Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

CLAU Test Results (CLinical Assessment And Endothelin fUnction Assessment After Endothelin Receptor Antagonist) : Randomized Controlled Clinical Trial of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with Intermittent Claudication (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.

Inclusion Criteria:

• Arterial hypertension and hypercholesterolemia
• ABI <0,9
• Positive claudiometry with a claudication distance between 50 and 500

Exclusion Criteria:

• surgical patient
• Previous revascularization procedure in the Member studied
• Smoker
• Uncontrolled hypertension
• Cardiac Stress Test unfinished
• Prior DVT
• Concomitant severe disease
• Obesity