Cilostazol has beneficial effects in treatment of intermittent claudication: Results from a multicenter, randomized, prospective, double- blind trial

David L Dawson, Bruce S. Cutler, Mark H. Meissner, D. Eugene Strandness

Research output: Contribution to journalArticle

431 Citations (Scopus)

Abstract

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. Methods and Results - Study inclusion criteria included age ≤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 ≤ 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.

Original languageEnglish (US)
Pages (from-to)678-686
Number of pages9
JournalCirculation
Volume98
Issue number7
StatePublished - Aug 18 1998
Externally publishedYes

Fingerprint

Intermittent Claudication
Placebos
Ankle
Walking
Therapeutics
Outcome Assessment (Health Care)
Physicians
Pressure
Ankle Brachial Index
Arterial Occlusive Diseases
Intention to Treat Analysis
Phosphodiesterase Inhibitors
Patient Safety
Vasodilator Agents
Exercise Test
Platelet Aggregation
cilostazol
Lower Extremity
Analysis of Variance
Smoking

Keywords

  • Cilostazol
  • Claudication
  • Drugs
  • Peripheral vascular disease

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Cilostazol has beneficial effects in treatment of intermittent claudication : Results from a multicenter, randomized, prospective, double- blind trial. / Dawson, David L; Cutler, Bruce S.; Meissner, Mark H.; Strandness, D. Eugene.

In: Circulation, Vol. 98, No. 7, 18.08.1998, p. 678-686.

Research output: Contribution to journalArticle

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abstract = "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. Methods and Results - Study inclusion criteria included age ≤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 ≤ 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.",
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