Cilostazol has beneficial effects in treatment of intermittent claudication: results from a multicenter, randomized, prospective, double-blind trial.
BACKGROUND
Cilostazol is a new phosphodiesterase inhibitor that suppresses platelet aggregation and also acts as a direct arterial vasodilator. This prospective, randomized, placebo-controlled, parallel-group clinical trial evaluated the efficacy of cilostazol for treatment of stable, moderately severe intermittent claudication.


RESULTS
Study inclusion criteria included age > or =40 years, initial claudication distance (ICD) on treadmill (12.5% incline, 3.2 km/h) between 30 and 200 m, and confirmation of diagnosis of chronic lower-extremity arterial occlusive disease. After stabilization and single-blind placebo lead-in, 81 subjects (62 male, 19 female) from 3 centers were randomized unequally (2:1) to 12 weeks of treatment with cilostazol 100 mg PO BID or placebo. Primary outcome measures included ICD and maximum distance walked (absolute claudication distance, or ACD). Secondary outcome measures included ankle pressures, subjective assessments of benefit by patients and physicians, and safety. Treatment and control groups were similar with respect to age, severity of symptoms, ankle pressures, and smoking status. Statistical analyses used intention-to-treat analyses for each of 77 subjects who had > or =1 treadmill test after initiation of therapy. Comparisons between groups were based on logarithms of ratios of ICD and ACD changes from baseline using ANOVA test at last treatment visit. The estimated treatment effect showed a 35% increase in ICD (P<0.01) and a 41% increase in ACD (P<0.01). There was no significant change in resting or postexercise ankle/brachial indexes. Patients' and physicians' subjective assessments corroborated the measured improvements in walking performance observed in the cilostazol-treated group.


CONCLUSIONS
Cilostazol improved walking distances, significantly increasing ICD and ACD. The data suggest cilostazol is safe and well tolerated for the treatment of intermittent claudication.
Dawson
D L
DL
Department of Surgery, University of Washington, Seattle, USA. dawson@whmc.af.mil
Cutler
B S
BS
Meissner
M H
MH
Strandness
D E
DE
D000328:Adult; D000368:Aged; D001161:Arteriosclerosis / Q000150:complications; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D000077407:Cilostazol; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D007511:Ischemia; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D016037:Single-Blind Method; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014280:Triglycerides / Q000097:blood; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016138:Walking
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D014280:Triglycerides; D014665:Vasodilator Agents; D002784:Cholesterol; D000077407:Cilostazol