Pub Date : 2024-03-01Epub Date: 2024-02-15DOI: 10.1007/s41030-024-00253-3
Ricardo Amorim Correa, Francisco Arancibia, Renato De Ávila Kfouri, Alberto Chebabo, Gabriel García, Luis Miguel Gutiérrez Robledo, Gustavo Lopardo, Julio Nemerovsky, Carlos M Pérez, Adrian Rendon, Guillermo M Ruiz-Palacios, Bhumika Aggarwal, Arnas Berzanskis, Otavio Cintra
Respiratory syncytial virus (RSV) is a significant global health concern and major cause of hospitalization, particularly among infants and older adults. The clinical impact of RSV is well characterized in infants; however, in many countries, the burden and risk of RSV in older populations are overlooked. In Latin America, there are limited data on RSV epidemiology and disease management in older adults. Therefore, the impact of RSV in this region needs to be addressed. Here, current insights on RSV infections in older populations in Latin America, including those with underlying health conditions, are discussed. We also outline the key challenges limiting our understanding of the burden of RSV in Latin America in a worldwide context and propose an expert consensus to improve our understanding of the burden of RSV in the region. By so doing, we aim to ultimately improve disease management and outcomes of those at risk and to alleviate the impact on healthcare systems.A graphical plain language summary is available with this article.
{"title":"Understanding the Burden of Respiratory Syncytial Virus in Older Adults in Latin America: An Expert Perspective on Knowledge Gaps.","authors":"Ricardo Amorim Correa, Francisco Arancibia, Renato De Ávila Kfouri, Alberto Chebabo, Gabriel García, Luis Miguel Gutiérrez Robledo, Gustavo Lopardo, Julio Nemerovsky, Carlos M Pérez, Adrian Rendon, Guillermo M Ruiz-Palacios, Bhumika Aggarwal, Arnas Berzanskis, Otavio Cintra","doi":"10.1007/s41030-024-00253-3","DOIUrl":"10.1007/s41030-024-00253-3","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) is a significant global health concern and major cause of hospitalization, particularly among infants and older adults. The clinical impact of RSV is well characterized in infants; however, in many countries, the burden and risk of RSV in older populations are overlooked. In Latin America, there are limited data on RSV epidemiology and disease management in older adults. Therefore, the impact of RSV in this region needs to be addressed. Here, current insights on RSV infections in older populations in Latin America, including those with underlying health conditions, are discussed. We also outline the key challenges limiting our understanding of the burden of RSV in Latin America in a worldwide context and propose an expert consensus to improve our understanding of the burden of RSV in the region. By so doing, we aim to ultimately improve disease management and outcomes of those at risk and to alleviate the impact on healthcare systems.A graphical plain language summary is available with this article.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139736009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01Epub Date: 2024-01-07DOI: 10.1007/s41030-023-00251-x
Nick H Kim, Kelly M Chin, Vallerie V McLaughlin, Hilary DuBrock, Ricardo Restrepo-Jaramillo, Zeenat Safdar, Gwen MacDonald, Nicolas Martin, Daniel Rosenberg, Maria Solonets, Richard Channick
Introduction: Portopulmonary hypertension (PoPH) carries a worse prognosis than other forms of pulmonary arterial hypertension (PAH). Data regarding use of PAH-specific therapies in patients with PoPH are sparse as they are usually excluded from clinical trials. This analysis describes patient characteristics, treatment patterns, outcomes, and safety profiles in patients with PoPH newly initiating macitentan in the USA using the OPUS/OrPHeUS combined dataset.
Methods: OPUS was a prospective, US, multicenter, observational drug registry (April 2014-June 2020); OrPHeUS was a retrospective, US, multicenter chart review (October 2013-March 2017). Additional information regarding patients' liver disease was retrospectively collected for patients with PoPH in OPUS.
Results: The OPUS/OrPHeUS dataset included 206 patients with PoPH (median age 58 years; 52.4% female), with baseline cirrhosis and liver test abnormalities reported in 72.8% and 31.6% of patients respectively. Macitentan was initiated as combination therapy in 74.8% of patients and median (Q1, Q3) exposure to macitentan was 11.9 (3.1, 26.0) months. One-year Kaplan-Meier estimates (95% confidence limit, CL) of patients free from all-cause hospitalization and survival were 48.6% (40.7, 56.0) and 82.2% (75.1, 87.4). Of the 96 patients with PoPH in OPUS, 29.2% were classified as in need of liver transplant due to underlying liver disease during the study; transplant waitlist registration was precluded because of PAH severity for 32.1% and 17.9% were transplanted. Hepatic adverse events (HAE) were experienced by 49.0% of patients; the most common being increased bilirubin (16.0%), ascites (7.3%), and hepatic encephalopathy (5.8%); 1.5% and 21.8% of patients discontinued macitentan as a result of HAE and non-hepatic adverse events.
Conclusion: There were no unexpected safety findings in patients with PoPH treated with macitentan. These data add to the evidence supporting the safety and tolerability of macitentan in patients with PoPH. A graphical abstract is available with this article.
{"title":"Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies.","authors":"Nick H Kim, Kelly M Chin, Vallerie V McLaughlin, Hilary DuBrock, Ricardo Restrepo-Jaramillo, Zeenat Safdar, Gwen MacDonald, Nicolas Martin, Daniel Rosenberg, Maria Solonets, Richard Channick","doi":"10.1007/s41030-023-00251-x","DOIUrl":"10.1007/s41030-023-00251-x","url":null,"abstract":"<p><strong>Introduction: </strong>Portopulmonary hypertension (PoPH) carries a worse prognosis than other forms of pulmonary arterial hypertension (PAH). Data regarding use of PAH-specific therapies in patients with PoPH are sparse as they are usually excluded from clinical trials. This analysis describes patient characteristics, treatment patterns, outcomes, and safety profiles in patients with PoPH newly initiating macitentan in the USA using the OPUS/OrPHeUS combined dataset.</p><p><strong>Methods: </strong>OPUS was a prospective, US, multicenter, observational drug registry (April 2014-June 2020); OrPHeUS was a retrospective, US, multicenter chart review (October 2013-March 2017). Additional information regarding patients' liver disease was retrospectively collected for patients with PoPH in OPUS.</p><p><strong>Results: </strong>The OPUS/OrPHeUS dataset included 206 patients with PoPH (median age 58 years; 52.4% female), with baseline cirrhosis and liver test abnormalities reported in 72.8% and 31.6% of patients respectively. Macitentan was initiated as combination therapy in 74.8% of patients and median (Q1, Q3) exposure to macitentan was 11.9 (3.1, 26.0) months. One-year Kaplan-Meier estimates (95% confidence limit, CL) of patients free from all-cause hospitalization and survival were 48.6% (40.7, 56.0) and 82.2% (75.1, 87.4). Of the 96 patients with PoPH in OPUS, 29.2% were classified as in need of liver transplant due to underlying liver disease during the study; transplant waitlist registration was precluded because of PAH severity for 32.1% and 17.9% were transplanted. Hepatic adverse events (HAE) were experienced by 49.0% of patients; the most common being increased bilirubin (16.0%), ascites (7.3%), and hepatic encephalopathy (5.8%); 1.5% and 21.8% of patients discontinued macitentan as a result of HAE and non-hepatic adverse events.</p><p><strong>Conclusion: </strong>There were no unexpected safety findings in patients with PoPH treated with macitentan. These data add to the evidence supporting the safety and tolerability of macitentan in patients with PoPH. A graphical abstract is available with this article.</p><p><strong>Trial registration: </strong>OPsumit® Users Registry (OPUS): NCT02126943; OPsumit® Historical Users cohort (OrPHeUS): NCT03197688; www.</p><p><strong>Clinicaltrials: </strong>gov .</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139111169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01Epub Date: 2024-01-09DOI: 10.1007/s41030-023-00249-5
Herbert Wachtel, Rachel Emerson-Stadler, Peter Langguth, Jens M Hohlfeld, Jill Ohar
Introduction: The selection of inhaler device is of critical importance in chronic obstructive pulmonary disease (COPD) as the interaction between a patient's inhalation profile and the aerosol characteristics of an inhaler can affect drug delivery and lung deposition. This study assessed the in vitro aerosol characteristics of inhaler devices approved for the treatment of COPD, including a soft mist inhaler (SMI), pressurized metered-dose inhalers (pMDIs), and dry powder inhalers (DPIs).
Methods: High-speed video recording was used to visualize and measure aerosol velocity and spray duration for nine different inhalers (one SMI, three pMDIs, and five DPIs), each containing dual or triple fixed-dose combinations of long-acting muscarinic receptor antagonists and long-acting β2-agonists, with or without an inhaled corticosteroid. Measurements were taken in triplicate at experimental flow rates of 30, 60, and 90 l/min. Optimal flow rates were defined based on pharmacopoeial testing requirements: 30 l/min for pMDIs and SMIs, and the rate achieving a 4-kPa pressure drop against internal inhaler resistance for DPIs. Comparison of aerosol plumes was based on the experimental flow rates closest to the optimal flow rates.
Results: The Respimat SMI had the slowest plume velocity (0.99 m/s) and longest spray duration (1447 ms) compared with pMDIs (velocity: 3.65-5.09 m/s; duration: 227-270 ms) and DPIs (velocity: 1.43-4.60 m/s; duration: 60-757 ms). With increasing flow rates, SMI aerosol duration was unaffected, but velocity increased (maximum 2.63 m/s), pMDI aerosol velocity and duration were unaffected, and DPI aerosol velocity tended to increase, with a more variable impact on duration.
Conclusions: Aerosol characteristics (velocity and duration of aerosol plume) vary by inhaler type. Plume velocity was lower and spray duration longer for the SMI compared with pMDIs and DPIs. Increasing experimental flow rate was associated with faster plume velocity for DPIs and the SMI, with no or variable impact on plume duration, whereas pMDI aerosol velocity and duration were unaffected by increasing flow rate.
{"title":"Aerosol Plumes of Inhalers Used in COPD.","authors":"Herbert Wachtel, Rachel Emerson-Stadler, Peter Langguth, Jens M Hohlfeld, Jill Ohar","doi":"10.1007/s41030-023-00249-5","DOIUrl":"10.1007/s41030-023-00249-5","url":null,"abstract":"<p><strong>Introduction: </strong>The selection of inhaler device is of critical importance in chronic obstructive pulmonary disease (COPD) as the interaction between a patient's inhalation profile and the aerosol characteristics of an inhaler can affect drug delivery and lung deposition. This study assessed the in vitro aerosol characteristics of inhaler devices approved for the treatment of COPD, including a soft mist inhaler (SMI), pressurized metered-dose inhalers (pMDIs), and dry powder inhalers (DPIs).</p><p><strong>Methods: </strong>High-speed video recording was used to visualize and measure aerosol velocity and spray duration for nine different inhalers (one SMI, three pMDIs, and five DPIs), each containing dual or triple fixed-dose combinations of long-acting muscarinic receptor antagonists and long-acting β<sub>2</sub>-agonists, with or without an inhaled corticosteroid. Measurements were taken in triplicate at experimental flow rates of 30, 60, and 90 l/min. Optimal flow rates were defined based on pharmacopoeial testing requirements: 30 l/min for pMDIs and SMIs, and the rate achieving a 4-kPa pressure drop against internal inhaler resistance for DPIs. Comparison of aerosol plumes was based on the experimental flow rates closest to the optimal flow rates.</p><p><strong>Results: </strong>The Respimat SMI had the slowest plume velocity (0.99 m/s) and longest spray duration (1447 ms) compared with pMDIs (velocity: 3.65-5.09 m/s; duration: 227-270 ms) and DPIs (velocity: 1.43-4.60 m/s; duration: 60-757 ms). With increasing flow rates, SMI aerosol duration was unaffected, but velocity increased (maximum 2.63 m/s), pMDI aerosol velocity and duration were unaffected, and DPI aerosol velocity tended to increase, with a more variable impact on duration.</p><p><strong>Conclusions: </strong>Aerosol characteristics (velocity and duration of aerosol plume) vary by inhaler type. Plume velocity was lower and spray duration longer for the SMI compared with pMDIs and DPIs. Increasing experimental flow rate was associated with faster plume velocity for DPIs and the SMI, with no or variable impact on plume duration, whereas pMDI aerosol velocity and duration were unaffected by increasing flow rate.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01Epub Date: 2024-01-03DOI: 10.1007/s41030-023-00246-8
Annette Kainu, Ville A Vartiainen, Witold Mazur, Hanna Hisinger-Mölkänen, Federico Lavorini, Christer Janson, Martin Andersson
Introduction: There is increasing pressure to use environmentally friendly dry powder inhalers (DPI) instead of pressurized metered-dose inhalers (pMDI). However, correct inhalation technique is needed for effective inhaler therapy, and there is persistent concern whether patients with chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory effort to use DPIs successfully. The aims of this study were to find clinical predictors for peak inspiratory flow rate (PIF) and to assess whether patients with COPD had difficulties in generating sufficient PIF with a high resistance DPI.
Methods: Pooled data of 246 patients with COPD from previous clinical trials was analyzed to find possible predictors of PIF via the DPI Easyhaler (PIFEH) and to assess the proportion of patients able to achieve an inhalation flow rate of 30 l/min, which is needed to use the Easyhaler successfully.
Results: The mean PIF was 56.9 l/min and 99% (243/246) of the study patients achieved a PIF ≥ 30 l/min. A low PIF was associated with female gender and lower forced expiratory volume in 1 s (FEV1), but the association was weak and a statistical model including both only accounted for 18% of the variation seen in PIFEH.
Conclusions: Based on our results, impaired expiratory lung function or patient characteristics do not predict patients' ability to use DPIs in COPD; 99% of the patients generated sufficient PIFEH for successful dose delivery. Considering the targets for sustainability in health care, this should be addressed as DPIs are a potential option for most patients when choosing the right inhaler for the patient.
Trial registration: Two of three included trials were registered under numbers NCT04147572 and NCT01424137. Third trial preceded registration platforms and therefore, was not registered.
{"title":"Successful Use of Easyhaler<sup>®</sup> Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials.","authors":"Annette Kainu, Ville A Vartiainen, Witold Mazur, Hanna Hisinger-Mölkänen, Federico Lavorini, Christer Janson, Martin Andersson","doi":"10.1007/s41030-023-00246-8","DOIUrl":"10.1007/s41030-023-00246-8","url":null,"abstract":"<p><strong>Introduction: </strong>There is increasing pressure to use environmentally friendly dry powder inhalers (DPI) instead of pressurized metered-dose inhalers (pMDI). However, correct inhalation technique is needed for effective inhaler therapy, and there is persistent concern whether patients with chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory effort to use DPIs successfully. The aims of this study were to find clinical predictors for peak inspiratory flow rate (PIF) and to assess whether patients with COPD had difficulties in generating sufficient PIF with a high resistance DPI.</p><p><strong>Methods: </strong>Pooled data of 246 patients with COPD from previous clinical trials was analyzed to find possible predictors of PIF via the DPI Easyhaler (PIFEH) and to assess the proportion of patients able to achieve an inhalation flow rate of 30 l/min, which is needed to use the Easyhaler successfully.</p><p><strong>Results: </strong>The mean PIF was 56.9 l/min and 99% (243/246) of the study patients achieved a PIF ≥ 30 l/min. A low PIF was associated with female gender and lower forced expiratory volume in 1 s (FEV1), but the association was weak and a statistical model including both only accounted for 18% of the variation seen in PIFEH.</p><p><strong>Conclusions: </strong>Based on our results, impaired expiratory lung function or patient characteristics do not predict patients' ability to use DPIs in COPD; 99% of the patients generated sufficient PIFEH for successful dose delivery. Considering the targets for sustainability in health care, this should be addressed as DPIs are a potential option for most patients when choosing the right inhaler for the patient.</p><p><strong>Trial registration: </strong>Two of three included trials were registered under numbers NCT04147572 and NCT01424137. Third trial preceded registration platforms and therefore, was not registered.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01Epub Date: 2023-12-19DOI: 10.1007/s41030-023-00248-6
Antonio Anzueto, Mark Cohen, Andres L Echazarreta, Gehan Elassal, Irma Godoy, Rafael Paramo, Abdullah Sayiner, Carlos A Torres-Duque, Sudeep Acharya, Bhumika Aggarwal, Hakan Erkus, Gur Levy
Introduction: The objective of this Delphi study was to understand and assess the level of consensus among respiratory experts on the clinical application of GOLD 2023 recommendations in management of patients with chronic obstructive pulmonary disease (COPD).
Methods: The study comprised two online surveys and a participant meeting with 34 respiratory experts from 16 countries. Responses of 73 questions were recorded using a Likert scale ranging from 0 (disagreement) to 9 (agreement). The consensus threshold was 75%.
Results: Survey 1 and survey 2 had 34 and 32 participants, respectively; and 25 attended the participant meeting. Consensus was reached on survey 1: 28/42; survey 2: 18/30 close-ended questions. A consensus was reached on the clinical relevance of most updates in definitions and diagnosis of COPD. Mixed results for the treatment recommendations by GOLD were noted: 74% agreed with the recommendation to initiate treatment with dual bronchodilators for group E patients; 63% agreed for including inhaled corticosteroids (ICS)/long-acting β2 agonist(LABA)/ Long-acting muscarinic receptor antagonists (LAMA) as a treatment option for GOLD B patients. Also, consensus lacked on removing ICS + LABA as an initial therapeutic option, in countries with challenges in access to other treatment option;. 88% agreed that they use GOLD recommendations in their daily clinical practice.
Conclusions: This Delphi study demonstrated a high level of consensus regarding key concepts of GOLD 2023 report, with most participants favoring recent updates in definitions, diagnosis, management, and prevention of COPD. More evidence on the etiotype based management and treatment options for group B and E are required which could further strengthen clinical application of the GOLD report.
简介:本德尔菲研究旨在了解和评估呼吸科专家对 GOLD 2023 建议在慢性阻塞性肺疾病(COPD)患者管理中的临床应用的共识程度:研究包括两项在线调查和一次与会者会议,共有来自 16 个国家的 34 位呼吸科专家参加。对 73 个问题的回答采用李克特量表进行记录,量表范围从 0(不同意)到 9(同意)。共识阈值为 75%:调查 1 和调查 2 分别有 34 人和 32 人参加;25 人出席了与会者会议。调查 1:28/42;调查 2:18/30 个封闭式问题达成了共识。对于慢性阻塞性肺病定义和诊断方面的大多数更新内容的临床相关性达成了共识。对于 GOLD 提出的治疗建议,结果不一:74%的人同意 E 组患者开始使用双支气管扩张剂治疗的建议;63%的人同意将吸入式皮质类固醇(ICS)/长效 β2受体激动剂(LABA)/长效毒蕈碱受体拮抗剂(LAMA)作为 GOLD B 组患者的治疗选择。此外,在难以获得其他治疗方案的国家,对于取消将 ICS + LABA 作为初始治疗方案缺乏共识。88%的人同意在日常临床实践中使用 GOLD 建议:这项德尔菲研究表明,人们对 GOLD 2023 报告的关键概念达成了高度共识,大多数参与者赞成最近在慢性阻塞性肺疾病的定义、诊断、管理和预防方面的更新。需要更多关于基于病因类型的管理和 B 组和 E 组治疗方案的证据,这将进一步加强 GOLD 报告的临床应用。
{"title":"Delphi Consensus on Clinical Applications of GOLD 2023 Recommendations in COPD Management: How Aligned are Recommendations with Clinical Practice?","authors":"Antonio Anzueto, Mark Cohen, Andres L Echazarreta, Gehan Elassal, Irma Godoy, Rafael Paramo, Abdullah Sayiner, Carlos A Torres-Duque, Sudeep Acharya, Bhumika Aggarwal, Hakan Erkus, Gur Levy","doi":"10.1007/s41030-023-00248-6","DOIUrl":"10.1007/s41030-023-00248-6","url":null,"abstract":"<p><strong>Introduction: </strong>The objective of this Delphi study was to understand and assess the level of consensus among respiratory experts on the clinical application of GOLD 2023 recommendations in management of patients with chronic obstructive pulmonary disease (COPD).</p><p><strong>Methods: </strong>The study comprised two online surveys and a participant meeting with 34 respiratory experts from 16 countries. Responses of 73 questions were recorded using a Likert scale ranging from 0 (disagreement) to 9 (agreement). The consensus threshold was 75%.</p><p><strong>Results: </strong>Survey 1 and survey 2 had 34 and 32 participants, respectively; and 25 attended the participant meeting. Consensus was reached on survey 1: 28/42; survey 2: 18/30 close-ended questions. A consensus was reached on the clinical relevance of most updates in definitions and diagnosis of COPD. Mixed results for the treatment recommendations by GOLD were noted: 74% agreed with the recommendation to initiate treatment with dual bronchodilators for group E patients; 63% agreed for including inhaled corticosteroids (ICS)/long-acting β<sub>2</sub> agonist(LABA)/ Long-acting muscarinic receptor antagonists (LAMA) as a treatment option for GOLD B patients. Also, consensus lacked on removing ICS + LABA as an initial therapeutic option, in countries with challenges in access to other treatment option;. 88% agreed that they use GOLD recommendations in their daily clinical practice.</p><p><strong>Conclusions: </strong>This Delphi study demonstrated a high level of consensus regarding key concepts of GOLD 2023 report, with most participants favoring recent updates in definitions, diagnosis, management, and prevention of COPD. More evidence on the etiotype based management and treatment options for group B and E are required which could further strengthen clinical application of the GOLD report.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138807727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-08DOI: 10.1007/s41030-023-00245-9
Jeremy Cole, Iwona Cąpała-Szczurko, Stephanie Roseti, Claudia Chen, Scott Caveney, Anastasia A. Aksyuk, Katie Streicher, S. Ponnarambil, Gene Colice
{"title":"Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study","authors":"Jeremy Cole, Iwona Cąpała-Szczurko, Stephanie Roseti, Claudia Chen, Scott Caveney, Anastasia A. Aksyuk, Katie Streicher, S. Ponnarambil, Gene Colice","doi":"10.1007/s41030-023-00245-9","DOIUrl":"https://doi.org/10.1007/s41030-023-00245-9","url":null,"abstract":"","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138586919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2023-11-02DOI: 10.1007/s41030-023-00242-y
Luis Morales-Quinteros, Raffaele Scala, João Manoel Silva, Antonio Leidi, Alexandre Leszek, Rodrigo Vazquez-Guillamet, Sergi Pascual, Ary Serpa-Neto, Antonio Artigas, Marcus J Schultz
Introduction: Awake prone positioning has the potential to improve oxygenation and decrease respiratory rate, potentially reducing the need for intubation in patients with acute hypoxemic respiratory failure. We investigated awake prone positioning-induced changes in oxygenation and respiratory rate, and the prognostic capacity for intubation in patients with COVID-19 pneumonia.
Methods: International multicenter prospective observation study in critically ill adult patients with COVID-19 receiving supplemental oxygen. We collected data on oxygenation and respiratory rate at baseline, and at 1 h after being placed in prone positioning. The combined primary outcome was oxygenation and respiratory rate at 1 h. The secondary endpoint was treatment failure, defined as need for intubation within 24 h of start of awake prone positioning.
Results: Between March 27th and November 2020, 101 patients were enrolled of which 99 were fully analyzable. Awake prone positioning lasted mean of 3 [2-4] h. In 77 patients (77.7%), awake prone positioning improved oxygenation, and in 37 patients (54.4%) it decreased respiratory rate. Twenty-nine patients (29.3%) were intubated within 24 h. An increase in SpO2/FiO2 of < 10 (OR 5.1, 95% CI 1.4-18.5, P = 0.01), a failure to increase PaO2/FiO2 to > 116 mmHg (OR 3.6, 95% CI 1.2-10.8, P = 0.02), and a decrease in respiratory rate of < 2 breaths/min (OR 3.6, 95% CI 1.3-9.5, P = 0.01) were independent variables associated with need for intubation. The AUC-ROC curve for intubation using a multivariable model was 0.73 (95% CI 0.62-0.84).
Conclusions: Awake prone positioning improves oxygenation in the majority of patients, and decreases respiratory rate in more than half of patients with acute hypoxemic respiratory failure caused by COVID-19. One in three patients need intubation within 24 h. Awake prone position-induced changes in oxygenation and respiratory rate have prognostic capacity for intubation within 24 h.
{"title":"Associations of Awake Prone Positioning-Induced Changes in Physiology with Intubation: An International Prospective Observational Study in Patients with Acute Hypoxemic Respiratory Failure Related to COVID-19.","authors":"Luis Morales-Quinteros, Raffaele Scala, João Manoel Silva, Antonio Leidi, Alexandre Leszek, Rodrigo Vazquez-Guillamet, Sergi Pascual, Ary Serpa-Neto, Antonio Artigas, Marcus J Schultz","doi":"10.1007/s41030-023-00242-y","DOIUrl":"10.1007/s41030-023-00242-y","url":null,"abstract":"<p><strong>Introduction: </strong>Awake prone positioning has the potential to improve oxygenation and decrease respiratory rate, potentially reducing the need for intubation in patients with acute hypoxemic respiratory failure. We investigated awake prone positioning-induced changes in oxygenation and respiratory rate, and the prognostic capacity for intubation in patients with COVID-19 pneumonia.</p><p><strong>Methods: </strong>International multicenter prospective observation study in critically ill adult patients with COVID-19 receiving supplemental oxygen. We collected data on oxygenation and respiratory rate at baseline, and at 1 h after being placed in prone positioning. The combined primary outcome was oxygenation and respiratory rate at 1 h. The secondary endpoint was treatment failure, defined as need for intubation within 24 h of start of awake prone positioning.</p><p><strong>Results: </strong>Between March 27th and November 2020, 101 patients were enrolled of which 99 were fully analyzable. Awake prone positioning lasted mean of 3 [2-4] h. In 77 patients (77.7%), awake prone positioning improved oxygenation, and in 37 patients (54.4%) it decreased respiratory rate. Twenty-nine patients (29.3%) were intubated within 24 h. An increase in SpO<sub>2</sub>/FiO<sub>2</sub> of < 10 (OR 5.1, 95% CI 1.4-18.5, P = 0.01), a failure to increase PaO<sub>2</sub>/FiO<sub>2</sub> to > 116 mmHg (OR 3.6, 95% CI 1.2-10.8, P = 0.02), and a decrease in respiratory rate of < 2 breaths/min (OR 3.6, 95% CI 1.3-9.5, P = 0.01) were independent variables associated with need for intubation. The AUC-ROC curve for intubation using a multivariable model was 0.73 (95% CI 0.62-0.84).</p><p><strong>Conclusions: </strong>Awake prone positioning improves oxygenation in the majority of patients, and decreases respiratory rate in more than half of patients with acute hypoxemic respiratory failure caused by COVID-19. One in three patients need intubation within 24 h. Awake prone position-induced changes in oxygenation and respiratory rate have prognostic capacity for intubation within 24 h.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10721579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71426356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2023-11-22DOI: 10.1007/s41030-023-00244-w
Junichi Omura, Yogeshwar Makanji, Nobuhiro Tanabe, Dae Young Yu, Jin Yu Tan, Sooyeol Lim, Mahsa H Kouhkamari, Jeremy Casorso, David Bin-Chia Wu, Paul Bloomfield
Introduction: Real-world data on the comparative effectiveness of endothelin receptor antagonists (ERAs; macitentan, bosentan, ambrisentan) for pulmonary arterial hypertension (PAH), particularly in Asian countries, are scarce. We evaluated the persistence of these ERAs before and after macitentan approval in Japan (2015).
Methods: We used real-world data from the Japanese Medical Data Vision administrative claims database between April 2008 and November 2020. Patients with PAH were identified from the dataset. Persistence to ERA treatment before and after approval of macitentan in Japan was defined as the time between start of the index ERA and treatment discontinuation or death. Propensity score adjustment was applied to minimize confounding effects among treatment groups.
Results: In the pre-macitentan approval cohort, 153 and 51 patients received bosentan and ambrisentan, respectively. In the post-macitentan approval cohort, 331, 284, and 91 patients received macitentan, bosentan, and ambrisentan, respectively. Unadjusted median persistence for ambrisentan- and bosentan-treated patients was 19 and 10 months, respectively (adjusted HR 0.87 [95% CI 0.61-1.24]; P = 0.434 [bosentan as reference]). In the post-macitentan approval cohort, unadjusted median persistence was 18 months for macitentan-treated patients versus 6 and 8 months for ambrisentan- and bosentan-treated patients, respectively. Adjusted HRs for ambrisentan and bosentan were 1.48 (95% CI 1.12-1.95; P = 0.006) and 1.63 (95% CI 1.30-2.04; P < 0.001 [macitentan as reference]), respectively.
Conclusions: Real-world data for Japanese patients with PAH showed that persistence was significantly higher for macitentan, versus ambrisentan and bosentan, since its approval.
引言:内皮素受体拮抗剂(ERAs;特别是在亚洲国家,用于肺动脉高压(PAH)的马伐他坦,波生坦,安布里森坦(ambristan)非常稀缺。我们在日本(2015年)批准马西坦前后评估了这些era的持久性。方法:我们使用2008年4月至2020年11月日本医疗数据视觉管理索赔数据库中的真实数据。从数据集中确定了多环芳烃患者。在日本,马西坦获批前后对ERA治疗的持续时间定义为开始指标ERA到停止治疗或死亡之间的时间。倾向评分调整用于减少治疗组间的混杂效应。结果:在马西坦批准前队列中,分别有153名和51名患者接受了波生坦和安布里森坦。在马张坦批准后的队列中,分别有331,284和91名患者接受了马张坦,波生坦和安布里森坦。安布里森坦和波生坦治疗的患者未调整的中位持续时间分别为19个月和10个月(调整后HR 0.87 [95% CI 0.61-1.24];P = 0.434[波生坦为参考])。在马西坦批准后的队列中,马西坦治疗的患者未调整的中位持续时间为18个月,而安布里森坦和波生坦治疗的患者分别为6个月和8个月。安布里森坦和波生坦的调整后hr为1.48 (95% CI 1.12-1.95;P = 0.006)和1.63 (95% CI 1.30-2.04;结论:日本PAH患者的真实数据显示,自批准以来,与ambrisentan和bosentan相比,macitentan的持久性明显更高。
{"title":"Comparative Treatment Persistence and Adherence to Endothelin Receptor Antagonists Among Patients with Pulmonary Arterial Hypertension in Japan: A Real-World Administrative Claims Database Study.","authors":"Junichi Omura, Yogeshwar Makanji, Nobuhiro Tanabe, Dae Young Yu, Jin Yu Tan, Sooyeol Lim, Mahsa H Kouhkamari, Jeremy Casorso, David Bin-Chia Wu, Paul Bloomfield","doi":"10.1007/s41030-023-00244-w","DOIUrl":"10.1007/s41030-023-00244-w","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world data on the comparative effectiveness of endothelin receptor antagonists (ERAs; macitentan, bosentan, ambrisentan) for pulmonary arterial hypertension (PAH), particularly in Asian countries, are scarce. We evaluated the persistence of these ERAs before and after macitentan approval in Japan (2015).</p><p><strong>Methods: </strong>We used real-world data from the Japanese Medical Data Vision administrative claims database between April 2008 and November 2020. Patients with PAH were identified from the dataset. Persistence to ERA treatment before and after approval of macitentan in Japan was defined as the time between start of the index ERA and treatment discontinuation or death. Propensity score adjustment was applied to minimize confounding effects among treatment groups.</p><p><strong>Results: </strong>In the pre-macitentan approval cohort, 153 and 51 patients received bosentan and ambrisentan, respectively. In the post-macitentan approval cohort, 331, 284, and 91 patients received macitentan, bosentan, and ambrisentan, respectively. Unadjusted median persistence for ambrisentan- and bosentan-treated patients was 19 and 10 months, respectively (adjusted HR 0.87 [95% CI 0.61-1.24]; P = 0.434 [bosentan as reference]). In the post-macitentan approval cohort, unadjusted median persistence was 18 months for macitentan-treated patients versus 6 and 8 months for ambrisentan- and bosentan-treated patients, respectively. Adjusted HRs for ambrisentan and bosentan were 1.48 (95% CI 1.12-1.95; P = 0.006) and 1.63 (95% CI 1.30-2.04; P < 0.001 [macitentan as reference]), respectively.</p><p><strong>Conclusions: </strong>Real-world data for Japanese patients with PAH showed that persistence was significantly higher for macitentan, versus ambrisentan and bosentan, since its approval.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10721767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138291698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2023-10-10DOI: 10.1007/s41030-023-00240-0
Efrat Eliyahu, Michael G Katz, Adam Vincek, Lina Freage-Kahn, Shana Ravvin, Smadar Tal, Henry Grage, Nataly Shtraizent, Tuvia Barak, Bezalel Arkush
This review provides an overview of menopausal hormone therapy and pulmonary disease risk, with a focus on the effect of hormone replacement therapy (HRT) on pulmonary function and its relation to lung diseases. This summary is based on authors' knowledge in the field of HRT and supplemented by a PubMed search using the terms "menopause hormone therapy," "asthma", "lung cancer", "chronic obstructive pulmonary disease", "lung function", and "pulmonary hypertension". Available evidence indicates that there is limited research on the role of sex hormones in the susceptibility, severity, and progression of chronic respiratory diseases. However, some studies suggest that the hormonal changes that occur during the menopausal transition may have an impact on pulmonary function and respiratory diseases. Women are in need of convenient access to a safe and effective modality for personalized HRT based on an artificial intelligence (AI)-driven platform that will enable them to receive personalized hormonal treatment through frequent, convenient, and accurate measurements of hormone levels in peripheral blood.
{"title":"Effects of Hormone Replacement Therapy on Women's Lung Health and Disease.","authors":"Efrat Eliyahu, Michael G Katz, Adam Vincek, Lina Freage-Kahn, Shana Ravvin, Smadar Tal, Henry Grage, Nataly Shtraizent, Tuvia Barak, Bezalel Arkush","doi":"10.1007/s41030-023-00240-0","DOIUrl":"10.1007/s41030-023-00240-0","url":null,"abstract":"<p><p>This review provides an overview of menopausal hormone therapy and pulmonary disease risk, with a focus on the effect of hormone replacement therapy (HRT) on pulmonary function and its relation to lung diseases. This summary is based on authors' knowledge in the field of HRT and supplemented by a PubMed search using the terms \"menopause hormone therapy,\" \"asthma\", \"lung cancer\", \"chronic obstructive pulmonary disease\", \"lung function\", and \"pulmonary hypertension\". Available evidence indicates that there is limited research on the role of sex hormones in the susceptibility, severity, and progression of chronic respiratory diseases. However, some studies suggest that the hormonal changes that occur during the menopausal transition may have an impact on pulmonary function and respiratory diseases. Women are in need of convenient access to a safe and effective modality for personalized HRT based on an artificial intelligence (AI)-driven platform that will enable them to receive personalized hormonal treatment through frequent, convenient, and accurate measurements of hormone levels in peripheral blood.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10721592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41183400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2023-09-25DOI: 10.1007/s41030-023-00239-7
Matleena Inget, Hanna Hisinger-Mölkänen, Myles Howard, Satu Lähelmä, Noora Paronen
Introduction: There is increasing pressure to prefer propellant-free inhaler devices over pressurized metered-dose inhalers (pMDI) due to environmental considerations. In this work, we present results from three life cycle assessments (LCAs) on Easyhaler dry powder inhaler product portfolio and assess the changes in environmental impact and carbon footprint (CF) of the products over time.
Methods: Three cradle-to-grave LCAs were conducted in 2019, 2021, and 2023. The 2019 assessment covered four products while 2021 and 2023 assessments included all six products in the portfolio. LCA for the protective cover sometimes used with Easyhaler was conducted in 2023. In addition to CF, nine other environmental impact categories were assessed to ensure that no burden shifting occurs.
Results: During the study period, the non-weighted average CF of the Easyhaler decreased by 11.2%. For individual products, the decrease varied from 5.0 to 6.8% between the assessments. In the latest assessment, the average CF of Easyhaler was 547 gCO2e with a range of 452-617 gCO2e. The LCA of the protective cover was assessed for the first time in 2023 and had a CF of 66 gCO2e.
Conclusions: Our results show that the climate impact of pharmaceutical products can be reduced without making changes to the product itself. The CF of Easyhaler products is in agreement with the lower end of the CF range previously reported for dry powder inhalers. Climate impact from the protective cover was one-tenth compared to the climate impact from the product itself.
{"title":"Cradle-to-Grave Emission Reduction for Easyhaler Dry Powder Inhaler Product Portfolio.","authors":"Matleena Inget, Hanna Hisinger-Mölkänen, Myles Howard, Satu Lähelmä, Noora Paronen","doi":"10.1007/s41030-023-00239-7","DOIUrl":"10.1007/s41030-023-00239-7","url":null,"abstract":"<p><strong>Introduction: </strong>There is increasing pressure to prefer propellant-free inhaler devices over pressurized metered-dose inhalers (pMDI) due to environmental considerations. In this work, we present results from three life cycle assessments (LCAs) on Easyhaler dry powder inhaler product portfolio and assess the changes in environmental impact and carbon footprint (CF) of the products over time.</p><p><strong>Methods: </strong>Three cradle-to-grave LCAs were conducted in 2019, 2021, and 2023. The 2019 assessment covered four products while 2021 and 2023 assessments included all six products in the portfolio. LCA for the protective cover sometimes used with Easyhaler was conducted in 2023. In addition to CF, nine other environmental impact categories were assessed to ensure that no burden shifting occurs.</p><p><strong>Results: </strong>During the study period, the non-weighted average CF of the Easyhaler decreased by 11.2%. For individual products, the decrease varied from 5.0 to 6.8% between the assessments. In the latest assessment, the average CF of Easyhaler was 547 gCO<sub>2</sub>e with a range of 452-617 gCO<sub>2</sub>e. The LCA of the protective cover was assessed for the first time in 2023 and had a CF of 66 gCO<sub>2</sub>e.</p><p><strong>Conclusions: </strong>Our results show that the climate impact of pharmaceutical products can be reduced without making changes to the product itself. The CF of Easyhaler products is in agreement with the lower end of the CF range previously reported for dry powder inhalers. Climate impact from the protective cover was one-tenth compared to the climate impact from the product itself.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10721773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41150477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}