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Aspirin alone, aspirin plus dipyridamole, and clopidogrel are often prescribed for secondary prevention of stroke. Now, cilostazol (Pletal and generics) — a drug with antiplatelet and vasodilating properties that is FDA-approved only for treating intermittent claudication — enters the picture.
In a manufacturer-sponsored double-blind randomized trial conducted in Japan, 2757 people with recent noncardioembolic strokes received cilostazol (100 mg twice daily) or aspirin (81 mg daily). During mean follow-up of 29 months, the primary endpoint (recurrent cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage) occurred less commonly in the cilostazol group than in the aspirin group (6.1% vs. 8.9%; P=0.04). Bleeding events (intracranial hemorrhage or other hemorrhage that required hospitalization) also were less common with cilostazol (1.7% vs. 4.3%; P<0.001). Numerous adverse effects were more common with cilostazol than with aspirin (e.g., headache, diarrhea, palpitations, dizziness), which resulted in more cilostazol recipients than aspirin recipients withdrawing from the trial (20% vs. 12%).
Shinohara Y et al. Cilostazol for prevention of secondary stroke (CSPS 2): An aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol 2010 Oct; 9:959. (http://dx.doi.org/10.1016/S1474-4422(10)70198-8)
Comment
This study is the second comparison of cilostazol and aspirin for secondary prevention of stroke. The first was a Chinese trial in which cilostazol was not significantly better than aspirin; however, only 700 patients were treated for only 1 year (Lancet Neurol 2008; 7:494). In both trials, adverse effects were more common with cilostazol. Moreover, even generic cilostazol is expensive in the U.S. (at one local pharmacy, about $85 per month at 100 mg twice daily), and findings in Asian patients might not apply to other ethnic groups. In my view, cilostazol should not be a first-line treatment for secondary prevention of stroke until further data confirm its superiority to aspirin in diverse populations.