Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication

Am J Cardiol. 2002 Dec 15;90(12):1314-9. doi: 10.1016/s0002-9149(02)02869-2.


We examined the effect of cilostazol, a type III phosphodiesterase inhibitor, on pain-free and maximal walking distance and quality of life measures. The present study examined adverse effects in 2,702 patients with stable, moderate to severe claudication enrolled in 8 randomized, double-blind, placebo-controlled trials. Treatment duration ranged from 12 to 24 weeks. Cilostazol therapy increased maximal and pain-free walking distances by 50% and 67%, respectively. In subgroup analysis, cilostazol increased pain-free and maximal walking distance similarly in men and women, in older (>/=65 years) and younger patients, and in patients with and without diabetes. Quality-of-life assessments revealed enhanced scores for physical well-being. Cilostazol-treated patients reported a higher incidence of headache, bowel complaints, and palpitations than patients given placebos. Cilostazol decreased triglycerides by 15.8% and increased high-density lipoprotein cholesterol by 12.8%, but there were no deleterious effects on any hematologic or serum markers. We conclude that cilostazol significantly increases walking distance and quality-of-life measures in patients with claudication without major adverse effects.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cholesterol, HDL / blood
  • Cilostazol
  • Clinical Trials, Phase III as Topic
  • Double-Blind Method
  • Exercise Test
  • Female
  • Humans
  • Intermittent Claudication / blood
  • Intermittent Claudication / drug therapy*
  • Male
  • Multicenter Studies as Topic
  • Pentoxifylline / therapeutic use
  • Phosphodiesterase Inhibitors / adverse effects
  • Phosphodiesterase Inhibitors / therapeutic use*
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Treatment Outcome
  • Triglycerides / blood
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use
  • Walking


  • Cholesterol, HDL
  • Phosphodiesterase Inhibitors
  • Tetrazoles
  • Triglycerides
  • Vasodilator Agents
  • Cilostazol
  • Pentoxifylline