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Actelion Announces Positive Study with Bosentan (Tracleer) in,CTEPH

en compared to placebo, on either one of the two primary endpoints, change in pulmonary vascular resistance (PVR) and/or exercise capacity measured by six-minute walk distance after 16 weeks of treatment. The statistical analysis plan stipulated that, if either endpoint was significant, the study was to be considered positive. Other endpoints included change from baseline to week 16 in other hemodynamic parameters, Borg dyspnoea, WHO functional class, time to clinical worsening, NT-proBNP as well as quality of life assessments.

About Tracleer® in Pulmonary Arterial Hypertension (PAH) Tracleer® (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide 4. In clinical trials leading to the marketing approval of the drug, approximately 11% of PAH patients receiving Tracleer® experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age that do not use a reliable method of contraception, must not take Tracleer® 4. Online information on pulmonary arterial hypertension (PAH): www.pah-info.com As part of an international PAH awareness campaign supported by Actelion Pharmaceuticals, www.pah-info.com has been created to provide healthcare professionals and patients with accurate and continuously updated information on PAH. The website contains information on symptoms, causes, diagnosis and current treatment options in separate sections for healthcare professionals and patients. The website is supported by high-quality resources such as a glossary, links to an extensiv
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TAG: Actelion Announces Positive Study with Bosentan Tracleer CTEPH
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