Tracleer Excellence Post Marketing Surveillance Programme (TRAX PMSTM) confirms long-term safety profile

06-Sep-2005

Actelion Ltd announced that two abstracts presented at the European Society of cardiology (ESC) conference confirm the long-term safety profile of Tracleer® (bosentan) in treating pulmonary arterial hypertension (PAH). Both abstracts comprise data from TRAX PMSTM, which was set up in the EU in May 2002 to collect potential safety signals associated with the use of bosentan. Between May 2002 and November 2004 almost 5,000 patients were enrolled in the TRAX PMSTM. Data presented from 579 European patients with PAH associated with CHD (congenital heart disease), and 470 patients with CTEPH (a serious condition characterised by long-standing obstruction of the large pulmonary arteries, leading to impairment of normal blood flow through lungs) showed that potential safety signals were recorded in 19.7% and 34.5% of patients, respectively. This compares with 36.7% seen in patients with idiopathic PAH (iPAH).

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