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

low disease progression."

"The results of the COMPASS-1 and EARLY studies demonstrate that Tracleer, when used alone or in combination with other therapies, appears to be well-tolerated and an effective treatment option for patients with PAH," said Craig Hopkinson, vice president of U.S. medical at Actelion. "Actelion is committed to conducting studies with Tracleer in combination with other approved therapies in order to evaluate the drug's effect in a combination therapy setting on delaying disease progression and improving patient care."

COMPASS-1 Study Details and Results

The COMPASS-1 trial assessed the acute hemodynamic effects of sildenafil in combination therapy with Tracleer. The open-label, uncontrolled, prospective, multicenter study evaluated 45 patients receiving Tracleer and measured PVR with the addition of inhaled nitric oxide (iNO) and a single 25mg dose of sildenafil.

The % change in PVR induced by iNO and sildenafil was similar. Sildenafil lowered mean PVR by 15.1% from 828+/-724 to 721+/-651 dyne.s.cm-5 60 minutes after intake (p<0.0001). iNO was shown to reduce mean PVR by 14.9% from 807+/-635 to 745+/-740 dyne.s.cm-5 after inhalation (p<0.0001).

EARLY Study Details and Results

The EARLY trial evaluated the safety and efficacy of Tracleer in mildly symptomatic (WHO Functional Class II) PAH patients. This randomized, double-blind, placebo-controlled trial (n=185) assessed the efficacy of Tracleer as a monotherapy and as a combination therapy in patients receiving background sildenafil treatment (n=29).

Mean baseline PVR was higher in patients receiving sildenafil than in patients not taking sildenafil; and six-minute walk distances were similar at baseline. At six months, patients treated with Tracleer (in sildenafil and non-sildenafil subgroups) both saw a reduction in PVR (-20%, P=0.0478 sildenafil; -23%, P<0.0001 no sildenafil).

Data from the trial also suggest that Tracleer is effective in early
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SOURCE Actelion Pharmaceuticals US, Inc.
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