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19185 patients,with more than 6300 in each of the clinical subgroups,were recruited over 3 years,with a mean follow-up of 1.91 years.There were 1960 first events included in the outcome cluster in which an intention-to- treat analysis showed that patients treated with clopidogrel had an annual 5.32%risk of ischaemic stroke,myocardial infarction,or vascular death compared with 5.83%with aspirin.These rates reflect a statistically significant(p=0.043)relative-risk reduction of 9.4%.There were no major differences in terms of safety.Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash(0.26%vs 0.10%),diarrhoea(0.23%vs 0.11%),upper gastrointestinal discomfort(0.97%vs 1.22%),intracranial heamorrhage(0.33%vs 0.47%),gastrointestinal haemorrhage(0.52%vs 0.72%),respectively.There were 10(0.10%)patients in the clopidogrel group with significant reductions in neutrophils(<1.2 x10000000000/L)and 16(0.17%in the aspirin group).Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischamic stroke, myocardial infarction,or vascular death.The overall safety profile of clopidogrel is at least as good as that of medium dose aspirin. |
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