DuoCover 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 clopidogrel, either with 75 mg (yellow) or 100 mg acetylsalicylic acid (pink).
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
DuoCover is used to prevent atherothrombotic events (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. It can be used in the following groups of patients who have a condition known as ?acute coronary syndrome?:
patients who are having unstable angina a severe type of chest pain or a myocardial infarction heart attack with no ST-segment elevation an abnormal reading on the ECG or electrocardiogram, including in patients 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.
DuoCover 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.
Both active substances in DuoCover, clopidogrel and acetylsalicylic acid, are ?inhibitors of platelet aggregation?. This means that they help to prevent cells in the blood called platelets from aggregating (sticking together) and forming clots. Clopidogrel stops the platelets aggregating 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 aggregating by blocking an enzyme called prostaglandin cyclo oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together. When taken together, the two active substances can reduce the risk of problems due to blood clots forming, helping to prevent another heart attack.
Both active substances have been available in the European Union (EU) for a number of years. Clopidogrel has been authorised as Plavix and Iscover since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.
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 DuoCover are absorbed in the body in the same way as the two medicines taken separately. It also presented the results of previous studies involving over 60,000 patients with acute coronary syndrome, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was effective at preventing atherothrombotic events such as heart attacks.
DuoCover 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.
The most common side effects with DuoCover (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 DuoCover, see the Package Leaflet.
DuoCover should not be used in people who may be hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoCover. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain. It must not be used in patients who have 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). DuoCover must not be used during the last three months of pregnancy.
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 combining both active substances in a single DuoCover tablet simplifies treatment for patients as they will need to take fewer tablets. The Committee therefore decided that DuoCover?s benefits are greater than its risks and recommended that it be given marketing authorisation.