A New Pharmacological Treatment for Intermittent Claudication:

Hg, Beebe; Dl, Dawson; Bs, Cutler; Ja, Herd; De, Suvranu; Eb, Bortey; Wp, Forbes

doi:10.1001/archinte.159.17.2041

Cited by 283 publications

(219 citation statements)

References 24 publications

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“…Cilostazol had been studied in 10 trials of patients with peripheral arterial disease, and has been shown to improve maximum walking distance in most of them. At 37 sites in the United States, Beebe et al (15) randomly assigned 516 men and women 40 years and older with moderately severe chronic, stable, symptomatic intermittent claudication to cilostazol 100 mg twice daily, cilostazol 50 mg twice daily or placebo for 24 weeks. Outcome measures included pain-free and maximal walking distance on a treadmill, quality of life, global assessments by patients and physicians, and cardiovascular morbidity and allcause mortality.…”

Section: Treatment Of Peripheral Arterial Diseasementioning

confidence: 99%

The vascular effects of cilostazol

Weintraub

2006

Canadian Journal of Cardiology

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Section: Treatment Of Peripheral Arterial Diseasementioning

confidence: 99%

The vascular effects of cilostazol

Weintraub

2006

Canadian Journal of Cardiology

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“…11 Cilostazol, a phosphodiesterase type III inhibitor, has recently been evaluated in trials that have documented an increased walking ability and improved quality of life. 12,13 This class of drugs is, however, contraindicated in patients with heart failure. Serotonin (5-HT) is a major non-peptidergic substance released from activated platelets, which mediates vasoconstriction and is involved in vascular inflammation leading to atherosclerosis.…”

Section: Discussionmentioning

confidence: 99%

Sarpogrelate, a 5-HT2A receptor antagonist in intermittent claudication. A Phase II European study

Norgren

Jawień

Mátyás³

et al. 2006

Vasc Med

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This was a multinational, multicentre, double-blind Phase II study in Europe to evaluate the efficacy and safety of two dose regimens (200 mg bid and 200 mg tid) of sarpogrelate (MCI-9042, 5-HT2A receptor antagonist) compared to placebo in patients with stable, moderately severe intermittent claudication. Following a single-blind placebo run-in period of 6 weeks, 364 (309 male and 55 female) patients (59.2 ± 8.4 years, mean SD) were randomized to receive sarpogrelate 200 mg bid, 200 mg tid or placebo for 24 weeks with a follow-up of 8 weeks. The primary objective was the increase of absolute claudication distance (ACD) at the end of treatment (week 24) compared to placebo. Analysis of covariance (ANCOVA) was performed on the log-transformed percentage of baseline ACD: loge (ACD/baseline). A responder analysis (defined as a 50% improvement in ACD) was also performed. There was a marked training/placebo effect on the ACD which persisted up to 16 weeks. At 24 weeks the primary objective did not reach statistical significance (200 mg bid vs placebo, p = 0.225; 200 mg tid vs placebo, p = 0.580). In the responder analysis, 200 mg bid showed a statistically significant difference vs placebo ( p = 0.035). In the exploratory analysis with completers (patients completing all treadmill tests), there was a statistical difference in ACD/baseline change for 200 mg bid ( p = 0.035) and in the responder analysis for 200 mg tid ( p = 0.044) at 24 weeks compared to placebo. Both treatments showed a carry-over effect for ACD during the 8-week follow-up (weeks 28-32). The treatment was well tolerated and no clinically significant safety concerns were reported. In conclusion, the study results confirm that sarpogrelate is well tolerated and although the primary endpoint failed to reach statistical significance, the responder analysis showed an increased absolute walking distance, which makes a further trial warranted, including a larger population, and possibly also a longer treatment period.

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“…In two studies it was necessary to interrupt the use of cilostazol due to headaches in 1.7% of the patients in relation to 1.3% in those treated with placebo, while suspension for other causes was similar between the groups 16,17 . In the case of chronic liver disease, Child-Pugh classes B and C, it should be used with caution 18 .…”

Section: Pharmacological Properties Of Cilostazolmentioning

confidence: 99%