The US experience with cilostazol in treating intermittent claudication.

The management of peripheral arterial disease (PAD) patients with intermittent claudication (IC) requires both aggressive risk management and targeted symptomatic therapies. The phosphodiesterase inhibitor cilostazol is the only US Food and Drug Administration (FDA) approved medication to demonstrate consistent benefits on both objective measures of exercise capacity and subjective measures of everyday functioning and quality of life. Pentoxifylline is also approved by the FDA for the treatment of claudication, but with less clinical benefit than cilostazol. This report will provide an overview of cilostazol's role in the treatment of patients with IC. Data will be presented regarding the safety and efficacy demonstrated by cilostazol in clinical trials, as well as the effects of risk-factor control, exercise therapy, revascularization, and experimental drugs on the treatment of claudication in the PAD population. Based on the available evidence, a comprehensive approach to claudication management is recommended.