Pletal (Cilostazol) - Summary

PLETAL SUMMARY

PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III).

PLETAL 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 Pletal (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 Pletal (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.

Evaluation of Cilostazol in Combination With L-Carnitine [Recruiting]
The purpose of this study is to see how safe and effective L carnitine taken with cilostazol is compared to placebo taken with cilostazol for people with intermittent claudication. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.

Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon [Completed]
Juvenile primary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud’s Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud’s Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud’s episodes in juvenile patients.

Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon [Completed]
Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud’s are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynaud’s episodes in juvenile patients.

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).

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