European Respiratory Journal最新文献

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Implementation of European National Driving Regulations for Obstructive Sleep Apnoea: challenges and recommendations. 对阻塞性睡眠呼吸暂停的欧洲国家驾驶法规的实施:挑战和建议。
IF 24.3 1区 医学
European Respiratory Journal Pub Date : 2025-05-08 DOI: 10.1183/13993003.02484-2024
Walter T McNicholas,Ysbrand D van der Werf,Sarah Hartley,Pierre Philip,
{"title":"Implementation of European National Driving Regulations for Obstructive Sleep Apnoea: challenges and recommendations.","authors":"Walter T McNicholas,Ysbrand D van der Werf,Sarah Hartley,Pierre Philip,","doi":"10.1183/13993003.02484-2024","DOIUrl":"https://doi.org/10.1183/13993003.02484-2024","url":null,"abstract":"BACKGROUNDObstructive sleep apnoea (OSA) carries an increased risk of motor vehicle accidents (MVA), which resulted in the European Commission introducing a legal directive (2014/85/EU) restricting driving in patients with moderate/severe OSA and sleepiness, unless effectively treated. We assessed the implementation of the directive in European Union (EU) member and non-member states.METHODSNational Sleep Societies and/or selected other sleep specialists in EU member states and selected other European countries completed a questionnaire on the local introduction of the EU Directive, or similar, the OSA severity to restrict driving, criteria to resume driving, and the validity period for different driving licences.RESULTSData were obtained from 25 of 27 EU member states and all 8 non-member states included, representing a population of ∼770 million. All EU members had introduced the Directive into national regulations, largely unchanged, although some countries applied stricter criteria such as mild OSA and a minimum treatment period before resuming driving. Only 5 non-member states had driving regulations for OSA. Problems with implementation of regulations were reported in most countries, including inadequate resources to diagnose/treat OSA patients, excessive restrictions regarding disease severity and certification to resume driving, and under-reporting of symptoms by patients fearing the loss of their licence, especially professional drivers.CONCLUSIONSDriving regulations for OSA apply in most European countries but excessively strict criteria for OSA severity, sleepiness, and delayed permission to resume driving are questionable. Further research is needed on whether such regulations result in fewer accidents and on the objective identification of sleepiness.","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":"39 1","pages":""},"PeriodicalIF":24.3,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143926295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transcriptomic profiling of the airway epithelium in COPD links airway eosinophilia to type 2 inflammation and corticosteroid response. COPD患者气道上皮的转录组学分析将气道嗜酸性粒细胞增多与2型炎症和皮质类固醇反应联系起来。
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.01875-2024
Clarus Leung, Hye Yun Park, Xuan Li, Graeme J Koelwyn, Josie Tuong, Seyed Milad Vahedi, Fernando Sergio Leitao Filho, Julia S Yang, Rachel L Eddy, Stephen Milne, Min Hyung Ryu, Hiroto Takiguchi, Kentaro Akata, Seung Won Ra, Ji-Yong Moon, Hyun Kuk Kim, Yuji Cho, Kei Yamasaki, Stephan F van Eeden, Tawimas Shaipanich, Stephen Lam, Janice M Leung, Don D Sin
{"title":"Transcriptomic profiling of the airway epithelium in COPD links airway eosinophilia to type 2 inflammation and corticosteroid response.","authors":"Clarus Leung, Hye Yun Park, Xuan Li, Graeme J Koelwyn, Josie Tuong, Seyed Milad Vahedi, Fernando Sergio Leitao Filho, Julia S Yang, Rachel L Eddy, Stephen Milne, Min Hyung Ryu, Hiroto Takiguchi, Kentaro Akata, Seung Won Ra, Ji-Yong Moon, Hyun Kuk Kim, Yuji Cho, Kei Yamasaki, Stephan F van Eeden, Tawimas Shaipanich, Stephen Lam, Janice M Leung, Don D Sin","doi":"10.1183/13993003.01875-2024","DOIUrl":"10.1183/13993003.01875-2024","url":null,"abstract":"<p><strong>Background: </strong>A subset of COPD patients have high levels of eosinophils in the distal airways (\"airway eosinophilia\").</p><p><strong>Objectives: </strong>To compare the gene expression of type 2 inflammation in airway epithelial brushings of COPD patients with and without airway eosinophilia and to investigate the changes after inhaled corticosteroids (ICS).</p><p><strong>Methods: </strong><i>Post hoc</i> analyses of the DISARM randomised controlled trial investigated the expression of airway inflammation (type 1, 2 and 17), interleukin (IL)-13 and mast cell gene signatures at baseline and after 12-week ICS treatment. Gene signatures were generated from RNA sequencing of airway epithelial brushings. Airway eosinophilia was defined as eosinophils >1% of the total leukocyte count in bronchoalveolar lavage. Gene set enrichment analyses identified upregulated canonical pathways in airway eosinophilia.</p><p><strong>Results: </strong>Among 58 COPD patients, 38% had airway eosinophilia at baseline. Patients with airway eosinophilia had more severe airflow obstruction and more radiographic emphysema than the non-eosinophilia group. Patients with airway eosinophilia showed a higher epithelial expression of type 2 airway inflammation and IL-13 and mast cell activation at baseline, but the expression of type 1 and type 17 airway inflammation was similar to patients without airway eosinophilia. The airway eosinophilia group showed an upregulation of canonical pathways related to type 2 immune response and asthma. Treatment with ICS for 12 weeks reduced the epithelial expression of type 2 inflammation and mast cell gene signatures in patients with airway eosinophilia, while this change was not significant in patients without airway eosinophilia.</p><p><strong>Conclusions: </strong>Airway eosinophilia marks a subset of COPD patients with increased airway epithelial expression of type 2 inflammation and a response to ICS treatment.</p>","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Heart rate response and cardiovascular risk during obstructive sleep apnoea: an easy biomarker derived from pulse oximetry. 呼吸暂停期间的心率反应和心血管风险:从脉搏血氧测定中获得的简单生物标志物。
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.01883-2024
Margaux Blanchard, Théo Imler, Wen-Hsin Hu, Adrien Waeber, Geoffroy Solelhac, José Haba-Rubio, Sandrine Kerbrat, Abdelkebir Sabil, Wojciech Trzepizur, François Goupil, Audrey Thomas, Sébastien Bailly, Ali Azarbarzin, Peter Vollenweider, Pedro Marques-Vidal, Julien Vaucher, Raphael Heinzer, Frédéric Gagnadoux
{"title":"Heart rate response and cardiovascular risk during obstructive sleep apnoea: an easy biomarker derived from pulse oximetry.","authors":"Margaux Blanchard, Théo Imler, Wen-Hsin Hu, Adrien Waeber, Geoffroy Solelhac, José Haba-Rubio, Sandrine Kerbrat, Abdelkebir Sabil, Wojciech Trzepizur, François Goupil, Audrey Thomas, Sébastien Bailly, Ali Azarbarzin, Peter Vollenweider, Pedro Marques-Vidal, Julien Vaucher, Raphael Heinzer, Frédéric Gagnadoux","doi":"10.1183/13993003.01883-2024","DOIUrl":"10.1183/13993003.01883-2024","url":null,"abstract":"<p><strong>Background: </strong>Sleep apnoea-specific heart rate response (ΔHR) has been identified as a promising biomarker for stratifying cardiovascular (CV) risk and predicting positive airway pressure (PAP) benefit in obstructive sleep apnoea (OSA). However, the need for prior manual scoring of respiratory events potentially limits the accessibility and reproducibility of ΔHR. We aimed to evaluate the association of pulse rate response to oxygen desaturations automatically derived from pulse oximetry (ΔHR<sub>oxi</sub>) with CV risk in OSA.</p><p><strong>Methods: </strong>ΔHR<sub>oxi</sub> and ΔHR were measured in OSA patients from the Institut de Recherche en Santé Respiratoire Pays de la Loire Sleep Cohort (PLSC; n=5002) and the HypnoLaus cohort (n=1307). The primary outcome was major adverse CV events (MACEs), a composite of mortality, stroke and cardiac diseases. Cox regression analyses were conducted to evaluate the association of ΔHR<sub>oxi</sub> and ΔHR, categorised into low, midrange and high categories, with MACEs.</p><p><strong>Results: </strong>MACEs occurred in 768 patients from PLSC and 87 patients from HypnoLaus (median follow-up 8.0 and 7.5 years, respectively). Multivariable Cox models showed that subjects with high ΔHR<sub>oxi</sub> (<i>versus</i> midrange) had higher risk of MACEs in PLSC (hazard ratio (HR) 1.42, 95% CI 1.18-1.71) and HypnoLaus (HR 1.72, 95% CI 1.03-2.87). Similar findings were observed for high ΔHR. Among 2718 patients from PLSC treated with PAP, the association of PAP adherence (PAP use ≥4 h·night<sup>-1</sup> <i>versus</i> non-adherent) with MACEs was modified by baseline ΔHR and ΔHR<sub>oxi</sub> (p<sub>interaction</sub><0.05).</p><p><strong>Conclusion: </strong>ΔHR<sub>oxi</sub> could constitute a reliable and easy to measure biomarker for stratifying CV risk and predicting CV benefit of PAP in OSA.</p>","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reply to: Unravelling the physiology of exercise pulmonary hypertension in patients with heart failure with preserved ejection fraction. 对保留射血分数的心力衰竭患者运动性肺动脉高压的生理学研究。
IF 24.3 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 DOI: 10.1183/13993003.00543-2025
Bryce N Balmain,Tony G Babb
{"title":"Reply to: Unravelling the physiology of exercise pulmonary hypertension in patients with heart failure with preserved ejection fraction.","authors":"Bryce N Balmain,Tony G Babb","doi":"10.1183/13993003.00543-2025","DOIUrl":"https://doi.org/10.1183/13993003.00543-2025","url":null,"abstract":"","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":"1 1","pages":""},"PeriodicalIF":24.3,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pulmonary arterial hypertension and targeting pulmonary vascular remodelling: are we there yet? 肺动脉高压和靶向肺血管重构:我们做到了吗?
IF 24.3 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 DOI: 10.1183/13993003.00322-2025
James Lordan,Jason Weatherald
{"title":"Pulmonary arterial hypertension and targeting pulmonary vascular remodelling: are we there yet?","authors":"James Lordan,Jason Weatherald","doi":"10.1183/13993003.00322-2025","DOIUrl":"https://doi.org/10.1183/13993003.00322-2025","url":null,"abstract":"","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":"14 1","pages":""},"PeriodicalIF":24.3,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rethinking pulmonary arterial hypertension care: the role of dual therapy in patients with cardiovascular comorbidities. 肺动脉高压护理的再思考:双重治疗在心血管合并症患者中的作用。
IF 24.3 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 DOI: 10.1183/13993003.00273-2025
Clara Hjalmarsson,Sandeep Sahay
{"title":"Rethinking pulmonary arterial hypertension care: the role of dual therapy in patients with cardiovascular comorbidities.","authors":"Clara Hjalmarsson,Sandeep Sahay","doi":"10.1183/13993003.00273-2025","DOIUrl":"https://doi.org/10.1183/13993003.00273-2025","url":null,"abstract":"","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":"68 1","pages":""},"PeriodicalIF":24.3,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preventing oxygen desaturation during bronchoscopy in COPD patients using high-flow oxygen versus standard management: the randomised controlled PROSA 2 trial. 在COPD患者支气管镜检查期间,使用高流量氧与标准管理相比较,预防氧去饱和:随机对照PROSA 2试验
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.01586-2024
Andrei M Darie, Leticia Grize, Kathleen Jahn, Anna Salina, Jonathan Röcken, Matthias J Herrmann, Maria Pascarella, Vivian Suarez, Werner Strobel, Michael Tamm, Daiana Stolz
{"title":"Preventing oxygen desaturation during bronchoscopy in COPD patients using high-flow oxygen <i>versus</i> standard management: the randomised controlled PROSA 2 trial.","authors":"Andrei M Darie, Leticia Grize, Kathleen Jahn, Anna Salina, Jonathan Röcken, Matthias J Herrmann, Maria Pascarella, Vivian Suarez, Werner Strobel, Michael Tamm, Daiana Stolz","doi":"10.1183/13993003.01586-2024","DOIUrl":"10.1183/13993003.01586-2024","url":null,"abstract":"<p><strong>Background: </strong>Patients with COPD are at increased risk for developing additional respiratory comorbidities associated with smoking, and are thus prone to undergo flexible bronchoscopy. However, COPD patients have increased periprocedural complications risk and lower oxygen saturation during bronchoscopy.</p><p><strong>Methods: </strong>This was an investigator-initiated, single-centre, open-label randomised controlled trial designed to assess the benefits of high-flow nasal oxygen compared to conventional low-flow oxygen by nasal cannula during conscious sedation for bronchoscopy in patients with COPD. Low flow was supplied at a starting rate of 4 L·min<sup>-1</sup> and gradually increased up to 12 L·min<sup>-1</sup> to maintain peripheral oxygen saturation (<i>S</i> <sub>pO<sub>2</sub></sub> ) >90%. High flow delivered starting at a rate of 60 L·min<sup>-1</sup> and an inspiratory oxygen fraction of 0.6 was increased up to 80 L·min<sup>-1</sup> to preserve <i>S</i> <sub>pO<sub>2</sub></sub> >90%. The primary end-point was cumulative hypoxaemia time.</p><p><strong>Results: </strong>We randomised 600 COPD cases with a median (interquartile range (IQR)) age of 69.0 (62.0-76.0) years to either high flow (n=295) or low flow (n=305). The cumulative hypoxaemia time was 53% lower in the high-flow group (1.8% (95% CI 1.5-2.2%) <i>versus</i> 3.8% (95% CI 3.2-4.5%) of monitoring time; p<0.001). Additionally, the high-flow group experienced a median (IQR) of 3.0 (1.0-6.0) hypoxaemia events (<i>S</i> <sub>pO<sub>2</sub></sub> <90%) compared to 6.0 (3.0-10.0) in the low-flow group (p<0.001). The low-flow group had five-fold higher odds of experiencing hypoxaemia during bronchoscopy, (OR 5.1, 95% CI 3.2-8.2; p<0.001).</p><p><strong>Conclusion: </strong>High flow is feasible, decreases cumulative hypoxaemia time and reduces hypoxaemia events during bronchoscopy in patients with COPD but does not impact patient comfort.</p>","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Eosinophils in COPD type 2 inflammation: hope or hype? 嗜酸性粒细胞与慢性阻塞性肺病2型炎症:希望还是炒作?
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.00194-2025
Francesca Polverino, MeiLan K Han
{"title":"Eosinophils in COPD type 2 inflammation: hope or hype?","authors":"Francesca Polverino, MeiLan K Han","doi":"10.1183/13993003.00194-2025","DOIUrl":"10.1183/13993003.00194-2025","url":null,"abstract":"","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Initial therapy in patients with pulmonary arterial hypertension and cardiovascular comorbidities. 肺动脉高压合并心血管合并症患者的初始治疗。
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.00895-2024
Athénaïs Boucly, David Montani, Fabrice Bauer, Elise Artaud-Macari, Emmanuel Bergot, Clément Boissin, Ari Chaouat, Vincent Cottin, Claire Dauphin, Bruno Degano, Pascal De Groote, Camille du Roure, Nicolas Favrolt, Delphine Horeau-Langlard, Xavier Jaïs, Mitja Jevnikar, Thomas Lacoste-Palasset, François Picard, Grégoire Prévôt, Martine Reynaud-Gaubert, Anne Roche, Ségolène Turquier, Marc Humbert, Olivier Sitbon, Laurent Savale
{"title":"Initial therapy in patients with pulmonary arterial hypertension and cardiovascular comorbidities.","authors":"Athénaïs Boucly, David Montani, Fabrice Bauer, Elise Artaud-Macari, Emmanuel Bergot, Clément Boissin, Ari Chaouat, Vincent Cottin, Claire Dauphin, Bruno Degano, Pascal De Groote, Camille du Roure, Nicolas Favrolt, Delphine Horeau-Langlard, Xavier Jaïs, Mitja Jevnikar, Thomas Lacoste-Palasset, François Picard, Grégoire Prévôt, Martine Reynaud-Gaubert, Anne Roche, Ségolène Turquier, Marc Humbert, Olivier Sitbon, Laurent Savale","doi":"10.1183/13993003.00895-2024","DOIUrl":"10.1183/13993003.00895-2024","url":null,"abstract":"<p><strong>Background: </strong>European guidelines recommend initial monotherapy in pulmonary arterial hypertension patients with cardiovascular comorbidities based on the limited evidence for combination therapy in this growing population.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on incident pulmonary arterial hypertension patients enrolled in the French Pulmonary Hypertension Registry between 2009 and 2020. Propensity score matching was used to investigate initial dual oral combination therapy <i>versus</i> oral monotherapy in patients with at least one cardiovascular comorbidity (<i>i.e.</i> hypertension, obesity, diabetes and coronary artery disease).</p><p><strong>Results: </strong>Of the 1784 patients identified, 1088 had at least one cardiovascular comorbidity, including 20% with three or comorbidities. In the propensity score-matched population (n=708), the majority of patients were female, with idiopathic/heritable/drug-induced pulmonary arterial hypertension at intermediate 1-year mortality risk. At first follow-up, initial dual therapy led to larger improvements in symptoms, exercise capacity, haemodynamic parameters and risk status than initial monotherapy, with no differences in long‑term survival. Treatment discontinuation was observed in 23% of patients initiated on dual therapy and 24% of those initiated on monotherapy.</p><p><strong>Conclusions: </strong>Initial dual oral combination therapy may be beneficial and well-tolerated in most pulmonary arterial hypertension patients with cardiovascular comorbidities.</p>","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies. 激活素信号抑制剂sotaterept的有效性和安全性:PULSAR和STELLAR研究的汇总分析
IF 16.6 1区 医学
European Respiratory Journal Pub Date : 2025-05-06 Print Date: 2025-05-01 DOI: 10.1183/13993003.01424-2024
Marius M Hoeper, Mardi Gomberg-Maitland, David B Badesch, J Simon R Gibbs, Ekkehard Grünig, Grzegorz Kopeć, Vallerie V McLaughlin, Gisela Meyer, Karen M Olsson, Ioana R Preston, Stephan Rosenkranz, Rogerio Souza, Aaron B Waxman, Loïc Perchenet, James Strait, Aiwen Xing, Solaiappan Manimaran, Xuelong Wang, Barry Miller, Alexandra G Cornell, Janethe de Oliveira Pena, H Ardeschir Ghofrani, Marc Humbert
{"title":"Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies.","authors":"Marius M Hoeper, Mardi Gomberg-Maitland, David B Badesch, J Simon R Gibbs, Ekkehard Grünig, Grzegorz Kopeć, Vallerie V McLaughlin, Gisela Meyer, Karen M Olsson, Ioana R Preston, Stephan Rosenkranz, Rogerio Souza, Aaron B Waxman, Loïc Perchenet, James Strait, Aiwen Xing, Solaiappan Manimaran, Xuelong Wang, Barry Miller, Alexandra G Cornell, Janethe de Oliveira Pena, H Ardeschir Ghofrani, Marc Humbert","doi":"10.1183/13993003.01424-2024","DOIUrl":"10.1183/13993003.01424-2024","url":null,"abstract":"<p><strong>Introduction: </strong>Pulmonary arterial hypertension is a progressive disease associated with significant morbidity and mortality. Sotatercept is a first-in-class activin signalling inhibitor that acts to restore the balance between the growth-promoting and growth-inhibiting signalling pathways.</p><p><strong>Methods: </strong>This <i>post hoc</i>, exploratory, pooled analysis combines data from the double-blind placebo periods of the phase 2 PULSAR (NCT03496207) and phase 3 STELLAR (NCT04576988) studies. Both studies were international, multicentre, randomised, double-blind, placebo-controlled trials in patients with pulmonary arterial hypertension. Efficacy and safety parameters common to both studies were analysed.</p><p><strong>Results: </strong>A total of 429 patients were randomised and treated; 237 received sotatercept and 192 received placebo. Adding sotatercept to background pulmonary arterial hypertension therapy for 24 weeks improved exercise capacity (as assessed by 6-min walk distance), pulmonary vascular resistance and World Health Organization functional class, and delayed time to first occurrence of death or clinical worsening event. There were clinically important reductions in both pulmonary and right heart pressures; improvements in right ventricle size during both systole and diastole; and enhancements in right ventricle contractility and right ventricular-pulmonary artery coupling. The number of patients who experienced at least one adverse event of interest or special interest (increased haemoglobin, thrombocytopenia, bleeding events (mostly epistaxis), increased blood pressure and telangiectasia) was higher in the sotatercept group than the placebo group.</p><p><strong>Conclusion: </strong>This pooled analysis confirms that sotatercept delivers therapeutic benefit across a range of efficacy end-points and has favourable safety in patients with pulmonary arterial hypertension. Increased duration of follow-up will provide further insight into long-term outcomes of sotatercept in patients with pulmonary arterial hypertension.</p>","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":" ","pages":""},"PeriodicalIF":16.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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