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Tracleer(R) Shows Clinical Benefit as Combination Therapy with Sildenafil for Pulmonary Arterial Hypertension
Date:10/23/2007

- Studies Show Improvement in Hemodynamics and Delay Disease Progression -

CHICAGO, Oct. 23 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc. today announced positive results from two trials demonstrating that Tracleer(R) (bosentan) may be safe and effective as a combination therapy for the treatment of pulmonary arterial hypertension (PAH). Data from both studies suggest that Tracleer, when given in combination with sildenafil, is well-tolerated and improves hemodynamics in PAH patients. The data were presented at CHEST 2007, the annual meeting of the American College of Chest Physicians, taking place in Chicago.

COMPASS-1 (Effects of Combination Of bosentan and sildenafil versus sildenafil Monotherapy on morbidity and mortality in symptomatic PAtientS with pulmonary arterial hypertenSion) was the first clinical trial to provide detailed hemodynamic information on the combination of Tracleer and sildenafil, and showed that the combination of acute oral sildenafil together with long-term Tracleer therapy significantly reduced pulmonary vascular resistance (PVR).

Data from the sildenafil cohort of the Phase 3 EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) 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 Tracleer and sildenafil 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 from the University of Bologna, Italy, also the 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 s
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SOURCE Actelion Pharmaceuticals US, Inc.
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