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In eight randomizedplacebo-controlleddouble-blind clinical trialsaspirin was coadministered with cilostazol to 201 patientsThe most frequent doses and mean durations of aspirin therapy were 75-81 mg daily for 137 days107 patientsand 325 mg daily for 54 days85 patientsThere was no apparent increase in frequency of hemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo and equivalent doses of aspirin.
A randomizeddouble-blindplacebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazolwith respect to mortality and safetyin 1,439 patients with intermittent claudication and no heart failureThe trial stopped early due to enrollment difficulties and a lower than expected overall death rateWith respect to mortalitythe observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.695CI of 2.8 to 8.4on cilostazol and 6.895CI of 1.9 to 11.5on placeboThese data appear to be sufficient to exclude a 75increase in the risk of mortality on cilostazolwhich was the a priori study hypothesis.
Based on AUCthe overall pharmacological activity of cilostazol increases 34when co-administered with erythromycinBased on these datathe recommended dose of cilostazol is 50 mg bid in the presence of erythromycin and similar agentse.gclarithromycin
Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Ask your doctor for a list of these medicines if you are not sureYou can ask your pharmacist for a list of medicines that interact with PletalKnow the medicines you takeKeep a list of them to show to your doctor and pharmacist when you get a new medicine.
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