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

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.

Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy

To determine the efficacy of bosentan on the improvement in the absolute claudication distance in the exercise in patients with Intermittent Claudication due Peripheral Arterial Disease. ACD and percentage of change, both for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

To determine the efficacy of bosentan on the improvement in the overall endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease FMAD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease. Analytical values : plasma electrolyte values, hepatic function, renal function, coagulation profiles, peripheral blood cell count

Efficacy of bosentan on the improvement in the hemodynamic states in patients with Intermittent Claudication due Peripheral Arterial Disease. ABI for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values

Efficacy of bosentan on the improvement of functional status (symptoms of claudication) in patients with Intermittent Claudication due Peripheral Arterial Disease SCD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease

To determine the efficacy of bosentan on the improvement in inflammatory status in patients with Intermittent Claudication due Peripheral Arterial Disease. CRP for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

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

De Haro J, Bleda S, Varela C, Esparza L, Acin F; Bosentan Population-Based Randomized Trial for Clinical and Endothelial Function Assessment on Endothelin Antagonist Therapy in Patients With Intermittent Claudication CLAU Investigators. Effect of Bosentan on Claudication Distance and Endothelium-Dependent Vasodilation in Hispanic Patients With Peripheral Arterial Disease. Am J Cardiol. 2016 Jan 15;117(2):295-301. doi: 10.1016/j.amjcard.2015.10.032. Epub 2015 Nov 6.