Positive study with Actelion's bosentan (Tracleer®) in CTEPH
Actelion Ltd announced the initial results from the double-blind, placebo-controlled, multicenter study BENEFiT (Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension). The study met its primary objective, as treatment with bosentan (Tracleer®) was associated with a significant reduction in pulmonary vascular resistance PVR (p<0.0001).
In this first-ever double-blind study in a patient population suffering from this form of pulmonary hypertension, the six-minute walk test remained stable over the four months of blinded evaluation in both treatment groups. Patients on bosentan showed a significant improvement in breathlessness (Borg dyspnoea score) with exercise and there was a trend in favor of bosentan towards prevention of worsening WHO functional class.
Initial results also indicate that treatment with bosentan was associated with a significant decrease in NT-proBNP, an important biomarker of disease severity. In this study, Tracleer ®'s safety and tolerability profile was consistent with that observed in previous placebo-controlled clinical trials in pulmonary arterial hypertension (PAH).
CTEPH is caused by obstruction of the pulmonary arteries by organized persistent thrombi leading to increased pulmonary vascular resistance, progressive pulmonary hypertension and ultimately right-heart failure.
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