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| |  Pletal (Cilostazol) More Effective In Relieving Leg Pain Than Trental (Pentoxifylline) ROCKVILLE, MD and PEAPACK, NJ -- October 27, 2000 -- A newly published study shows that Pletal® (cilostazol) Tablets enables people with the debilitating leg pain associated with intermittent claudication to walk nearly twice as far as patients taking either Trental® (pentoxifylline), the only other medication currently available for the condition, or placebo. The study of nearly 700 seniors is published in the November 1 issue of The American Journal of Medicine. The results showed that only Pletal significantly increased walking distances compared with placebo. Patients taking Pletal were able to walk farther before the onset of pain and before the symptoms stopped them. Patients in the group treated with the drug walked significantly farther than those in the other two groups at four weeks, and this difference increased throughout the study. After 24 weeks, patients taking Pletal increased their maximal walking distance by an average of 117 yards over baseline - more than the length of a football field. In contrast, patients in the study taking Trental showed no improvement over placebo. Patients taking Trental or placebo increased their walking distance by an average of 70 yards. Maximal walking distance is the distance patients could walk until they felt they could no longer continue. "To healthy people, the ability to walk the length of a football field may not seem important," says Jeffrey Borer, M.D., Chief, Division of Cardiovascular Pathophysiology, New York Presbyterian Hospital - New York Weill Cornell Center. "However, to patients with intermittent claudication, it can mean the difference between being homebound and doing daily activities such as grocery shopping." Intermittent claudication affects an estimated four million Americans ages 55 and older. The condition occurs when fatty deposits build up in the leg arteries, restricting oxygen-rich blood flow to the muscles. The result is painful cramps in the calf, buttock or thigh muscles that come on during exercise such as walking, but go away with rest. Intermittent claudication is often the only symptom of peripheral arterial disease - hardening of arteries in the legs - which, in turn, is a significant risk factor for heart attack and stroke among the elderly. "Increasingly, the data suggest that Pletal is the preferred medication for relieving the pain of intermittent claudication," says Dr. Borer. An estimated 75 percent of patients with intermittent claudication go undiagnosed, in part because they think leg pain is a natural consequence of aging. "Patients now have more reason to discuss their leg pain with their doctors." The randomized, double-blind, placebo-controlled study of 698 patients was conducted at 54 outpatient vascular clinics across the nation. Efficacy was assessed at baseline and four-week intervals for 24 weeks by measuring maximal walking distance on a treadmill with an increasing incline. Pletal was generally well tolerated. The most commonly occurring side effects in the active treatment groups were headache (28 percent), diarrhea (19 percent), and palpitation (17 percent) in the patients receiving Pletal, and pain (16 percent), pharyngitis (14 percent), and headache (11 percent) in patients receiving Trental. There was no significant difference in the incidence of serious side effects between the active treatment groups. An additional placebo-controlled clinical study comparing the relative efficacy of Pletal and Trental is now underway. Results are anticipated in 2001. Pletal became the first new therapy in 15 years indicated for patients with intermittent claudication when it was approved by the U.S. Food and Drug Administration (FDA) in January 1999. Pletal is indicated for the reduction of symptoms of intermittent claudication, as measured by increased walking distance. It is contraindicated in patients with congestive heart failure of any severity. Available in 50 mg and 100 mg tablets, the recommended dosage is 100 mg twice daily on an empty stomach. Standard medical management of patients with intermittent claudication includes smoking cessation, treatment of underlying risk factors for atherosclerosis progression (including high cholesterol, high blood pressure, and diabetes), evaluation for associated cardiovascular disease, exercise, and medication to minimize claudication.
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