Document Detail


Pulmonary arterial hypertension therapy may be safe and effective in patients with systemic sclerosis and borderline pulmonary artery pressure.
MedLine Citation:
PMID:  22127844     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Borderline pulmonary arterial hypertension (PAH), characterized by a marked exercise-induced increase in pulmonary artery pressure (PAP) with normal resting values, may precede overt PAH in systemic sclerosis (SSc). We undertook the present study to investigate whether PAH treatment is safe in these patients and might attenuate hemodynamic progression.
METHODS: SSc patients with borderline PAH underwent right heart catheterization at baseline, after a 12-month observation period, and subsequently after 6 months of bosentan therapy. Changes in mean PAP at 50W during the observation period versus during therapy were compared.
RESULTS: Ten patients completed the study. Mean PAP at rest, at 50W, and during maximal exercise increased significantly during the observation period (mean ± SD increases of 2.5 ± 3.0 mm Hg [P = 0.03], 4.0 ± 2.9 mm Hg [P = 0.002], and 6.8 ± 4.1 mm Hg [P = 0.0005], respectively) and tended to decrease during the treatment period (decreases of 2.5 ± 3.9 mm Hg [P = 0.07], 1.5 ± 4.5 mm Hg [P = 0.32], and 1.8 ± 7.0 mm Hg [P = 0.43], respectively). The changes during the observation period versus the therapy period were significantly different (P = 0.03 at rest, P = 0.01 at 50W [primary end point], and P = 0.02 during maximal exercise). The changes in resting pulmonary vascular resistance were also significantly different during the observation period (increase of 8 ± 25 dynes · seconds · cm(-5) ) versus during the therapy period (decrease of 45 ± 22 dynes · seconds · cm(-5) ) (P < 0.0005). Changes in resting pulmonary arterial wedge pressure were not significantly different between the observation period and the treatment period, despite the significant increase during the observation period (2.6 ± 2.5 mm Hg [P = 0.01]). No relevant adverse effects were reported.
CONCLUSION: In SSc patients with borderline abnormal pulmonary hemodynamics, resting and exercise PAP may increase significantly within 1 year of observation. Bosentan might be safe and effective to attenuate these changes. Randomized controlled trials are warranted to confirm the exploratory findings of this hypothesis-generating pilot study.
Authors:
Gabor Kovacs; Robert Maier; Elisabeth Aberer; Marianne Brodmann; Winfried Graninger; Xhylsime Kqiku; Stefan Scheidl; Natascha Tröster; Christian Hesse; Lewis Rubin; Horst Olschewski
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-11-11
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  64     ISSN:  1529-0131     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-03-29     Completed Date:  2012-09-14     Revised Date:  2013-06-18    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1257-62     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 by the American College of Rheumatology.
Affiliation:
Medical University of Graz, Graz, Austria. gabor.kovacs@klinikum-graz.at
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00909337
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antihypertensive Agents / adverse effects*
Cardiac Catheterization / adverse effects*
Exercise Test
Humans
Hypertension, Pulmonary / complications,  drug therapy*
Middle Aged
Pilot Projects
Scleroderma, Systemic / complications*
Sulfonamides / adverse effects*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Sulfonamides; Q326023R30/bosentan

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


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