The Pharmaceutical Journal
Vol 280 No 7501 p560
10 May 2008

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Cilostazol as effective as aspirin

Cilostazol, an investigational antiplatelet drug, is as effective as aspirin for the secondary prevention of ischaemic stroke and is associated with fewer bleeding events, according to a study in China (published online in The Lancet Neurology, 5 May 2008).

However, a larger study is needed to confirm the findings, say the researchers.

Cilostazol is a phosphodiesterase-3 inhibitor and so works via a different mechanism to aspirin. It prevents inactivation of the intracellular second messenger cyclic AMP and irreversibly inhibits platelet aggregation and vasodilation.

The study included 720 patients who had experienced an ischaemic stroke within the past one to six months. Participants were randomised to receive cilostazol 100mg twice a day or aspirin 100mg a day for 12 to 18 months. The primary endpoint was recurrence of stroke — ischaemic, haemorrhagic or subarachnoid.

The researchers found no difference in the recurrence of stroke between the two groups (12 patients in the cilostazol group versus 20 in the aspirin group, hazard ratio 0.62, 95 per cent confidence interval 0.3–1.26; P=0.185).

However, more patients in the aspirin group experienced symptomatic cerebral haemorrhage (five versus one) and asymptomatic cerebral haematoma (four versus one). Bleeding events occurred more frequently in the aspirin group than in the cilostazol group (seven versus one; P=0.034).

The researchers say that cilostazol had similar effects to aspirin in the prevention of stroke during the first six months after starting treatment but was more effective after that. They believe that the difference did not reach statistical significance due to the small sample size and short follow-up period of the study.

The incidence of cerebral haemorrhage and other bleeding events is higher in the Chinese population than in other ethnic groups so the prevention of cerebral haemorrhage is crucial in preventing stroke in these patients, the researchers note.

They conclude that the lower rates of ischaemic and haemorrhagic stroke in the cilostazol group suggest that it might be a more effective and safer alternative to aspirin for Chinese patients with ischaemic stroke. However, phase III trials are needed to confirm this result, they add.

In an accompanying comment, Graeme Hankey, department of neurology, Royal Perth Hospital, Australia, says: “The implications of these results for clinicians are that they offer hope for a safer antiplatelet drug that is at least as effective as aspirin for use in patients with ischaemic stroke.”