Evidence-based symptom relief of intermittent claudication: efficacy and safety of cilostazol

Intermittent claudication (IC) is a common, debilitating symptom of atherosclerotic peripheral arterial disease. There are two therapeutic objectives in patients with IC: relief of symptoms and secondary prevention of acute thrombotic complications. Among patients with Fontaine stage II disease, surgical revascularization for symptom relief is reserved for those in whom exercise/lifestyle modification and medical therapy has failed. To improve exercise tolerance in IC requires favourable alteration in the oxygen supply/demand relationship in the lower limb. Following the largest ever clinical trials programme in patients with IC, cilostazol, a phosophodiesterase III inhibitor, has been licensed for symptom relief in the UK. In double-blind, randomized, placebo-controlled trials involving over 2000 patients, cilostazal 100 mg b.d. produced significant and sustained improvements in pain-free and maximal walking distances as well as improved subjective assessments of quality of life. In particular, comparative studies with pentoxifylline (oxpentifylline) showed that cilostazol had significantly greater effects on functional outcome and exhibited good patient tolerance.