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 suppre sses platelet aggregation and also acts as a direct arterial vasodilat or. This prospective, randomized, placebo-controlled, parallel-group c linical trial evaluated the efficacy of cilostazol for treatment of st able, moderately severe intermittent claudication. Methods and Results -Study inclusion criteria included age greater than or equal to 40 yea rs, initial claudication distance (ICD) on treadmill (12.5% incline, 3 .2 km/h) between 30 and 200 m, and confirmation of diagnosis of chroni c 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 A CD). Secondary outcome measures included ankle pressures, subjective a ssessments of benefit by patients and physicians, and safety. Treatmen t and control groups were similar with respect to age, severity of sym ptoms, ankle pressures, and smoking status. Statistical analyses used intention-to-treat analyses for each of 77 subjects who had greater th an or equal to 1 treadmill test after initiation of therapy. Compariso ns between groups were based on logarithms of ratios of ICD and ACD ch anges from baseline using ANOVA test at last treatment visit. The esti mated 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' subj ective assessments corroborated the measured improvements in walking p erformance observed in the cilostazol-treated group. Conclusions-Cilos tazol improved walking distances, significantly increasing ICD and ACD . The data suggest cilostazol is safe and well tolerated for the treat ment of intermittent claudication.