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Bleeding Time Unaffected by Addition of Cilostazol to Aspirin or Clopidogrel in Peripheral Arterial Disease Patients: Presented at SVMB

By Ed Susman

CHICAGO, IL -- June 10, 2003 -- The addition of the drug cilostazol, indicated for treatment of intermittent claudication symptoms caused by peripheral artery disease, doesn't appear to increase risk of bleeding in those patients taking aspirin or clopidogrel for coronary artery disease.

"From these studies it looks like there is no increased risk of bleeding by adding cilostazol to patients' therapy," said Doug Wilhite, MD, a fellow in vascular surgery at Temple University School of Medicine, in Philadelphia, Pennsylvania. Dr. Wilhite presented the findings in a poster presentation here on June 6^th at the 14^th Annual Meeting of the Society for Vascular Medicine and Biology.

Dr. Wilhite and his colleagues recruited 22 patients, with a mean age 65.8 years, who were diagnosed with peripheral artery disease. They tested the patients' bleeding times and also tested their blood for factors relating to platelet aggregation. They scrutinised relationships between their baseline bleeding and platelet characteristics and how the patients responded to therapy with aspirin, clopidogrel and cilostazol alone and in various combinations.

While aspirin and clopidogrel appeared to increase bleeding times and influenced platelet aggregation in vitro, the addition of cilostazol did not significantly change those figures, Dr. Wilhite said.

Bleeding time for clopidogrel alone averaged about 10.2 minutes, a significant increase from the baseline average of 4.5 minutes. Adding aspirin increased the bleeding time to an average of 17.4 minutes, significantly higher than both baseline and clopidogrel alone. But when cilostazol was added to the combination, bleeding time increased to 19.9 minutes, not statistically different from the aspirin-clopidogrel combination.

"This is an important study," said Michael Jaff, MD, the new president of the Society for Vascular Medicine and Biology and director of vascular medicine at Lenox Hill Hospital, in New York. "I and other doctors have been treating patients with this combination for some time."

"There is a fear among many doctors that if they combine these agents there will be bleeding problems," he said, noting that while cilostazol treats the symptoms of peripheral artery disease, clopidogrel and aspirin are primarily used to reduce the risks of complications of atherosclerosis, such as stroke or heart attack.

In Dr. Wilhite's study, none of the patients who received the triple combination developed bleeding problems, and Dr. Jaff said he has not encountered any such bleeding episodes among his patients. However, both doctors said a larger prospective study would be required to determine if there is a long-term risk.

"This study is reassuring for physicians," said Mark Creager, MD, director of the vascular centre at Brigham and Women's Hospital and an associate professor of medicine at the Harvard Medical School, in Boston, Massachusetts. He noted that aside from cilostazol there are no effective agents for treatment of the symptoms of intermittent claudication.

Regarding his study, Dr. Wilhite said, "These observations give insight into the clinical results observed in large randomised trials of platelet inhibition in patients with cardiac and vascular disease."

The study was supported by Otsuka America Pharmaceuticals, in Rockville, Maryland.


[Study title: Platelet Function Response to Single and Multiple Platelet Inhibitors in PAD Patients: A Prospective Study. Abstract P13]

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