Document Detail


Favorable effects of inhaled treprostinil in severe pulmonary hypertension: results from randomized controlled pilot studies.
MedLine Citation:
PMID:  17045906     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This study sought to investigate the effects of inhaled treprostinil on pulmonary hemodynamics and gas exchange in severe pulmonary hypertension. BACKGROUND: Inhaled iloprost therapy has a proven clinical efficacy in pulmonary arterial hypertension, but this therapy necessitates 6 to 9 inhalation sessions per day. Treprostinil has a longer plasma half-life and might provide favorable properties when applied by inhalation. METHODS: Three different studies were conducted on a total of 123 patients by means of right heart catheterization: 1) a randomized crossover-design study (44 patients), 2) a dose escalation study (31 patients), and 3) a study of reduction of inhalation time while keeping the dose fixed (48 patients). The primary end point was the change in pulmonary vascular resistance (PVR). RESULTS: The mean pulmonary arterial pressure of the enrolled patients was approximately 50 mm Hg in all studies. In study 1, both treprostinil and iloprost at an inhaled dose of 7.5 mug displayed a comparable PVR decrease, with a significantly different time course (p < 0.001), treprostinil showing a more sustained effect on PVR (p < 0.0001) and fewer systemic side effects. In study 2, effects of inhalation were observed for 3 h. A near-maximal acute PVR decrease was observed at 30 mug treprostinil. In study 3, treprostinil was inhaled at increasing concentrations with a pulsed ultrasonic nebulizer, mimicking a metered dose inhaler. A dose of 15 mug treprostinil was inhaled with 18, 9, 3, 2 pulses, or 1 pulse, each mode achieving comparable, sustained pulmonary vasodilation without significant side effects. CONCLUSIONS: Inhaled treprostinil exerts sustained pulmonary vasodilation with excellent tolerability at relatively low doses and may be inhaled in a few breaths.
Authors:
Robert Voswinckel; Beate Enke; Frank Reichenberger; Markus Kohstall; Andree Kreckel; Stefanie Krick; Henning Gall; Tobias Gessler; Thomas Schmehl; Hossein A Ghofrani; Ralph Theo Schermuly; Friedrich Grimminger; Lewis J Rubin; Werner Seeger; Horst Olschewski
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-09-26
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  48     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2006 Oct 
Date Detail:
Created Date:  2006-10-18     Completed Date:  2006-11-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1672-81     Citation Subset:  AIM; IM    
Affiliation:
Department of Internal Medicine, University Hospital Giessen, Giessen, Germany.
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Blood Pressure
Cross-Over Studies
Dose-Response Relationship, Drug
Drug Administration Schedule
Epoprostenol / administration & dosage,  analogs & derivatives*,  blood,  therapeutic use
Humans
Hypertension, Pulmonary / blood,  drug therapy*,  physiopathology*
Nebulizers and Vaporizers
Pilot Projects
Pulmonary Artery / physiopathology
Pulmonary Circulation / drug effects
Severity of Illness Index
Single-Blind Method
Ultrasonics
Vascular Resistance / drug effects
Vasodilation / drug effects
Chemical
Reg. No./Substance:
0/treprostinil; 35121-78-9/Epoprostenol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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