A Comparison of Cilostazol and Pentoxifylline for Treating Intermittent Claudication - Cilostazol and Pentoxifylline for Treating Intermittent Claudication


A Comparison of Cilostazol and Pentoxifylline for Treating Intermittent Claudication.


The purpose of this study was to compare the relative efficacy and safety of the cilostazol, a phosphodiesterace inhibitor, and pentyoxifylline for calf claudication.

Study Design

Study Design:

Patients Enrolled: 698

Drug/Procedures Used:

A randomized double-blind, placebo-controlled multicenter trial of 698 patients with stable moderately limiting claudication and an ankle/brachial index /= 10 mm Hg drop 60 seconds post exercise or a >/= 20 mm Hg decrease post exercise were randomized to one of three therapies: 24 weeks of cilostazol (100mg twice daily with a placebo tablet), pentoxifylline (400 three times daily), or three matching placebos. Measures of results included maximal walking distance on standardized treadmill tests at 4-week intervals, pain-free walking distance, resting Doppler limb pressures, and standardized quality-of-life surveys.

Principal Findings:

Mean maximal walking distance on cilostazol was significantly greater than pentoxifylline or placebo at each visit. After 24 weeks of treatment, the walking distance increased by an average of 107 meters (54% increase from baseline), which was significantly greater than pentoxifylline and placebo-treated groups who each increased by 65 meters (about 30% more than baseline). There was also a significant increase in pain-free walking distance with cilostazol compared to pentoxifylline and placebo, but the differences were more modest. A very small increase in mean ankle/brachial index (0.05) occurred after 24 weeks of cilostazol. None of the treatments affected the quality-of-life scores. Side effects attributable to cilostazol included headache, palpitations, and diarrhea. Cilostazol was significantly better than pentoxifylline or placebo for increasing total and pain-free walking distance in intermittent claudication but was associated with a greater frequency of minor side effects.


Cilostazol (Pletal™) is the first drug to demonstrate a clear benefit for intermittent claudication. It is a modest vasodilator, inhibits platelet aggregation, and has a beneficial effect on lipids. The value of cilostazol in comparison to aggressive lipid management combined with exercise rehabilitation is not known.


1. Dawson DL, Cutler BS, Hiatt WR, et al. Am J Med 2000;109:523-30.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Lipid Metabolism, Exercise

Keywords: Intermittent Claudication, Ankle Brachial Index, Diarrhea, Lipids, Pentoxifylline, Tetrazoles, Headache, Vasodilator Agents, Peripheral Vascular Diseases, Walking, Platelet Aggregation, Exercise Test, Phosphodiesterase 3 Inhibitors

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