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Cilostazol (Cilostazol) - Summary

 



CONTRAINDICATION

Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III to IV congestive heart failure. Cilostazol is contraindicated in patients with congestive heart failure of any severity.

 

CILOSTAZOL SUMMARY

CILOSTAZOL TABLETS
50 mg and 100 mg

Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (morespecific for phosphodiesterase III).

Cilostazol is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.


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NEWS HIGHLIGHTS

Published Studies Related to Cilostazol

Efficacy of cilostazol in reducing restenosis in patients undergoing contemporary stent based PCI: a meta-analysis of randomised controlled trials. [2009.08]
Aims: Cilostazol has been associated with reduction in restenosis in patients undergoing coronary and peripheral arterial angioplasty. Our objective was to evaluate the impact of cilostazol on restenosis in patients undergoing contemporary PCI with bare metal (BMS) or drug eluting stents (DES) and treated with aspirin and thienopyridine.Methods and results: Ten randomised trials (n=2,809 patients) comparing triple antiplatelet therapy (aspirin, thienopyridine and cilostazol) with standard dual antiplatelet therapy were included...

Combined aspirin and cilostazol treatment is associated with reduced platelet aggregation and prevention of exercise-induced platelet activation. [2009.05]
BACKGROUND: Cilostazol has proven efficacy in increasing walking distance in claudicants, but it has not been demonstrated to be more effective than placebo in secondary cardiovascular prevention. The direct effect of exercise on platelet function remains less well defined. We have investigated the effect of combination treatment with aspirin and cilostazol on platelet activity in claudicants subjected to repeated treadmill exercise... CONCLUSIONS: Combination treatment with aspirin and cilostazol results in suppression of platelet activation and reduces the effect of exercise on platelets. The benefit seen may be a result of cilostazol enhancing the inhibitory effect of aspirin on the cyclo-oxygenase pathway.

Effect of cilostazol treatment on adiponectin and soluble CD40 ligand levels in diabetic patients with peripheral arterial occlusion disease. [2009.05]
CONCLUSIONS: Cilostazol can decrease hs-CPR and sCD40L levels and increase that of adiponectin, and then delay the progression of atherogenesis and chronic inflammation in type 2 diabetics, especially those with PAOD.

The vascular and biochemical effects of cilostazol in patients with peripheral arterial disease. [2009.05]
OBJECTIVES: Cilostazol improves walking distance and quality of life in patients with peripheral arterial disease (PAD). This study assessed the vascular and biochemical effects of cilostazol therapy in PAD patients... CONCLUSION: Cilostazol is a well-tolerated, safe, and efficacious treatment for PAD patients. It not only improves patients' symptomatology and quality of life but also appears to have beneficial effects on arterial compliance, possibly through its lipid-lowering property.

Cilostazol in addition to aspirin and clopidogrel improves long-term outcomes after percutaneous coronary intervention in patients with acute coronary syndromes: a randomized, controlled study. [2009.04]
BACKGROUND: Cilostazol has been widely used to prevent peripheral vascular events, and its antiplatelet mechanisms may different from aspirin and clopidogrel. We hypothesized that cilostazol in addition to aspirin and clopidogrel effectively reduces systemic ischemic events after percutaneous coronary intervention (PCI) in high-risk patients... CONCLUSIONS: For patients with acute coronary syndromes, triple-antiplatelet therapy consisting of cilostazol, aspirin, and clopidogrel reduced long-term cardiac and cerebral events after PCI, especially for patients with high-risk profiles.

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Clinical Trials Related to Cilostazol

Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.

Post-Marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2) [Active, not recruiting]
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Cilostazol in Acute Ischemic Stroke Treatment (CAIST) [Active, not recruiting]
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke [Completed]
The study design is subject to relevant SFDA regulations about clinical trials. This indication was approved in Japan in 2003.

From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral infarction(see the inclusion criteria) were enrolled in to the study and received one of the two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is 1: 1. For each patient, the chance of entering either of these two groups is the same. The treatment will continue till the end of 2005. During the treatment period, patients will be observed concerning some certain events, mainly reoccurrence of stroke. If the patient experiences reoccurrence of stroke, or other event that the doctors think it is not appropriate to continue the study medication, this patient would stop the treatment. Patients were also required to take MRI head scan before entering the study and on completion of the treatment.

Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo [Active, not recruiting]
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed

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Page last updated: 2009-10-20

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