of atherothrombotic events (problems caused by blood clots and arterial tightening), 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 with myocardial infarction (heart attack) without "ST tract elevation" (ECG abnormalities or electrocardiogram, including patients with stent placement (tube) in an artery to prevent clogging);
patients receiving treatment for a heart attack with ST segment elevation, when the doctor believes that thrombolytic treatment is beneficial to patients (therapy to dissolve blood clots).
The medicine can only be obtained with a prescription.
How is DuoCover used?
DuoCover should be taken in one tablet a day instead of the clopidogrel tablets and acetylsalicylic acid that the patient took separately.
How does DuoCover work?
Both active ingredients contained in DuoCover, clopidogrel and acetylsalicylic acid, are "inhibitors of platelet aggregation", ie they help prevent cells in the blood, called platelets, from aggregating (binding to each other) and forming clots. Clopidogrel blocks platelet aggregation by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents the platelets from becoming "sticky", reducing the risk of blood clots forming. Acetylsalicylic acid stops platelet aggregation by blocking an enzyme called prostaglandin cyclooxygenase. This reduces the production of a substance called thromboxane, which normally facilitates the formation of clots by binding the platelets together. If taken together, the two active ingredients can reduce the risk of problems due to the formation of 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 as Plavix and Iscover since 1998 for the reduction of platelet aggregation, and is often used in combination with acetylsilicylic acid. Acetylsalicylic acid has been available for over 100 years.
What studies have been carried out on DuoCover?
Since the 2 active ingredients have been used together for some years, the company presented the results of studies showing that the active ingredients present in DuoCover are absorbed by the body in the same way as the two medicines taken separately. He also presented the results from studies carried out on over 60, 000 patients with acute coronary syndrome, in which it is shown 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 DuoCover shown during the studies?
DuoCover has been shown to be comparable to clopidogrel and acetylsalicylic acid taken separately and can therefore be used instead of the clopidogrel tablets and acetylsalicylic acid that patients already take.
What are the risks associated with DuoCover?
The most common side effects associated with DuoCover (seen in between 1 and 10 patients in 100) are hematoma (accumulation of blood under the skin), epistaxis (nasal haemorrhage), gastrointestinal haemorrhage (bleeding in the stomach or intestines), diarrhea, pain abdominal (stomach ache), dyspepsia (heartburn), bruises and bleeding at the injection site. For the full list of all side effects reported with DuoCover, see the Package Leaflet.
DuoCover should 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 DuoCover. It must not be used in patients suffering from a disease with ongoing bleeding, such as a stomach ulcer or intracranial bleeding. It should not be used in patients with severe liver or kidney problems, or who are suffering from a medical condition that includes a combination of asthma, rhinitis (filled and runny nose) and nasal polyps (growths in the nasal mucosa). DuoCover should not be used in the last three months of pregnancy.
Why has DuoCover been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that DuoCover is comparable to clopidogrel and acetylsalicylic acid tablets taken separately and concluded that the combination of both active substances in a single tablet of DuoCover simplifies the treatment for patients, since they have to take fewer tablets. The Committee therefore decided that DuoCover's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on DuoCover
On March 15, 2010, the European Commission issued a marketing authorization for DuoCover to Bristol Myers Squibb Pharma EEIG, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for DuoCover can be found here. For more information on DuoCover therapy, read the package leaflet (also part of the EPAR).
Last update of this summary: 01-2010.
