Key result
Cilostazol boosts maximal walking distance by ~21% versus placebo at 24 weeks.
Why the study?
The efficacy and safety of cilostazol at different doses compared with placebo in patients with moderately severe intermittent claudication were evaluated.
Does cilostazol improve walking distance and symptoms in patients with intermittent claudication secondary to peripheral arterial disease?
RCT (n=394)
Double-blind
parallel
Yes
Does cilostazol improve walking distance and symptoms in patients with intermittent claudication secondary to peripheral arterial disease?
Effect estimate: 21% net improvement
p-value: p=0.0003
Cilostazol 100 mg twice daily significantly improves objective walking distance and functional status in patients with intermittent claudication.
Supports cilostazol 100 mg BID for moderate IC symptom relief; confirms walking distance gains in this dedicated RCT.
A multicenter, double-blind, randomized, placebo-controlled, parallel study was conducted to compare the efficacy and safety of cilostazol 100 mg and 50 mg, both administered twice daily, with that of placebo in patients with moderately severe intermittent claudication (IC) secondary to peripheral arterial disease.A total of 394 subjects 40 years of age or older with chronic, stable, symptomatic IC received cilostazol 100 mg twice daily, 50 mg twice daily, or placebo for 24 weeks. Subjects receiving cilostazol 100 mg twice daily experienced a 21% net improvement in maximal walking distance (MWD)compared with placebo subjects (p = 0.0003) and a 22% net improvement in distance walked to the onset of symptoms (PFWD) (p = 0.0015). Subjects who received cilostazol 50 mg twice daily also benefited from therapy, but not to a statistically significant degree (7% and 11% improvement in MWD and PFWD, respectively). Quality-of-life and functional status assessments corroborated these objective results. Cilostazol, in particular 100 mg twice daily, significantly improves symptoms in patients with IC.
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Strandness et al. (2002) conducted an RCT in Intermittent claudication secondary to peripheral arterial disease (n=394). Cilostazol vs. Placebo was evaluated on Maximal walking distance (MWD) (21% net improvement, p=0.0003). Cilostazol 100 mg twice daily significantly improved maximal walking distance by 21% (p=0.0003) and distance to symptom onset by 22% (p=0.0015) compared to placebo.
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