What is Iscover?
Iscover is a medicine that contains the active substance clopidogrel. It is available as pink tablets (round: 75 mg; oblong: 300 mg).
What is Iscover used for?
Iscover is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Iscover can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Iscover can start in the period between a few days and 35 days after the heart attack;
- recent patients with ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Iscover can start between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood circulation in the arteries);
- patients suffering from a disorder known as "acute coronary syndrome", which should be administered with aspirin (another medicine to prevent the formation of clots), including patients who have been implanted with a stent (a small tube inserted into an artery to prevent it obturation). Iscover can be used in patients who have a heart attack with "ST segment elevation" (an abnormal ECG reading or electrocardiogram) when the doctor believes the treatment can be beneficial. It can also be used in patients who do not have this abnormal ECG reading, when suffering from unstable angina (a severe form of chest pain) or myocardial infarction "without Q waves".
The medicine can only be obtained with a prescription .
How is Iscover used?
The standard dose of Iscover is one 75 mg tablet once a day with or without food. In acute coronary syndrome, Iscover is associated with aspirin, and treatment generally 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 a day for at least four weeks (in myocardial infarction with ST segment elevation) or up to 12 months (in the presence of ST-segmentless elevation syndrome).
Within the organism Iscover is converted into the active form. For genetic reasons, some individuals may not be able to convert Iscover as effectively as other patients, which may 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 to prevent the formation of blood clots. The blood coagulates when some special blood cells, the platelets, aggregate (stick together). 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 and helping to prevent a recurrence of heart attacks or strokes.
What studies have been carried out on Iscover?
Iscover as an anticoagulant was compared with aspirin in a study called CAPRIE in about 19, 000 patients who had recently had a heart attack or an ischemic stroke, or who had confirmed peripheral arterial disease. The main measure of effectiveness was the number of patients who underwent a new "ischemic event" (heart attack, ischemic stroke or death) over a period of one to three years.
With regard to acute coronary syndrome, Iscover was compared to a placebo (a dummy treatment) in a study conducted on over 12, 000 patients without elevation of the ST segment, to 2 172 of whom a stent was implanted in the course of study (CURE study, lasted up to one year). Iscover was also compared with a placebo in two studies involving patients with ST segment elevation: CLARITY, which involved more than 3, 000 patients and lasted 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 studies of acute coronary syndrome, all patients also took aspirin and the main indicator of effectiveness was based on the number of subjects reporting an "event", for example an arterial block or another infarct, or who had died during the course of study.
What benefit has Iscover shown during the studies?
Iscover was more effective than aspirin in preventing new ischemic events. During the CAPRIE study, 939 events were recorded in the group treated with Iscover and 1 020 in the group treated with aspirin, which corresponds to a relative risk reduction of 9% compared with aspirin. This means that fewer patients will experience new ischemic events if they are treated with Iscover compared to patients treated with aspirin. In other words, about 10 of 1 000 patients will not undergo a new ischemic event two years after starting Iscover therapy instead of aspirin.
In acute coronary syndrome without ST segment elevation, the overall relative risk reduction of one event compared with placebo was 20%. A reduction was also recorded in patients who had a stent implanted. In myocardial infarction with ST-segment elevation, the number of patients treated with an Iscover event was lower than that of patients receiving placebo (262 versus 377 in the CLARITY study and 2 121 versus 2 310 in the COMMIT study ). 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 between 1 and 10 patients in 100) are hematoma (collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or intestines ), diarrhea, abdominal pain (stomach ache), dyspepsia (heartburn), bruises and bleeding at the injection site. For the full list of all side effects reported with Iscover, see the Package Leaflet.
Iscover should 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 disorders or diseases that can cause bleeding. For the complete list of limitations, 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 for the prevention of atherothrombotic events in adults. The committee therefore recommended the granting of the marketing authorization for Iscover.
Other information about Iscover:
On 15 July 1998, the European Commission issued a marketing authorization valid for Iscover for Bristol throughout the European Union to Bristol Myers Squibb Pharma EEIG. The marketing authorization was renewed on 15 July 2003 and 15 July 2008.
The full EPAR for Iscover can be found here.
Last update of this summary: 09-2009.
