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What is Clopidogrel BMS?
Clopidogrel BMS is a medicine that contains the active substance clopidogrel, available as pink tablets (round: 75 mg; oblong: 300 mg).
What is Clopidogrel BMS used for?
Clopidogrel BMS is used in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel BMS can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack); Clopidogrel BMS treatment can start in the period between a few days and 35 days after the infarction;
- patients who have had a recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain); treatment with Clopidogrel BMS may 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", to which the medicine should be administered with aspirin (another medicine to prevent the formation of clots), including patients who have been implanted with a stent (a tube inserted into an artery to prevent clogging). Clopidogrel BMS can be used in patients who have a heart attack with "ST-segment elevation" (an abnormal ECG reading or electrocardiogram) when the doctor thinks the treatment may 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 Clopidogrel BMS used?
The standard dose of Clopidogrel BMS is one 75 mg tablet once a day, with or without food. In acute coronary syndrome, Clopidogrel BMS is used together 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 a day for at least four weeks (in myocardial infarction with elevation of the ST segment) or up to 12 months (in the presence of a syndrome without elevation of the ST segment).
In the body, Clopidogrel BMS is converted to the active form. For genetic reasons, some individuals may not be able to convert Clopidogrel BMS 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 yet been identified.
How does Clopidogrel BMS work?
The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation, which helps prevent blood clots. Blood coagulation occurs when 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 another heart attack or stroke.
How has Clopidogrel BMS been studied?
Clopidogrel BMS was compared with aspirin in a study called CAPRIE comprising about 19, 000 patients who had recently had a heart attack or an ischemic stroke or who had established 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, Clopidogrel BMS was compared to a placebo (a dummy treatment) in over 12, 000 patients without an ST segment elevation; of which 2 172 patients underwent stent implantation during the study (CURE study, which lasted up to a year). Clopidogrel BMS was also compared with a placebo in two studies on patients with ST segment elevation: CLARITY, which involved more than 3, 000 patients and lasted up to eight days, and COMMIT performed on almost 46, 000 patients who received it Clopidogrel BMS, with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks. In studies of acute coronary syndrome, all patients also took aspirin and the main measure of effectiveness was the number of patients who reported an "event", such as a blocked artery, another heart attack or death, during of study.
What benefit has Clopidogrel BMS shown during the studies?
Clopidogrel BMS was more effective than aspirin in preventing new ischemic events. During the CAPRIE study 939 events were recorded in the group treated with Clopidogrel BMS and 1 020 in the group treated with aspirin, which corresponds to a relative reduction in risk of 9% compared with aspirin, ie the number of patients undergoing new events Ischemic is lower if they are treated with Clopidogrel BMS instead of aspirin. In other words, about 10 out of 1, 000 patients will avoid a new ischemic event two years after starting therapy with Clopidogrel BMS compared to those taking aspirin.
In the case of acute coronary syndrome without elevation of the ST segment, the overall relative risk reduction of one event compared to placebo was 20%. A reduction was also recorded in patients undergoing stent implantation. In the case of myocardial infarction with ST segment elevation, the number of patients treated with Clopidogrel BMS who reported events was lower than those treated with placebo (262 compared to 377 in the CLARITY study and 2 121 compared to 2 310 in the COMMIT study ). These results showed that Clopidogrel BMS reduces the risk of an event.
What is the risk associated with Clopidogrel BMS?
The most common side effects with Clopidogrel BMS (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 Clopidogrel BMS, see the Package Leaflet.
Clopidogrel BMS should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other substances, to patients with severe insufficiency
hepatic or with a disease that can cause bleeding. For the full list of limitations, see the package leaflet.
Why has Clopidogrel BMS been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS's benefits are greater than its risks for the prevention of atherothrombotic events in adults and therefore recommended that it be given marketing authorization.
More information on Clopidogrel BMS:
On 16 July 2008, the European Commission granted Clopidogrel BMS, valid throughout the European Union, a marketing authorization to Bristol Myers Squibb Pharma EEIG. This authorization was based on the authorization granted to Iscover in 1998 ("informed consent").
For the full EPAR of Clopidogrel BMS, click here.
Last update of this summary: 09-2009.
