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Triumph-1 Trial of Viveta in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:11/1/2007

ined by the trial protocol as 10-60 minutes after inhalation of Viveta, relative to baseline. Preliminary analysis of the TRIUMPH-1 results demonstrates an improvement in median 6MW distance by approximately 20 meters (p<0.0006, Hodges-Lehmann estimate and non-parametric analysis of covariance in accordance with the trial's pre-specified statistical analysis plan), in patients receiving Viveta as compared to patients receiving placebo.

The trough exposure, defined by the trial protocol as a minimum of four hours after inhalation of Viveta, for treatment change in 6MW distance at week 12 relative to baseline was also significantly improved, with an increase in median 6MW distance of approximately 14 meters (p<0.01). Additionally, the 6MW distance at week 6 relative to baseline was significantly improved, with an increase in median 6MW distance of approximately 18 meters (p<0.0005).

Preliminary analysis of other secondary efficacy measures, including change in Borg Dyspnea Scale rating (shortness of breath test), NYHA functional class, time to clinical worsening (as defined by death, transplant, atrial septostomy, hospitalization due to PAH, or initiation of another approved PAH therapy), and the 6MW distance at treatment day 1, did not differ significantly between the Viveta and placebo groups (p>0.05). Analysis of two remaining secondary endpoints, quality of life and signs and symptoms of disease (composite measure) is ongoing.

Viveta was generally well-tolerated in the trial and adverse events appeared to be similar to those previously reported for treprostinil. The most common adverse events seen in the trial were transient cough, headache, nausea, dizziness and flushing. Detailed analysis of the reported adverse events is ongoing. All patients in the trial had the option to continue receiving Viveta in an open-label continuation study after completion of the 12-week study period. Of the 212 patients who completed the 12-week study period, appro
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SOURCE United Therapeutics Corporation
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