Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD

Abstract 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...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Donald P. Tashkin, Xiaoli Niu, Sanjay Sharma, Shahin Sanjar
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Diseases of the respiratory system RC705-779
Acceso en línea:	https://doaj.org/article/34def7afb7e54f30b071260caa02f52c
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:34def7afb7e54f30b071260caa02f52c
record_format	dspace
spelling	oai:doaj.org-article:34def7afb7e54f30b071260caa02f52c2021-12-02T17:13:14ZImpact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD10.1038/s41533-021-00255-72055-1010https://doaj.org/article/34def7afb7e54f30b071260caa02f52c2021-10-01T00:00:00Zhttps://doi.org/10.1038/s41533-021-00255-7https://doaj.org/toc/2055-1010Abstract 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.Donald P. TashkinXiaoli NiuSanjay SharmaShahin SanjarNature PortfolioarticleDiseases of the respiratory systemRC705-779ENnpj Primary Care Respiratory Medicine, Vol 31, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the respiratory system RC705-779
spellingShingle	Diseases of the respiratory system RC705-779 Donald P. Tashkin Xiaoli Niu Sanjay Sharma Shahin Sanjar Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD
description	Abstract 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	article
author	Donald P. Tashkin Xiaoli Niu Sanjay Sharma Shahin Sanjar
author_facet	Donald P. Tashkin Xiaoli Niu Sanjay Sharma Shahin Sanjar
author_sort	Donald P. Tashkin
title	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_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_sort	impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in copd
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/34def7afb7e54f30b071260caa02f52c
work_keys_str_mv	AT donaldptashkin impactofbaselineclinicalfeaturesonoutcomesofnebulizedglycopyrrolatetherapyincopd AT xiaoliniu impactofbaselineclinicalfeaturesonoutcomesofnebulizedglycopyrrolatetherapyincopd AT sanjaysharma impactofbaselineclinicalfeaturesonoutcomesofnebulizedglycopyrrolatetherapyincopd AT shahinsanjar impactofbaselineclinicalfeaturesonoutcomesofnebulizedglycopyrrolatetherapyincopd
_version_	1718381369846923264

Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD

Ejemplares similares