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Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD
Inhaled bronchodilators are central for the treatment of chronic obstructive pulmonary disease (COPD), as they can provide symptom relief and reduce the frequency and severity of exacerbations while improving health status and exercise tolerance. In 2017, glycopyrrolate (GLY) delivered via the eFlow...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Nature Publishing Group UK
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497491/ https://www.ncbi.nlm.nih.gov/pubmed/34620878 http://dx.doi.org/10.1038/s41533-021-00255-7 |
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author | Tashkin, Donald P. Niu, Xiaoli Sharma, Sanjay Sanjar, Shahin |
author_facet | Tashkin, Donald P. Niu, Xiaoli Sharma, Sanjay Sanjar, Shahin |
author_sort | Tashkin, Donald P. |
collection | PubMed |
description | Inhaled bronchodilators are central for the treatment of chronic obstructive pulmonary disease (COPD), as they can provide symptom relief and reduce the frequency and severity of exacerbations while improving health status and exercise tolerance. In 2017, glycopyrrolate (GLY) delivered via the eFlow® closed system (CS) nebulizer (nebulized GLY; 25 µg twice daily), was approved by the US Food and Drug Administration for maintenance treatment of moderate-to-very-severe COPD. This approval was based largely on results from the replicate, placebo-controlled, Phase III clinical trials- GOLDEN 3 and 4. In this review, we summarize key findings from secondary analyses of the GOLDEN 3 and 4 studies, and provide a comprehensive overview that may assist both pulmonologists and primary-care providers in their treatment decisions. Comorbidities are common among patients with COPD in clinical practice and may impact bronchodilator efficacy. This review highlights outcomes among subpopulations of patients with comorbidities (e.g., anxiety/depression, cardiovascular disease), and their impact on the efficacy of nebulized GLY. In addition, the efficacy and safety of nebulized GLY across various demographics (e.g., age, gender) and baseline disease characteristics (e.g., disease severity, rescue medication use) are discussed. Real-world outcomes with nebulized GLY, including device satisfaction, healthcare resource utilization, and exacerbations, are also presented. These secondary analyses and real-world data complement the primary results with nebulized GLY from Phase III studies and support the need for the inclusion of patients representative of real-world clinical practice in RCTs. In addition, these data suggest that RCTs for COPD therapies should be complemented with real-world observational studies. |
format | Online Article Text |
id | pubmed-8497491 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-84974912021-10-08 Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD Tashkin, Donald P. Niu, Xiaoli Sharma, Sanjay Sanjar, Shahin NPJ Prim Care Respir Med Review Article Inhaled bronchodilators are central for the treatment of chronic obstructive pulmonary disease (COPD), as they can provide symptom relief and reduce the frequency and severity of exacerbations while improving health status and exercise tolerance. In 2017, glycopyrrolate (GLY) delivered via the eFlow® closed system (CS) nebulizer (nebulized GLY; 25 µg twice daily), was approved by the US Food and Drug Administration for maintenance treatment of moderate-to-very-severe COPD. This approval was based largely on results from the replicate, placebo-controlled, Phase III clinical trials- GOLDEN 3 and 4. In this review, we summarize key findings from secondary analyses of the GOLDEN 3 and 4 studies, and provide a comprehensive overview that may assist both pulmonologists and primary-care providers in their treatment decisions. Comorbidities are common among patients with COPD in clinical practice and may impact bronchodilator efficacy. This review highlights outcomes among subpopulations of patients with comorbidities (e.g., anxiety/depression, cardiovascular disease), and their impact on the efficacy of nebulized GLY. In addition, the efficacy and safety of nebulized GLY across various demographics (e.g., age, gender) and baseline disease characteristics (e.g., disease severity, rescue medication use) are discussed. Real-world outcomes with nebulized GLY, including device satisfaction, healthcare resource utilization, and exacerbations, are also presented. These secondary analyses and real-world data complement the primary results with nebulized GLY from Phase III studies and support the need for the inclusion of patients representative of real-world clinical practice in RCTs. In addition, these data suggest that RCTs for COPD therapies should be complemented with real-world observational studies. Nature Publishing Group UK 2021-10-07 /pmc/articles/PMC8497491/ /pubmed/34620878 http://dx.doi.org/10.1038/s41533-021-00255-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Review Article Tashkin, Donald P. Niu, Xiaoli Sharma, Sanjay Sanjar, Shahin Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title | Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title_full | Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title_fullStr | Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title_full_unstemmed | Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title_short | Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD |
title_sort | impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in copd |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497491/ https://www.ncbi.nlm.nih.gov/pubmed/34620878 http://dx.doi.org/10.1038/s41533-021-00255-7 |
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