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Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension
NH. Kim, AM. D'Armini, F. Grimminger, E. Grünig, MM. Hoeper, P. Jansa, E. Mayer, C. Neurohr, G. Simonneau, A. Torbicki, C. Wang, A. Fritsch, N. Davie, HA. Ghofrani,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie
NLK
ProQuest Central
od 1996-01-01 do Před 3 měsíci
Health & Medicine (ProQuest)
od 1996-01-01 do Před 3 měsíci
- MeSH
- antihypertenziva škodlivé účinky terapeutické užití MeSH
- arteria pulmonalis účinky léků patofyziologie MeSH
- arteriální tlak účinky léků MeSH
- časové faktory MeSH
- cévní rezistence účinky léků MeSH
- chronická nemoc MeSH
- dvojitá slepá metoda MeSH
- endarterektomie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metoda nejmenších čtverců MeSH
- obnova funkce MeSH
- plicní embolie komplikace diagnóza MeSH
- plicní hypertenze diagnóza farmakoterapie etiologie patofyziologie MeSH
- prospektivní studie MeSH
- pyrazoly škodlivé účinky terapeutické užití MeSH
- pyrimidiny škodlivé účinky terapeutické užití MeSH
- recidiva MeSH
- senioři MeSH
- test chůzí MeSH
- tolerance zátěže účinky léků MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: We compared the haemodynamic effects of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent/recurrent CTEPH after pulmonary endarterectomy in the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase-Stimulator Trial 1 study. METHODS: Patients with inoperable or persistent/recurrent CTEPH (n=261; mean± SD age 59±14 years; 66% women) were randomised to riociguat (up to 2.5 mg three times daily) or placebo. Haemodynamic parameters were assessed at baseline and week 16. RESULTS: Riociguat decreased pulmonary vascular resistance (PVR) in inoperable (n=189; least-squares mean difference: -285 dyn s/cm(5) (95% CI -357 to -213); p<0.0001) and persistent/recurrent (n=72; -131 dyn s/cm(5) (95% CI -214 to -48); p=0.0025) patients. Cardiac index improved in inoperable patients by a least-squares mean difference of +0.6 L/min/m(2) (95% CI 0.4 to 0.7; p<0.0001), while in persistent/recurrent patients the change was +0.2 L/min/m(2) (95% CI -0.1 to 0.5; p=0.17). Mean pulmonary artery pressure decreased in inoperable and persistent/recurrent patients(-4.7 mm Hg (95% CI -6.9 to -2.6; p<0.0001 and -4.8 mm Hg (-8.2 to -1.5; p=0.0055), respectively). For all patients, changes in 6 min walk distance correlated with changes in PVR (r=-0.29 (95% CI -0.41 to -0.17); p<0.0001) and cardiac index (r=0.23 (95% CI 0.10 to 0.35); p=0.0004). CONCLUSIONS: Riociguat improved haemodynamics in patients with inoperable CTEPH or persistent/recurrent CTEPH. TRIAL REGISTRATION NUMBER: NCT00855465.
Center for Pulmonary Hypertension Thoraxclinic University Hospital Heidelberg Heidelberg Germany
Division of Pulmonary Diseases Ludwig Maximilians University Munich Germany
Global Clinical Development Bayer Pharma AG Wuppertal Germany
Kerckhoff Heart and Lung Center Bad Nauheim Germany
University of Giessen and Marburg Lung Center Giessen Germany
Citace poskytuje Crossref.org
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- $a Kim, Nick H $u Division of Pulmonary and Critical Care Medicine, University of California, San Diego, La Jolla, California, USA.
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- $a Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension / $c NH. Kim, AM. D'Armini, F. Grimminger, E. Grünig, MM. Hoeper, P. Jansa, E. Mayer, C. Neurohr, G. Simonneau, A. Torbicki, C. Wang, A. Fritsch, N. Davie, HA. Ghofrani,
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- $a OBJECTIVE: We compared the haemodynamic effects of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent/recurrent CTEPH after pulmonary endarterectomy in the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase-Stimulator Trial 1 study. METHODS: Patients with inoperable or persistent/recurrent CTEPH (n=261; mean± SD age 59±14 years; 66% women) were randomised to riociguat (up to 2.5 mg three times daily) or placebo. Haemodynamic parameters were assessed at baseline and week 16. RESULTS: Riociguat decreased pulmonary vascular resistance (PVR) in inoperable (n=189; least-squares mean difference: -285 dyn s/cm(5) (95% CI -357 to -213); p<0.0001) and persistent/recurrent (n=72; -131 dyn s/cm(5) (95% CI -214 to -48); p=0.0025) patients. Cardiac index improved in inoperable patients by a least-squares mean difference of +0.6 L/min/m(2) (95% CI 0.4 to 0.7; p<0.0001), while in persistent/recurrent patients the change was +0.2 L/min/m(2) (95% CI -0.1 to 0.5; p=0.17). Mean pulmonary artery pressure decreased in inoperable and persistent/recurrent patients(-4.7 mm Hg (95% CI -6.9 to -2.6; p<0.0001 and -4.8 mm Hg (-8.2 to -1.5; p=0.0055), respectively). For all patients, changes in 6 min walk distance correlated with changes in PVR (r=-0.29 (95% CI -0.41 to -0.17); p<0.0001) and cardiac index (r=0.23 (95% CI 0.10 to 0.35); p=0.0004). CONCLUSIONS: Riociguat improved haemodynamics in patients with inoperable CTEPH or persistent/recurrent CTEPH. TRIAL REGISTRATION NUMBER: NCT00855465.
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