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Effect of Cilostazol in Patients with Intermittent Claudication: A Randomized, Double-Blind, Placebo-Controlled Study

University of Washington Medical Center, Seattle, WA

Ronald L. Dalman, MD

Stanford University/VA Palo Alto Health Care System, Palo Alto, CA

Steve Panian, MD

Kaiser Permanente, Denver, CO

Marc S. Rendell, MD

Creighton University, Omaha, NE

Philip C. Comp, MD, PhD

Oklahoma Health Sciences, Oklahoma City, OK

Peter Zhang, PhD

William P. Forbes, PharmD

Otsuka America Pharmaceuticals, Inc, Rockville, MD

A multicenter, double-blind, randomized, placebo-controlled, parallel study was conducted to compare the efficacy and safety of cilostazol 100 mg and 50 mg, both administered twice daily, with that of placebo in patients with moderately severe intermittent claudication (IC) secondary to peripheral arterial disease. A total of 394 subjects 40 years of age or older with chronic, stable, symptomatic IC received cilostazol 100 mg twice daily, 50 mg twice daily, or placebo for 24 weeks. Subjects receiving cilostazol 100 mg twice daily experienced a 21% net improvement in maximal walking distance (MWD) compared with placebo subjects (p = 0.0003) and a 22% net improvement in distance walked to the onset of symptoms (PFWD) (p = 0.0015). Subjects who received cilostazol 50 mg twice daily also benefited from therapy, but not to a statistically significant degree (7% and 11% improvement in MWD and PFWD, respectively). Quality-of-life and functional status assessments corroborated these objective results. Cilostazol, in particular 100 mg twice daily, significantly improves symptoms in patients with IC.

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