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Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
RL. Benza, HA. Ghofrani, E. Grünig, MM. Hoeper, P. Jansa, ZC. Jing, NH. Kim, D. Langleben, G. Simonneau, C. Wang, D. Busse, C. Meier, S. Ghio
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- aktivátory enzymů aplikace a dávkování MeSH
- dospělí MeSH
- funkce pravé komory srdeční účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- plicní embolie komplikace MeSH
- plicní hypertenze farmakoterapie etiologie patofyziologie MeSH
- pyrazoly aplikace a dávkování MeSH
- pyrimidiny aplikace a dávkování MeSH
- síňový tlak účinky léků MeSH
- tepový objem fyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: In the Phase III PATENT-1 (NCT00810693) and CHEST-1 (NCT00855465) studies, riociguat demonstrated efficacy vs placebo in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Clinical effects were maintained at 2 years in the long-term extension studies PATENT-2 (NCT00863681) and CHEST-2 (NCT00910429). METHODS: This post hoc analysis of hemodynamic data from PATENT-1 and CHEST-1 assessed whether riociguat improved right ventricular (RV) function parameters including stroke volume index (SVI), stroke volume, RV work index, and cardiac efficiency. REVEAL Risk Score (RRS) was calculated for patients stratified by SVI and right atrial pressure (RAP) at baseline and follow-up. The association between RV function parameters and SVI and RAP stratification with long-term outcomes was assessed. RESULTS: In PATENT-1 (n = 341) and CHEST-1 (n = 238), riociguat improved RV function parameters vs placebo (p < 0.05). At follow-up, there were significant differences in RRS between patients with favorable and unfavorable SVI and RAP, irrespective of treatment arm (p < 0.0001). Multiple RV function parameters at baseline and follow-up were associated with survival and clinical worsening-free survival (CWFS) in PATENT-2 (n = 396; p < 0.05) and CHEST-2 (n = 237). In PATENT-2, favorable SVI and RAP at follow-up only was associated with survival and CWFS (p < 0.05), while in CHEST-2, favorable SVI and RAP at baseline and follow-up were associated with survival and CWFS (p < 0.05). CONCLUSION: This post hoc analysis of PATENT and CHEST suggests that riociguat improves RV function in patients with PAH and CTEPH.
Chinese Academy of Medical Sciences Peking Union Medica Beijing China
Department of Medicine Imperial College London London UK
Department of Pneumology Kerckhoff Klinik Bad Nauheim Germany
Division of Cardiology Fondazione IRCCS Policlinico S Matteo Pavia Italy
Division of Cardiovascular Medicine The Ohio State University Wexner Medical Center Ohio USA
Employee of Chrestos Concept GmbH and Co KG Essen Germany
Global Medical Affairs Bayer AG Berlin Germany
INSERM UMR_S999 LabEx LERMIT Hôpital Marie Lannelongue Le Plessis Robinson France
Institute of Respiratory Medicine Chinese Academy of Medical Sciences Beijing China
National Clinical Research Center for Respiratory Diseases Beijing China
University of Giessen and Marburg Lung Center German Center of Lung Research Giessen Germany
WHO Collaboration Center for Tobacco Cessation and Respiratory Diseases Prevention Beijing China
Citace poskytuje Crossref.org
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- $a Benza, Raymond L $u Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Ohio, USA. Electronic address: Raymond.benza@osumc.edu
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- $a Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension / $c RL. Benza, HA. Ghofrani, E. Grünig, MM. Hoeper, P. Jansa, ZC. Jing, NH. Kim, D. Langleben, G. Simonneau, C. Wang, D. Busse, C. Meier, S. Ghio
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- $a BACKGROUND: In the Phase III PATENT-1 (NCT00810693) and CHEST-1 (NCT00855465) studies, riociguat demonstrated efficacy vs placebo in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Clinical effects were maintained at 2 years in the long-term extension studies PATENT-2 (NCT00863681) and CHEST-2 (NCT00910429). METHODS: This post hoc analysis of hemodynamic data from PATENT-1 and CHEST-1 assessed whether riociguat improved right ventricular (RV) function parameters including stroke volume index (SVI), stroke volume, RV work index, and cardiac efficiency. REVEAL Risk Score (RRS) was calculated for patients stratified by SVI and right atrial pressure (RAP) at baseline and follow-up. The association between RV function parameters and SVI and RAP stratification with long-term outcomes was assessed. RESULTS: In PATENT-1 (n = 341) and CHEST-1 (n = 238), riociguat improved RV function parameters vs placebo (p < 0.05). At follow-up, there were significant differences in RRS between patients with favorable and unfavorable SVI and RAP, irrespective of treatment arm (p < 0.0001). Multiple RV function parameters at baseline and follow-up were associated with survival and clinical worsening-free survival (CWFS) in PATENT-2 (n = 396; p < 0.05) and CHEST-2 (n = 237). In PATENT-2, favorable SVI and RAP at follow-up only was associated with survival and CWFS (p < 0.05), while in CHEST-2, favorable SVI and RAP at baseline and follow-up were associated with survival and CWFS (p < 0.05). CONCLUSION: This post hoc analysis of PATENT and CHEST suggests that riociguat improves RV function in patients with PAH and CTEPH.
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