Magazine article Drug Topics

Drug Offers Relief for Patients with Painful Leg Ailment

Magazine article Drug Topics

Drug Offers Relief for Patients with Painful Leg Ailment

Article excerpt

Angina of the legs is what some clinicians call it. An aching, cramping, crippling sensation felt in the legs with each trying step is how patients describe it. The disabling condition in question is intermittent claudication (IC), a symptom of _ peripheral arterial disease that until now was treated with limited pharmacologic agents that produced variable outcomes.

Recently, Pletal (cilostazol) phosphodiesterase (PDE) III inhibitorwas approved for the reduction of the symptoms of IC, as measured by increased walking distance. Manufactured by Otsuka Pharmaceuticals, the agent is the first compound in 15 years to gain the indication and join Trental (pentoxifylline)-the only other marketed drug used specifically for the condition.

Although cilostazol's exact mechanism of action is not fully understood, it is believed that the drug improves IC symptoms through inhibition of PDE Ill-an effect that results in decreased platelet aggregation, increased vasodilation, and in vitro inhibition of smooth muscle proliferation.

"The role of cilostazol is to allow people to walk farther and with less pain in their legs," declared William Hiatt, M.D., professor of medicine at the University of Colorado, Health Sciences Center, and executive director of the Colorado Prevention Center.

And indeed, the new drug was shown in clinical trials to improve maximum walking distance on a treadmill, pain-free walking distance, and other efficacy endpoints used to assess improvement, such as the walking impairment questionnaire. Specifically, IC patients treated with cilostazol for 24 weeks increased their walking distance by 106 meters (345 ft.) more than those taking placebo. Effects were seen at the first observation point of two to four weeks after starting therapy

While cilostazol has certainly been shown to alleviate patients' painful IC symptoms, its ability to reduce progression of the condition is still unclear. As Hiatt noted, "Cilostazol does seem to improve blood flow in the legs, but there is no current evidence indicating that it alters the long-term course of the disease."

Bill Forbes, Pharm.D., group leader of clinical operations at Otsuka, did refer to limited data from Asia-where the drug has been in use for some time-suggesting that cilostazol may have some properties that may affect the progression of IC. …

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