SATELLITE BEACH, Fla., Oct. 10 /PRNewswire-FirstCall/ -- Lung Rx, Inc., a wholly owned subsidiary of United Therapeutics Corporation , announced the publication of "Safety and Efficacy of Inhaled Treprostinil as Add-On Therapy to Bosentan in Pulmonary Arterial Hypertension" in the current issue of The Journal of The American College of Cardiology (October 3, 2006, volume 48, number 7, pp. 1433-1437). Treprostinil Sodium for Inhalation is an investigational compound being developed by Lung Rx for the treatment of severe pulmonary arterial hypertension.
This publication details results from an investigator-initiated open-label clinical trial evaluating the effects of inhaled treprostinil as add-on therapy to oral bosentan in the management of pulmonary arterial hypertension. Researchers at the University of California, San Diego Medical Center studied 12 patients who remained symptomatic at New York Heart Association (NYHA) functional class level III or IV despite being treated with oral bosentan for at least 12 weeks. Treprostinil was delivered via a hand-held ultrasonic, single-breath inhalation device. Two dosing regimens were evaluated: six inhalations four times daily, and nine inhalations four times daily. Each treatment was completed in approximately one minute.
Inhaled treprostinil treatment was associated with a peak (post- inhalation) 67-meter improvement in the six-minute walk test at 12 weeks based on results in 11 evaluable patients (p=0.01). An improvement of 49-meters was observed at the trough period just before inhalation (p<0.01). Significant improvement was also noted in cardiopulmonary hemodynamics and NYHA functional class.
"The data presented in this article suggest inhaled treprostinil may prove to be a safe and effective treatment in the management of pulmonary arterial hypertension, particularly when used as add-on therapy to bosentan," said senior author, Lewis J. Rubin, MD, Professor of Medicine and Director, Pulmonary Hypertension Program at the University of California, San Diego Medical Center, La Jolla, CA.
"This is the first publication in a peer reviewed journal of a cohort of patients sub-optimized on bosentan receiving inhaled treprostinil chronically," said Robert Roscigno, Ph.D., President and Chief Operating Officer of Lung Rx. "We are pleased to see the very exciting findings of the UCSD open-label study, and look forward to completing the confirmatory TRIUMPH (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) I study." TRIUMPH is a 12-week, double-blind, randomized, placebo-controlled study of inhaled treprostinil in NYHA Class III and IV patients with severe pulmonary arterial hypertension that is being conducted at approximately 36 centers in the United States and Europe.
The authors reported that patients tolerated inhaled treprostinil therapy with no serious adverse events occurring in the trial. There were no reports of obvious "rebound" effects between treatments, specifically, no syncope or clinical deteriorations were reported. Transient cough, headache, and sore throat were reported, but the occurrences were not sufficient to limit compliance. These study results were first announced at the 2005 American Heart Association Scientific Sessions in Dallas, Texas.
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