The study which gathered data between May 2002 and November 2004 confirms the safety profile of bosentan, (marketed as Tracleer), as seen in previous phase III clinical trials. The findings represent the completion of the largest non-interventional study to date of patients treated with bosentan for pulmonary arterial hypertension (PAH) in daily medical practice.
The data also demonstrated that the addition of sildenafil and atorvastatin to bosentan in PAH patients was well tolerated and showed a trend towards a beneficial effect on exercise tolerance.
According to Actelion, untreated PAH patients die an average of 2.8 years after diagnosis. Bosentan is the first and only approved oral treatment for PAH (class III and IV) to improve exercise capacity and decrease the time to clinical worsening. Bosentan is a dual endothelin receptor antagonist (ERA). It works by comprehensively blocking the binding of endothelin (ET) to both of its receptors ETA and ETB, thereby preventing the deleterious effects of ET.
Dr Marius Hoeper, University of Hanover Medical School, Germany, commented: “It is important to further confirm if sildenafil can be safely used in patients receiving treatment with bosentan as it would appear to be a useful additional therapy for some patients being treated for PAH.”