SAN ANTONIO—Patients receiving the antiplatelet agent cilostazol were 25.7% less likely to have a secondary stroke than those taking aspirin, Yukito Shinohara, MD, reported at the 2010 International Stroke Conference. This is the first study to demonstrate that cilostazol significantly reduces the risk of recurrent ischemic stroke and the incidence of serious cerebral hemorrhage, compared with aspirin.
In the double-blind multicenter study of 2,672 patients in Japan who had had a cerebral infarction within the previous six months, Dr. Shinohara and colleagues randomly assigned subjects to receive either 100 mg of cilostazol twice a day or 81 mg of aspirin once a day. Patients remained on the medication for one to five years between December 2003 and December 2008.
Safer and Better
For the primary end point of occurrence of symptomatic stroke, including cerebral infarction, intercerebral hemorrhage, or subarachnoid hemorrhage, during the treatment period, cilostazol showed superiority over aspirin (hazard ratio [HR], 0.743). Of the 1,337 patients in the cilostazol group, 82 strokes occurred, with two fatalities, compared with 119 strokes and three fatalities among the 1,335 patients in the aspirin group.
“These results establish noninferiority of cilostazol over aspirin for secondary prevention of stroke,” said Dr. Shinohara, who heads the Neurology Department at Tachikawa Hospital in Tokyo. “Furthermore, it was shown that cilostazol was statistically significantly more effective than aspirin in preventing recurrent stroke.”
Cilostazol was also found to be superior over aspirin for the secondary end point cluster of recurrence of symptomatic cerebral infarction, occurrence of ischemic cerebrovascular event, death from any cause or cluster of stroke, transient ischemic attack, angina pectoris, myocardial infarction, heart failure, or hemorrhage (HR, 0.799) and the safety end point of bleeding events, which include cerebral hemorrhage, subarachnoid hemorrhage, and bleeding requiring hospitalization (HR, 0.458).
Costs Versus Benefits
Cilostazol, marketed under the brand name Pletal by Otsuka America Pharmaceutical, Inc, in Rockville, Maryland, and FDA approved to treat intermittent claudication, has a weaker antiplatelet action than aspirin or clopidogrel, which may explain the reduced risk of hemorrhage, Dr. Shinohara noted.
“This drug not only has antiplatelet effects, but also some other action [due to its] greater trophic effects that improves the endothelial dysfunction of the distal region and [may] increase the prevention of stroke,” he said.“So this kind of modular effect may be the reason why this drug has fewer hemorrhagic side effects.”
However, cilostazol costs almost four times more than aspirin, Dr. Shinohara pointed out. “That’s a big problem,” he said. “Aspirin is a very good drug and a very cheap drug. We are trying to do the cost-effective study now.”
—Rebecca K. Abma