Effect of cilostazol in patients with intermittent claudication: a randomized, double-blind, placebo-controlled study.
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.
Strandness
D Eugene
DE
University of Washington Medical Center, Seattle, WA, USA.
Dalman
Ronald L
RL
Panian
Steve
S
Rendell
Marc S
MS
Comp
Philip C
PC
Zhang
Peter
P
Forbes
William P
WP
D000328:Adult; D000368:Aged; D000077407:Cilostazol; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000188:drug therapy; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016138:Walking
D010726:Phosphodiesterase Inhibitors; D013777:Tetrazoles; D014665:Vasodilator Agents; D000077407:Cilostazol