One study, published in The New England Journal of Medicine (01/20/05), compared the use of aspirin combined with esomeprazole (Nexium) against the use of clopidogrel (the generic version of Plavix) combined with a placebo. The purpose of the study was to determine whether clopidogrel itself was a safer, more effective alternative to aspirin combined with a proton-pump inhibitor (Nexium) for patients with a higher risk of developing an ulcer.
Researchers found that 13 patients in the clopidogrel group suffered recurrent ulcer bleeding, compared to one person in the aspirin and esomeprazole group. Furthermore, three patients in the clopidogrel group suffered bleeding outside of the gastrointestinal tract; of those, two suffered intracranial hemorrhage and one person required a transfusion. None of the patients in the aspirin group suffered bleeding outside the gastrointestinal tract.
Finally, of the 12 patients who died during the study, eight patients were in the clopidogrel group (cause of death included myocardial infarction, heart failure, sepsis and intracranial hemorrhage). Four of the deaths were in the aspirin group (cause of death included myocardial infarction, cerebrovascular insufficiency and renal failure.)
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In 2006, a study published in The New England Journal of Medicine (04/20/06) found there was no significant benefit to treating patients with clopidogrel and aspirin, compared with giving the patients aspirin and a placebo. In fact, researchers found that patients who did not have symptoms of heart attack or stroke, the risk of death and moderate to severe bleeding increased when given clopidogrel. Furthermore, they found that there was, "no significant benefit associated with clopidogrel plus aspirin as compared with placebo plus aspirin in reducing the incidence of the primary end point of myocardial infarction, stroke or death from cardiovascular causes."