Actelion's Tracleer shows benefit in FC II PAH

Swiss drugmaker Actelion says that a pivotal pulmonary arterial hypertension study published in The Lancet concludes that Tracleer (bosentan) demonstrates benefits in mildly symptomatic WHO Functional Class II patients.

According to the firm, the agent prevented clinical deterioration by significantly delaying time-to-clinical worsening and reduced the number of patients deteriorating to WHO FC III/IV. A significant reduction in pulmonary vascular resistance and a positive trend in increasing the six-minute walk distance test were also observed. The randomized, placebo-controlled EARLY trial is the first and only one conducted exclusively in a dedicated FC II PAH population.

Nazzareno Galie of the University of Bologna, Italy, and lead investigator, said: "the EARLY trial demonstrates that, without treatment, even mildly symptomatic patients experience PAH progression within a short period of time. In contrast, treatment with bosentan significantly delayed PAH progression while improving hemodynamic parameters."