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Analysis of the cilostazol safety database
1Department of Internal Medicine, Baylor College of Medicine, Houston, Texas, USA. cpratt@bcm.tmc.edu
The American Journal of Cardiology
|July 4, 2001
Summary
Cilostazol effectively reduces intermittent claudication symptoms. Clinical trials show it has an acceptable safety profile, with no increased cardiovascular risk compared to placebo or pentoxifylline.
Area of Science:
- Pharmacology
- Clinical Trials
- Cardiovascular Medicine
Background:
- Cilostazol is a phosphodiesterase inhibitor approved for intermittent claudication.
- Safety data from clinical trials are crucial for understanding drug efficacy and risk.
Purpose of the Study:
- To summarize safety data from Phase 3 clinical trials of cilostazol.
- To evaluate the cardiovascular safety and overall risk-benefit ratio of cilostazol.
Main Methods:
- Analysis of 8 Phase 3 controlled clinical trials involving 2,702 patients.
- Comparison of cilostazol (1,374 patients) with placebo (973 patients) and pentoxifylline (355 patients).
- Assessment of adverse events, serious cardiovascular events, and mortality over 12-24 week trials.
Main Results:
- Headache and gastrointestinal complaints were more frequent with cilostazol than placebo.
- Discontinuation rates due to headache were higher with cilostazol (1.3-3.7%) versus placebo (0.3%).
- Rates of serious cardiovascular events, myocardial infarction, stroke, and mortality were similar across cilostazol, placebo, and pentoxifylline groups.
Conclusions:
- Cilostazol demonstrates an acceptable risk-benefit ratio for intermittent claudication.
- No increased trend in cardiovascular morbidity or mortality was observed with cilostazol use.
- Postmarketing surveillance supports a favorable safety profile for cilostazol.