Thursday, February 5, 2009

Aspirin alternative could benefit Chinese stroke patients

Medical Tribune July 2008 P9
David Brill

Cilostazol is as effective as aspirin at preventing stroke recurrence but carries a lower risk of brain bleeding events, according to the results of a pilot study published in The Lancet Neurology.

These findings suggest that the drug could be a safer alternative to aspirin for secondary stroke prevention, particularly in Chinese populations, which have high rates of hemorrhagic stroke and other bleeding events.

Lead author Dr. Yining Huang of the Peking University First Hospital in Beijing, said that cilostazol could be used routinely in future, but should only be given to patients at high risk of hemorrhage. He added that aspirin is more cost effective and should remain first-line treatment for the majority of patients.

The study also found that mild side effects such as headache, dizziness and palpitations were more common among patients taking cilostazol.

The researchers conducted a randomized double-blind trial comprised of 720 patients who had experienced an ischemic stroke within the past 6 months. Participants took aspirin (100 mg per day) or cilostazol (100 mg twice per day) for between 12 and 18 months. [Lancet Neurol 2008 Jun;7(6):494-499]

Over the study period seven brain bleeding events occurred in the aspirin group, compared to just one in the cilostazol group (P=.034).

Cilostazol also reduced the overall risk of stroke recurrence by 38.1 percent but this comparison was not statistically significant. The authors suggest that the small sample size and short follow-up duration meant that the study was underpowered to assess the relative efficacies of the two drugs.

Dr. Charles Siow, a consultant neurologist at the Siow Neurology Headache and Pain Centre in Singapore said: “If the study can be replicated and the efficacy confirmed in a larger study, cilostazol may be an option for stroke prevention.” Siow added that cilostazol, a phosphodiesterase 3 inhibitor, could replace aspirin in routine practice only if the issues of side effects and cost were resolved.

Stroke is a leading cause of death in China, and there is a high proportion of hemorrhagic
stroke. Research has demonstrated that stroke rates vary across different regions but are typically higher than in Western countries. [Stroke 2006 Jan;37(1):63-8]

A larger-scale multicenter trial comparing cilostazol with aspirin is already underway in Japan. Two thousand six hundred patients have been enrolled and are due to be followed up for between 1 and 5 years. Huang said that the interim results were “very positive.”

The trial is expected to finish in December this year and will be published in 2010.

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