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Abstract
[Tracleer](R) (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH); in the United States in PAH Functional Class III and IV to improve exercise capacity and decrease the rate of clinical worsening and in Europe in PAH Functional Class III to improve exercise capacity and symptoms as well as PAH Functional Class II where some improvements have also been shown. In the EU, Tracleer(R) is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Tracleer(R) has been made commercially available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide since 2001. In these seven years of clinical experience, more than 68,500 patients have been treated with Tracleer(R) (9).
[Jacques Archambault] continued: "Our dual endothelin receptor antagonist Tracleer(R) is the only PAH medicine to have demonstrated a delay in disease progression in three independent placebo-controlled, randomized clinical studies. Actelion will now communicate these important clinical findings to the Canadian PAH community to encourage early diagnosis and intervention." The results from EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) - published in "The Lancet" in June, 2008 (2) - document the relentlessly progressive nature of PAH, even in its early stages, and highlight the need for earlier treatment and intervention in PAH management. The PAH progression was evident from the deterioration in all evaluated parameters in the placebo group, including the rate of clinical worsening events. The primary endpoints for the EARLY trial were changes in pulmonary vascular resistance (PVR) and exercise capacity as measured by a 6-minute walk distance (6MWD). PAH progression was assessed by evaluating two secondary endpoints which were time to clinical worsening and change in WHO Functional Class. The key results of the EARLY study were: