What is Iscover?
Iscover is a medicine that contains the active substance clopidogrel. It is available in the form of pink tablets (round: 75 mg; oblong: 300 mg).
What is Iscover used for?
Iscover is indicated for the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Iscover can be given to the following patient groups:
- patients who have had a recent myocardial infarction (heart attack). Treatment with Iscover can begin between a few days and 35 days after the heart attack;
- patients who have had a recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Iscover can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood circulation in the arteries);
- patients with a condition known as "acute coronary syndrome", who should be given aspirin (another medicine to prevent blood clots), including patients who have a stent (a tube inserted into an "artery to prevent blood clots). the "obturation). Iscover can be used in patients who have a heart attack with "ST segment elevation" (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks the treatment would be beneficial. It can also be used in patients who do not have such a reading. abnormal on the ECG, if you have unstable angina (a severe form of chest pain) or a 'non-Q-wave' myocardial infarction.
The medicine can only be obtained with a prescription.
How is Iscover used?
The standard dose of Iscover is one 75 mg tablet once daily with or without meals. In acute coronary syndrome, Iscover is associated with aspirin, and treatment usually begins with a loading dose of one 300 mg tablet or four 75 mg tablets. This dose is then followed by the standard dose of 75 mg once daily for at least four weeks (in ST-segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Inside the organism Iscover is converted into the active form. For genetic reasons, some people may not be able to convert Iscover as effectively as other patients, which could lower the degree of response to the medicine. The most suitable dose for this type of patient has not been identified.
How does Iscover work?
The active substance in Iscover, clopidogrel, is an inhibitor of platelet aggregation: it helps prevent the formation of blood clots. The blood clots when some special blood cells, platelets, clump together (stick to each other). other). Clopidogrel blocks the clumping of platelets 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 and helping to prevent recurrence of heart attacks or strokes.
How has Iscover been studied?
Iscover as an anticoagulant was compared with aspirin in a study called CAPRIE involving around 19,000 patients who had recently had a heart attack or ischemic stroke or had known peripheral arterial disease. The main measure of effectiveness is. was the number of patients who experienced a new "ischemic event" (heart attack, ischemic stroke or death) over a period of one to three years.
For acute coronary syndrome, Iscover was compared with placebo (a dummy treatment) in a study involving over 12,000 patients without ST-segment elevation, 2 172 of whom had a stent implanted in the course of study (CURE study, lasted up to one year) Iscover was also compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved more than 3,000 patients and lasted for up to eight days , and COMMIT performed on nearly 46,000 patients who received Iscover with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks. In the acute coronary syndrome studies, all patients also had taken aspirin and the main measure of effectiveness was based on the number of subjects reporting an "event", such as an arterial block or other heart attack, or also that they had died in the course of the study.
What benefit has Iscover shown during the studies?
Iscover was more effective than aspirin in preventing new ischemic events. During the CAPRIE study, there were 939 events in the Iscover group and 1 020 in the aspirin group, which corresponds to a relative reduction in the risk of 9% compared to aspirin. This means that fewer patients will experience new ischemic events when treated with Iscover than patients treated with aspirin. In other words, about 10 out of 1,000 patients will not undergo a new ischemic event two years after starting therapy with Iscover instead of aspirin.
In acute coronary syndrome without ST-segment elevation, the overall relative reduction in the risk of an event compared to placebo was 20%. There was also a reduction in patients who were implanted with a stent. In "ST-segment elevation myocardial infarction, the number of patients treated with Iscover who experienced an event was lower than that of patients who received placebo (262 versus 377 in CLARITY and 2 121 versus 2 310 in COMMIT ) This showed that Iscover reduces the risk of an event.
What is the risk associated with Iscover?
The most common side effects with Iscover (seen in 1 to 10 patients in 100) are hematoma (collection of blood under the skin), epistaxis (nosebleed), gastrointestinal bleeding (bleeding in the stomach or intestines ), diarrhea, abdominal pain (stomach pain), dyspepsia (heartburn), bruises and bleeding at the injection site. For the full list of side effects reported with Iscover, see the package leaflet.
Iscover must not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. It must not be used in patients with severe liver problems or diseases that can cause bleeding. For the full list of restrictions, see the Package Leaflet.
Why has Iscover been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Iscover's benefits are greater than its risks in preventing atherothrombotic events in adults. The committee therefore recommended the granting of a marketing authorization for Iscover.
Other information about Iscover:
On 15 July 1998, the European Commission granted Bristol Myers Squibb Pharma EEIG a "Marketing Authorization" for Iscover valid throughout the European Union. The "Marketing Authorization" was renewed on 15 July 2003 and the July 15, 2008.
For the full version of Iscover's EPAR click here.
Last update of this summary: 09-2009.
The information on Iscover - clopidogrel 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.
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