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The
primary outcome analysis in CAPRIE was based on the composite end point of
MI, ischemic stroke, or vascular death among all randomized patients
(intent-to-treat analysis). Only the
first occurrence of these outcomes was counted. The total number of patients
randomized were 9599 for clopidogrel bisulfate and 9586 for aspirin.[1]
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Results
from the CAPRIE trial demonstrated that clopidogrel had a lower event rate
per year compared with aspirin, 5.32% vs 5.83%, respectively, which resulted
in an overall risk reduction of 8.7%[1] (P = 0.045)[2] vs aspirin. An
on-treatment analysis of the primary event cluster showed a relative risk
reduction of 9.4%[1] (P = 0.046).[3]
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Although
the statistical significance favoring clopidogrel bisulfate (Plavix®)
over aspirin was marginal (P = 0.045, based on overall incidence of
primary outcome events: 9.78% for clopidogrel vs 10.64% for aspirin), and
represents the result of a single trial that has not been replicated, the
comparator drug, aspirin, is itself effective (vs placebo) in reducing
cardiovascular events in patients with recent MI or stroke. Thus, the
difference between clopidogrel and placebo, although not measured directly,
is substantial.[2]
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The
cumulative risk curves separated early and continued to diverge during the
3-year follow-up period.[1]
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CAPRIE
Steering Committee. A randomised, blinded, trial of clopidogrel versus
aspirin in patients at risk of ischaemic events (CAPRIE). Lancet.
1996;348:1329-1339.
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Plavix®
(clopidogrel bisulfate) Prescribing Information.
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Data on
file, Sanofi-Synthelabo Inc.
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