The so-called Breath-5 study evaluated the use of Tracleer (bosentan) in patients with Eisenmenger’s syndrome, a progressive heart condition that occurs in people who have a congenital heart defect or hole in the heart, resulting in the development of a severe form of pulmonary arterial hypertension (PAH). This syndrome cannot be treated by any conventional means, including surgery.
The multi-centre study is the first ever trial to show benefit in this very sick group of patients. The standard regime of Tracleer was used treating a total of 54 patients over 16 weeks.
The results show that patients with bosentan treatment demonstrate a decrease in pulmonary vascular resistance (PVR) and an improvement in exercise capacity without a worsening in oxygen saturation. Overall the bosentan safety and tolerability profile was comparable to that observed in previous placebo-controlled clinical trials in PAH with Tracleer.
Dr Michael Landzberg from Brigham and Womens Hospital, Boston and principal investigator for the study commented: “Eisenmenger’s syndrome is a field of high unmet medical need. It is remarkable that in this disease, which was believed to be characterized by irreversible vascular lesions, finally a drug has shown an improvement in exercise capacity. At the same time Tracleer was well tolerated.”