Chest ACCP Education Calendar
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
QUICK SEARCH:   [advanced]


     

Guest Access | Sign In via User Name/Password
First published online on March 30, 2007
Chest, doi:10.1378/chest.06-2118
A more recent version of this article appeared on September 1, 2007
This Article
Right arrow Full Text (PDF) Free
Right arrow All Versions of this Article:
chest.06-2118v1
132/3/757    most recent
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Article Archive
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Rubenfire, M.
Right arrow Articles by Schilz, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Rubenfire, M.
Right arrow Articles by Schilz, R.
Related Content
Right arrowRelated Editorial

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

Melvyn Rubenfire, MD1; Vallerie V. McLaughlin, MD1; Roblee P. Allen, MD2; Greg Elliott, MD3; Myung H. Park, MD4; Michael Wade, PhD5 and Robert Schilz, DO, PhD6

1University of Michigan Health System, Ann Arbor, MI 2UC Davis Medical Center, Sacramento, CA 3LDS Hospital and the University of Utah, Salt Lake City, UT 4University of Maryland School of Medicine, Baltimore, MD 5United Therapeutics Corp., Research Triangle Park, NC, and 6University Hospitals of Cleveland, Cleveland, OH

mrubenfi{at}umich.edu

Abstract

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

Key Words: pulmonary hypertension • prostacyclin • withdrawal trial


Related Editorial

Transition From IV to Subcutaneous Prostacyclin: Premature Withdrawal?
Shelley Shapiro and Nicholas S. Hill
Chest 2007 132: 741-743. [Full Text] [PDF]





HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
Copyright © 2007 by the American College of Chest Physicians.