Peripheral arterial disease affects 20% of people over 70 years of age and 4% to 12% of the population aged 55 to 70 years. Approximately 40% of those affected with peripheral arterial disease commonly complain of intermittent claudication. Intermittent claudication is characterised by pain in the legs or buttocks that occurs with exercise and which subsides with rest. Despite the relatively benign prognosis for the affected leg, the symptoms of intermittent claudication are an indicator for the development of systemic atherosclerosis. Compared with age-matched controls, people with intermittent claudication have a three- to six- fold increased chance of dying as a result of cardiovascular events.
The majority of patients with intermittent claudication are treated with best medical management. Symptoms of intermittent claudication, walking distance, and quality of life can be improved by risk factor modification, which includes stopping smoking and a structured exercise program. Further cardiovascular risk modification includes treatment for hypertension, diabetes and cholesterol reduction. Antiplatelet treatment is given to reduce the risk of cerebrovascular and coronary events and is effective in the long-term secondary prevention of vascular events in people at high risk of vascular disease, including those who have had ischaemic stroke or acute myocardial infarction. However, antiplatelet therapy has not been shown to influence claudication distance (i.e. the distance walked before the onset of pain). In practice, compliance with best medical treatment is poor and most people continue to have symptoms of intermittent claudication. Until recently there have been three options; supervised exercise, angioplasty or bypass surgery. Compliance with supervised exercise is poor; the long-lasting effect of angioplasty is unproven and surgery carries significant morbidity and mortality. Many pharmacological agents have been advocated for treating intermittent claudication but until recently none have gained acceptance. Cilostazol has recently been approved for the treatment of intermittent claudication. Cilostazol has been shown to be of benefit in improving pain-free walking distance in people with intermittent claudication. There are no data on whether it results in a reduction of cardiovascular events.