Remarquez la dose utilisée: clopidogrel 75 mg bid
 
Alain

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Sent: 5 novembre 2008 06:50
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Subject: InfoPOEM: Aspirin + dipyridamole = clopidogrel for recurrent stroke
prevention (PROFESS)


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Aspirin + dipyridamole = clopidogrel for recurrent stroke prevention
(PROFESS)

Clinical question 
What is the best approach to the prevention of recurrent stroke?

Bottom line 
Aspirin plus dipyridamole is similarly effective to clopidogrel for the
prevention of recurrent stroke. The risk of intracerebral hemorrhage is
slightly lower with clopidogrel, and headache is more common with aspirin
plus dipyridamole. (LOE =  <http://mailer.cma.ca/t/3885065/234493/102001/0/>
1b)

Reference 
Sacco RL, Diener HC, Yusuf S, et al, for
<http://mailer.cma.ca/t/3885065/234493/2583001/0/> the Prevention Regimen
for Effectively Avoiding Second Strokes (PRoFESS) study group. Aspirin and
extended-release dipyridamole versus clopidogrel for recurrent stroke. N
Engl J Med 2008;359(12):1238-1251. 

Study design 
Randomized controlled trial (double-blinded)

Funding
Industry

Allocation
Concealed 

Setting
Outpatient (any) 


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Synopsis 
Antiplatelet agents such as aspirin, clopidogrel, and aspirin plus
extended-release dipyridamole (APERD) all reduce the risk of recurrent
stroke. Direct comparisons have shown small benefits of both APERD and
clopidogrel over aspirin alone, while aspirin plus clopidogrel is no more
effective and increases the risk of bleeding. Researchers recruited 20,332
patients older than 55 years with an ischemic stroke in the previous 90
days; they also enrolled patients aged 50 years to 54 years or within 90
days to 120 days if they also had at least 2 additional vascular risk
factors. Patients were randomly assigned to receive aspirin 25 mg plus
dipyridamole 200 mg twice daily or clopidogrel 75 mg twice daily and were
followed up for a mean of 2.5 years. This was a 2x2 factorial design, so
patients were also assigned to telmisartan or placebo, but those results are
not reported in this article. The mean age of participants was 66 years, 36%
were women, and 58% were white. The primary outcome was recurrent stroke as
adjudicated by an independent monitoring team. The analysis was by intention
to treat, and this was a noninferiority trial (ie, they were trying to prove
that APERD was at least as good as clopidogrel, not that it was better).
This was the case, as there was no difference between groups in the primary
outcome of recurrent stroke (9.0% receiving APERD, 8.8% receiving
clopidogrel), in all-cause mortality (7.3% vs 7.4%), or in a composite
outcome of stroke, myocardial infarction, or vascular death (13.1% for both
groups). Major hemorrhage was slightly more common in the APERD group (4.1%
vs 3.6%; P = .05; number needed to treat to harm [NNTH] = 200 over 2.5
years), as was intracranial hemorrhage (1.4% vs 1.0%; NNTH = 250 over 2.5
years). Headache was a more common side effect among patients taking APERD
than among those taking clopidogrel (30% vs 7%), and patients taking APERD
were more likely to discontinue the study medication than were patients
taking clopidogrel (5.9% vs 0.9%; NNTH = 20).

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