Cilostazol, Decrease in Stroke Linked

BY MITCHEL L. ZOLER

BALTIMORE -- Treatment with the claudication drug cilostazol was linked to a significant drop in the rate of cerebrovascular events in a post hoc analysis of data collected from more than 1,400 patients with peripheral artery disease.

Further studies on the effect of cilostazol for preventing strokes are needed, Dr. William M. Stone said at the Vascular Annual Meeting.

The study used data from a postmarketing, safety study of cilostazol that compared the drug treatment with placebo in a randomized study of patients with intermittent claudication secondary to peripheral arterial disease. The study was sponsored by Otsuka, which markets cilostazol (Pletal). The drug was approved by the Food and Drug Administration in 1999 to treat claudication. Dr. Stone disclosed no financial relationships with Otsuka, but said that one of his associates who also worked on the analysis was a consultant to and received honoraria from Otsuka.

Cilostazol: A Study on Long-Term Effects (CASTLE) enrolled patients from May 2001 to November 2004. The study screened 1,899 patients and 1,439 were eligible to enroll. A total of 1,435 patients participated--717 were randomized to cilostazol and 718 received placebo. The average duration of treatment was 515 days. The average age of the patients was 66, and two-thirds were men. Concomitant medication use was similar in the two treatment arms, as was the prevalence of cerebrovascular risk factors.

There were 66 cerebrovascular events (4.6%) during treatment; 90% were ischemic events and the remaining 10% were hemorrhagic. This included strokes, transient ischemic attacks, and need for carotid revascularization. Forty-four placebo patients (6%) had cerebrovascular events, and 23 patients treated with cilostazol (3%) had cerebrovascular events, a significant difference, said Dr. Stone, a vascular surgeon at the Mayo Clinic in Scottsdale, Ariz