PLAVIX (clopidogrel), platelet aggregation inhibiting drug

Insufficient clinical benefit in combination with aspirin in the prevention of atherothrombotic and thromboembolic events in atrial fibrillation

• PLAVIX 75 mg, film-coated tablet, has a new Marketing Authorisation in combination with aspirin in the prevention of atherothrombotic and thromboembolic events secondary to atrial fibrillation (AF) associated with at least one risk factor for vascular events, in patients who cannot be treated by a vitamin K antagonists (VKAs) and who have a low risk of bleeding. 
• The clopidogrel/aspirin combination was less effective than VKA treatment in the prevention of major cardiovascular events.
• The benefit of a double platelet anti-aggregation by clopidogrel and aspirin compared to aspirin alone has not been demonstrated.
• The addition of clopidogrel reduced the risk of ischaemic stroke, without demonstrating benefit in the reduction of myocardial infarcts or systemic embolisms, or total or cardiovascular mortality. Major bleeding was more common in the clopidogrel + aspirin group (especially intracranial haemorrhage), as well as minor bleeding.