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

Summary

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.

Timeline

Start

2009-04

Primary completion

2010-11

Completion

2010-11

Outcome

Met primary endpoint

paper flow-mediated arterial dilation of 2.43 ± 0.3% (95% CI 1.75 to 3.12; p = 0.001) PMID 26651453 ↗

paper a decrease in C-reactive protein levels of -2.0 ± 0.5 mg/L (95% CI -2.8 to -1.1; p = 0.02) were observed in the bosentan-treated group compared to the control group. PMID 26651453 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	125 mg	—
Background	AAS	Unknown	100 mg	—
Background	Clopidogrel	Small molecule	75 mg	—

Indications