Regular paperMeta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication☆
Section snippets
Trial selection:
We reviewed 8 phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design trials (Table 1) conducted to assess the safety and efficacy of cilostazol in patients with moderate to severe intermittent claudication. Exercise treadmill testing was performed in all trials to assess patient response to therapy. Treatment periods ranged from 12 to 24 weeks. Multicenter studies were performed at 98 sites in the United States (7 trials) and the United Kingdom (1 trial).
Study patients:
Patients
Data set analyzed:
Of the 2,702 randomized patients, 172 failed to complete the first treadmill test after randomization and 78 were excluded for other data deficiencies. Because the 150-mg twice-daily cilostazol dosage was used in only 1 trial and does not represent pooled data, these patients were also excluded from the present analysis of 2,399 patients. In all, 511 patients withdrew from the trials because of medical problems (Table 2). Headache, palpitations, and diarrhea were the most frequently reported
Discussion
The present combined results for 8 trials comparing cilostazol with placebo or pentoxifylline in patients with claudication document that cilostazol, 100 mg twice daily, increased MWD by 50% and pain-free walking distance by 67% from baseline. Cilostazol, 50 mg twice daily, increased MWD by 44% and pain-free walking distance by 60% from baseline. These changes were significantly greater than the increases in MWD observed with pentoxifylline (38%) and placebo (21%) treatment. Cilostazol was also
References (17)
- et al.
A comparison of cilostazol and pentoxifylline for treating intermittent claudication
Am J Med
(2000) - et al.
Trans-Atlantic conference on clinical trial guidelines in PAOD (peripheral arterial occlusive disease) clinical trial methodology
Eur J Vasc Endovasc Surg
(1999) - et al.
The effect of withdrawal of drugs treating intermittent claudication
Am J Surg
(1999) - et al.
Cilostazol
Cardiovasc Drug Rev
(1993) - et al.
Cilostazol has beneficial effects in treatment of intermittent claudicationresults from a multicenter, randomized, prospective, double-blind trial
Circulation
(1998) - et al.
A new pharmacological treatment for intermittent claudicationresults of a randomized, multicenter trial
Arch Intern Med
(1999) - et al.
Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease
J Vasc Surg
(1998) - et al.
Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication
Arterioscler Thromb Vasc Biol
(1998)
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This study was supported by grants from Otsuka America Pharmaceutical, Inc., Rockville, Maryland.