Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication.
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.
Thompson
Paul D
PD
Hartford Hospital, Hartford, Connecticut 06102, USA. pthomps@harthosp.org
Zimet
Richard
R
Forbes
William P
WP
Zhang
Peter
P
D000368:Aged; D008076:Cholesterol, HDL / Q000097:blood; D000077407:Cilostazol; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000097:blood / Q000188:drug therapy*; D008297:Male; D015337:Multicenter Studies as Topic; D010431:Pentoxifylline / Q000627:therapeutic use; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use; D016138:Walking
D008076:Cholesterol, HDL; D010726:Phosphodiesterase Inhibitors; D013777:Tetrazoles; D014280:Triglycerides; D014665:Vasodilator Agents; D000077407:Cilostazol; D010431:Pentoxifylline