PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Clopidogrel BMS?
Clopidogrel BMS is a medicine containing the active substance clopidogrel, available in the form of 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 administered to the following patient groups:
- patients who have had a recent myocardial infarction (heart attack); Clopidogrel BMS treatment 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 one area of the brain); treatment with Clopidogrel BMS 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 the medicine with aspirin (another medicine to prevent blood 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 are having a heart attack with "elevation of the ST segment" (an abnormal reading on the "ECG or electrocardiogram) when the doctor thinks that the treatment would be beneficial. It can also be used in patients who do not have this. abnormal ECG reading if you have unstable angina (a severe form of chest pain) or "non-Q-wave" myocardial infarction.
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 daily, 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 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).
In the body, Clopidogrel BMS is converted to the active form. For genetic reasons, some people 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 patients it has not yet been identified.
How does Clopidogrel BMS work?
The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation, which means that it helps prevent blood clots from forming. Blood clotting occurs when special blood cells, platelets, clump (stick together). to the 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 another heart attack or stroke.
How has Clopidogrel BMS been studied?
Clopidogrel BMS 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 was the number of patients experiencing a new "ischemic event" (heart attack, ischemic stroke or death) over a period of one to three years.
For acute coronary syndrome, Clopidogrel BMS was compared with placebo (a dummy treatment) in over 12,000 patients without ST segment elevation; of which 2 172 patients underwent stent implantation during the study (CURE study, lasted up to one year). Clopidogrel BMS was also compared with placebo in two studies in patients with ST-segment elevation: CLARITY, which involved more than 3,000 patients and lasted for up to eight days, and COMMIT in nearly 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 the acute coronary syndrome studies, 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 there were 939 events in the Clopidogrel BMS group and 1 020 in the aspirin group, which corresponds to a relative reduction in risk. 9% compared to aspirin, ie the number of patients experiencing new ischemic events 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 at a distance two years from the start of Clopidogrel BMS therapy compared to those treated with aspirin.
In the case of 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 underwent stent implantation. In the case of ST-segment elevation myocardial infarction, the number of patients treated with Clopidogrel BMS who reported events was lower than those treated with placebo (262 versus 377 in CLARITY and 2 121 versus 2 310 in COMMIT These results demonstrated 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 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 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, in patients with severe impairment
liver disease or with a disease that can cause bleeding. For the full list of restrictions, 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 a Marketing Authorization.
Other information about Clopidogrel BMS:
On 16 July 2008, the European Commission granted Bristol Myers Squibb Pharma EEIG a "marketing authorization" for Clopidogrel BMS, valid throughout the European Union, which was based on the "authorization granted to Iscover in 1998 (" consent informed").
For the full version of the Clopidogrel BMS EPAR, click here.
Last update of this summary: 09-2009.
The information on Clopidogrel BMS 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.
