From the Division of Vascular Surgery (D.L.D., M.H.M., D.E.S.),
Department of Surgery, University of Washington, Seattle and The University of
Massachusetts Medical Center (B.S.C.), Worcester, Mass. Dr Dawson is currently
at Wilford Hall Medical Center, Lackland AFB, Tex.
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
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.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Cilostazol Has Beneficial Effects in Treatment of Intermittent Claudication
Results From a Multicenter, Randomized, Prospective, Double-blind Trial
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.
Key Words: claudication • peripheral vascular disease • cilostazol • drugs
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