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Published on: June 29, 2013
Cilostazol: improving walking distance in patients with intermittent claudication
Deborah J Collinson1, Richard Donnelly
1University of Nottinham Medical School, Derby City General Hospital, Uttoxeter Road, Derby, DE22 3DT, UK.
Insights
Cilostazol effectively improves walking distance for patients with intermittent claudication, a common peripheral arterial disease symptom. This medication offers a safe and tolerable option when surgery is not feasible.
Area of Science:
- Vascular Medicine
- Pharmacology
Background:
- Intermittent claudication, a symptom of peripheral arterial disease, significantly impacts quality of life by limiting walking ability.
- Patients with intermittent claudication face increased cardiovascular risks and have limited effective medical treatment options beyond exercise.
- Surgical revascularization is only suitable for a small percentage of patients.
Purpose of the Study:
- To evaluate the efficacy and safety of cilostazol as a symptomatic treatment for intermittent claudication.
- To assess cilostazol's impact on pain-free and maximum walking distances in patients with peripheral arterial disease.
Main Methods:
- A meta-analysis of eight major, large-scale, multicenter, placebo-controlled, double-blind clinical trials involving over 2000 patients.
- Assessment of pain-free and maximum walking distances as primary efficacy endpoints.
Main Results:
- Cilostazol demonstrated significant improvements in both pain-free and maximum walking distances compared to placebo.
- The medication exhibited a favorable overall safety and tolerability profile across the studies.
- Meta-analysis confirmed the efficacy of cilostazol in managing intermittent claudication symptoms.
Conclusions:
- Cilostazol is the first approved medication shown to effectively relieve symptoms of intermittent claudication in large clinical trials.
- Administered as 100 mg twice daily, cilostazol is licensed in the UK, USA, and Japan as an adjunct to exercise for managing moderate-to-severe intermittent claudication.
Abstract:
Intermittent claudication is a common, disabling symptom of peripheral arterial disease that limits walking distance and is associated with an increased cardiovascular risk of acute limb- or life-threatening complications. Very few patients with intermittent claudication (<7%) are suitable candidates for surgical revascularization, yet in contrast to the treatment of stable angina, few effective medical therapies (apart from exercise) are available for the symptomatic relief of intermittent claudication. The phosphodiesterase-3 inhibitor, cilostazol (Pletal, Otsuka Pharmaceuticals Ltd), is the first symptom-relieving treatment for intermittent claudication that has been evaluated successfully in large multicenter placebo-controlled, double-blind clinical trials (involving >2000 patients). A meta-analysis of the eight major efficacy studies with cilostazol has shown significant improvements in pain-free and maximum walking distance, and a good overall safety and tolerability profile. Thus, in the UK, USA and Japan, cilostazol administered at 100 mg twice daily is licensed for symptom relief in patients with stable, moderate-to-severe intermittent claudication, as an adjunct to nonpharmacological approaches such as exercise.
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