Strong PAH data for Tracleer plus sildenafil

The US unit of Swiss biotechnology firm Actelion has reported positive results from two trials demonstrating that Tracleer (bosentan) may be safe and effective as a combination therapy for the treatment of pulmonary arterial hypertension. Data from both studies suggest that Tracleer, when given in combination with sildenafil, the active ingredient of Pfizer's erectile dysfunction drug Viagra, is well-tolerated and improves hemodynamics in PAH patients. The findings were presented at CHEST 2007, the annual meeting of the American College of Chest Physicians, held in Chicago.

COMPASS-1 was the first clinical trial to provide detailed hemodynamic information on the combination of Tracleer and sildenafil, and showed that acute oral sildenafil plus long-term Tracleer therapy significantly reduced pulmonary vascular resistance. Data from the sildenafil cohort of the Phase III EARLY study showed that Tracleer improved hemodynamics and suggested a delay in disease progression in sildenafil-treated mildly symptomatic PAH patients. The EARLY trial was the first study of its kind to evaluate the benefit of this combination therapy.

"Despite the availability of effective PAH therapies, we are not meeting key treatment goals for long-term stabilization in the majority of patients," said Nazzareno Galie, lead author of the COMPASS-1 study. "Given the progressive and destructive nature of this disease, combining therapies with different modes of action has become an important focus for research, and these results support our belief that adding bosentan to sildenafil could potentially slow disease progression," he added.