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Transition from intravenous epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial.

Author(s): Rubenfire M, McLaughlin VV, Allen RP, Elliott G, Park MH, Wade M, Schilz R

Affiliation(s): University of Michigan Health System, Ann Arbor, MI.

Publication date & source: 2007-03-30, Chest., [Epub ahead of print]

Background We determined the relative efficacy of subcutaneous (SC) treprostinil in stable (World Health Organization) WHO class II and III patients transitioned from intravenous epoprostenol. Methods An eight-week multicenter randomized study in which patients were transitioned from intravenous epoprostenol to SC treprostinil or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration. Patients who deteriorated were returned promptly to epoprostenol. Placebo or SC treprostinil dose was titrated in response to symptoms. Time to adjudicated clinical deterioration was compared between treatment groups, and exercise capacity, symptoms of disease and safety were assessed throughout the study. Results Twenty-two patients were enrolled and completed the study. Seven of 8 patients (93%) withdrawn to placebo deteriorated, while only 1 of 14 patients (14%) withdrawn to SC treprostinil had a clinical deterioration event (p=0.00023 based on a treatment comparison of time to deterioration). Analyses of exercise capacity and symptoms strongly supported the efficacy of SC treprostinil in epoprostenol treated patients. Adverse events consisted of painful infusion site reactions and anticipated prostacyclin side effects. Conclusions Subcutaneous treprostinil is effective in pulmonary arterial hypertension and prevents clinical deterioration and maintains functional status in patients transitioned from epoprostenol. Trial number conducted prior to registration requirement.

Page last updated: 2007-05-02

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