Cilostazol may be as effective as aspirin for secondary stroke prevention
Cilostazol may be as effective as, or superior to, aspirin for the prevention of secondary stroke, a study published online in Lancet Neurology (11 September 2010) confirms. The results may not be generalisable because the study only included individuals from East Asia and those with non-severe strokes.
A smaller study reported the same findings in 2008, but called for a larger, longer study.
In the present study, cilostazol was compared with aspirin to examine its safety and efficacy in around 3,000 Japanese patients with a history of non-cardioembolic ischaemic stroke.
After an average follow-up of around six months, the yearly rate of stroke was lower in the cilostazol group (2.76 per cent) than in the aspirin group (3.71 per cent) — a reduction in risk of stroke of 26 per cent compared with aspirin. In addition, haemorrhagic events occurred in fewer patients on cilostazol than on aspirin.
Because the study only included individuals from East Asia and those with non-severe strokes, the authors point out that the findings might not be generalisable.
But they add: “The results deserve validation in larger and more diverse study populations. The choice of the best antiplatelet drug for the secondary prevention of ischaemic stroke remains challenging, but the trial shows that there might be another promising pathway for the secondary stroke prevention beyond the protection provided by aspirin.” They suggest that because of the fewer haemorrhagic events in the cilostazol group, it could be useful in patients with an increased risk of haemorrhage.
Alison Warren, lead cardiac pharmacist at Brighton and Sussex University Hospitals NHS Trust, pointed out that the discontinuation rate due to adverse events with cilostazol, at 20 per cent, was much higher than with aspirin (12 per cent).
However, she believes that the study results are promising. “As long as the contraindications for cilostazol are taken into account, it is possible that this drug could offer an alternative option for patients who are unable to take aspirin due to the risk of bleeding events,” she said.
“Further research in a wider population would help to clarify the place of cilostazol in therapy and also to ascertain whether the benefits are purely attributable to the antiplatelet effects of cilostazol or perhaps in part to the effects on the vascular wall and endothelium (the so called plieotropic effects),” she added.
Study method and results
Nearly 3,000 patients with cerebral infarction from across Japan were randomised to receive 100mg of cilostazol twice daily or 81mg of aspirin daily for one to five years.
The primary endpoint was first occurrence of stroke (cerebral infarction, cerebral haemorrhage or subarachnoid haemorrhage).
The results from 2,672 of these individuals were analysed. Eighty-two people (2.76 per cent) in the cilostazol group and 119 people (3.71 per cent) in the aspirin group had a stroke (hazard ratio 0.743, 95 per cent confidence interval 0.564–0.981; P=0.0357).
Haemorrhagic events occurred in fewer patients on cilostazol than on aspirin (P=0.0004). Other side effects such as headache, diarrhoea, palpitation, dizziness, and tachycardia were more frequent in the cilostazol group.
The study was funded by Otsuka Pharmaceutical.
Citation: The Pharmaceutical Journal URI: 11025188
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