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 cilostazol for preventing strokes are needed, Dr. William M. Stone said at the Vascular Annual Meeting. He and his associates looked at data collected in a postmarketing, safety study of cilostazol that compared the long-term effect of 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.
The Cilostazol: A Study on Long-Term Effects (CASTLE) study enrolled patients in 2001–2004. The results have not yet been published.
A total of 717 patients were randomized to a standard regimen with cilostazol and 718 to placebo. The average duration of treatment was 515 days. The average age of the patients was 66 years. The pattern of concomitant medication use and the prevalence of cerebrovascular risk factors were similar in both arms.
Forty-four placebo patients (6%) had cerebrovascular events, and 23 patients treated with cilostazol (3%) had cerebrovascular events. The difference in rate between the two groups was statistically significant, said Dr. Stone, who is a vascular surgeon at the Mayo Clinic in Scottsdale, Ariz.