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| |  ACR: Treprostinil (Remodulin) Improves Quality of Life in Some Patients with Pulmonary Arterial Hypertension By Lynn Haley Special to DG News SAN FRANCISCO, CA -- November 19, 2001 -- Patients with pulmonary arterial hypertension (PAH) related to connective tissue disease (CTD) show a significant improvement in quality of life when treated with Treprostinil (Remodulin). The study researchers from the Treprostinil Study Group in Torrance, California, Cleveland, Ohio, and the Research Triangle Park in North Carolina presented their findings at the 2001 Annual Scientific Meeting of the American College of Rheumatology, held here November 10th-15th. Investigators from all sites conducted randomised, placebo-controlled, prospective studies in 469 patients with PAH. This study reports on 90 patients with PAH related to CTD, including 25 with lupus, 25 with diffuse scleroderma, 20 with limited scleroderma, and 20 with mixed CTD/overlap syndrome. Forty-nine patients received placebo and 41 received treprostinil (TRE). Pulmonary arterial hypertension is the leading cause of death in limited scleroderma and a significant cause of morbidity in patients with other connective tissue disorders. To date, epoprostenol (EPO) is the only approved therapy for PAH patients, but delivery of the drug requires infusion via a central venous catheter and has a half-life of one to two minutes. Treprostinil, an EPO analogue, has a three-hour half-life, is stable at room temperature and can be administered subcutaneously. At baseline, mean baseline six-minute walk was 289 metres. At week 12, the average dose of TRE was 7.8 ng/kg/min. Results showed that three months following treatment, CTD patients receiving TRE were able to walk significantly further with less dyspnea (+21)(p=0.055), and heart-and-lung capacity also improved (Borg Dyspnea Score -0.8, p=0.17; Dyspnea-Fatigue Rating +0.82, p=0.014). Pulmonary hypertension is an important cause in the decline of day-to-day living and quality of life in patients with CTD. Treprostinil has been shown to be safe and effective in treating these patients. "The improvement in important areas of functionality, particularly increasing the ability to exercise with reduction of symptoms, combined with a safer, less invasive drug delivery system with treprostinil, is an important addition to the treatment options for these severely ill patients," said Dr. Ronald Oudiz, lead author and Director for the Liu Centre for Pulmonary Hypertension, Research and Education Institute at Harbor-UCLA Medical Centre. The investigators concluded that continuous subcutaneous infusion of TRE in patients with PAH related to CTD improved exercise capacity, symptoms of PAH and hemodynamics. Improvement in exercise capacity appeared to be related to the dosage of TRE. The authors recommend further study to determine the effect of TRE on mortality in this patient population. Two of the researchers, Drs. Oudiz and Schilz, received grants to conduct their research, while authors Carl Arneson and Dr. Roger Jeffs are employees of United Therapeutics and have stock options as part of their compensation.
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