| Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. | |
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MedLine Citation:
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PMID: 17012628 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Addition of inhaled iloprost to bosentan may have beneficial effects in patients with idiopathic pulmonary arterial hypertension (IPAH). A multicentre, open, randomised, controlled trial was performed to assess the safety and efficacy of inhaled iloprost in patients with IPAH who had already been treated with bosentan. The trial was terminated early after a futility analysis predicted failure with respect to the predetermined sample size. At that time, 40 patients were randomised to receive either bosentan alone (control group) or bosentan plus inhaled iloprost (combination group) for a 12-week period. The primary end-point, change in 6-min walking distance, was not met (mean changes +1 m and -9 m in the control and combination group, respectively). These results may have been skewed by three outliers in the iloprost group who presented with severe clinical worsening. None of the secondary end-points including functional class, peak oxygen uptake, and time to clinical worsening differed significantly between groups. The current study failed to show a positive effect of adding inhaled iloprost to bosentan in idiopathic pulmonary arterial hypertension patients. Further studies involving larger sample sizes and long-term follow-up are needed to determine the efficacy of adding inhaled iloprost to bosentan in patients with idiopathic pulmonary arterial hypertension. |
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Authors:
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M M Hoeper; H Leuchte; M Halank; H Wilkens; F J Meyer; H J Seyfarth; R Wensel; F Ripken; H Bremer; S Kluge; G Hoeffken; J Behr |
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Publication Detail:
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Type: Clinical Trial, Phase IV; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology Volume: 28 ISSN: 0903-1936 ISO Abbreviation: Eur. Respir. J. Publication Date: 2006 Oct |
Date Detail:
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Created Date: 2006-10-02 Completed Date: 2007-02-01 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8803460 Medline TA: Eur Respir J Country: Switzerland |
Other Details:
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Languages: eng Pagination: 691-4 Citation Subset: IM |
Affiliation:
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Hannover Medical School, Dept of Respiratory Medicine, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. hoeper.marius@mh-hannover.de |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Inhalation Adult Aged Antihypertensive Agents / therapeutic use* Drug Therapy, Combination Exercise Test Female Humans Hypertension, Pulmonary / drug therapy* Iloprost / administration & dosage, adverse effects, therapeutic use* Male Middle Aged Sulfonamides / therapeutic use* Vasodilator Agents / administration & dosage, adverse effects, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Sulfonamides; 0/Vasodilator Agents; 147536-97-8/bosentan; 78919-13-8/Iloprost |
| Comments/Corrections | |
Comment In:
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Eur Respir J. 2006 Oct;28(4):683-6
[PMID:
17012626
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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