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| __NOTOC__
| | #REDIRECT [[Cilostazol#Clinical Studies]] |
| {{Cilostazol}}
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| {{CMG}}; {{AE}} {{AK}}
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| ==CLINICAL STUDIES==
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| The ability of PLETAL to improve walking distance in patients with stable [[intermittent claudication]] was studied in eight large, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks' duration using dosages of 50 mg b.i.d. (n=303), 100 mg b.i.d. (n=998), and placebo (n=973). Efficacy was determined primarily by the change in maximal walking distance from baseline (compared to change on placebo) on one of several standardized exercise treadmill tests.
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| Compared to patients treated with placebo, patients treated with PLETAL 50 or 100 mg b.i.d. experienced statistically significant improvements in walking distances both for the distance before the onset of [[claudication ]]pain and the distance before exercise-limiting symptoms supervened (maximal walking distance). The effect of PLETAL on walking distance was seen as early as the first on-therapy observation point of two or four weeks.
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| The following figure depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies.
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| [[image:Cilo2.png]]
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| Across the eight clinical trials, the range of improvement in maximal walking distance in patients treated with PLETAL 100 mg b.i.d., expressed as the percent mean change from baseline, was 28% to 100%.
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| The corresponding changes in the placebo group were –10% to 41%.
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| The Walking Impairment Questionnaire, which was administered in six of the eight clinical trials, assesses the impact of a therapeutic intervention on walking ability. In a pooled analysis of the six trials, patients treated with either PLETAL 100 mg b.i.d. or 50 mg b.i.d. reported improvements in their walking speed and walking distance as compared to placebo. Improvements in walking performance were seen in the various subpopulations evaluated, including those defined by gender, smoking status, diabetes mellitus, duration of peripheral artery disease, age, and concomitant use of [[beta blockers]] or[[ calcium channel blockers]]. PLETAL has not been studied in patients with rapidly progressing claudication or in patients with leg pain at rest, ischemic leg ulcers, or [[gangrene]]. Its long-term effects on limb preservation and hospitalization have not been evaluated.
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| A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with respect to mortality and safety, in 1,439 patients with [[intermittent claudication]] and no [[heart failure]]. The trial stopped early due to enrollment difficulties and a lower than expected overall death rate. With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95% CI of 2.8 to 8.4%) on cilostazol and 6.8% (95% CI of 1.9 to 11.5%) on placebo. These data appear to be sufficient to exclude a 75% increase in the risk of mortality on cilostazol, which is the a priori study hypothesis.
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| <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PLETAL (CILOSTAZOL) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]]
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