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      Efficacy and Safety of Nebulized Glycopyrrolate/eFlow® Closed System in Patients with Moderate-to-Very-Severe Chronic Obstructive Pulmonary Disease with Pre-Existing Cardiovascular Risk Factors

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          Abstract

          Purpose: The purpose of this study was to assess the effect of pre-existing cardiovascular (CV) risk factors on the efficacy and safety of nebulized glycopyrrolate (GLY) in patients with chronic obstructive pulmonary disease (COPD).

          Methods: A total of 2379 patients from 3 phase III studies (12-week, placebo-controlled Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer [GOLDEN] -3 and -4, and 48-week, active-controlled GOLDEN-5) stratified by high (n=1526) or low (n=853) CV risk were randomized to placebo, GLY 25 mcg or 50 mcg twice daily, or tiotropium (TIO; 18 mcg once daily). Safety, lung function, patient-reported outcomes (PROs), and exacerbations were assessed by CV risk.

          Results: Treatment-emergent adverse events (TEAEs) were similar across CV risk subgroups, with serious TEAEs higher in the high CV risk subgroup. In the 12-week studies, discontinuation due to TEAEs with GLY 25 mcg and 50 mcg was similar between CV risk subgroups, and lower than placebo (high risk: 6.2%, 3.6%, 9.0%; low risk: 3.2%, 4.5%, 9.9%, respectively). In the 48-week, open-label study, discontinuation rates were higher with GLY versus TIO (high risk: 10.7%, 3.7%; low risk: 8.7%, 1.2%, respectively). Rates of CV events of special interest were similar across CV risk subgroups. Regardless of CV risk, GLY led to significant improvements in efficacy and PRO assessments at 12 weeks versus placebo, whereas changes were similar between GLY and TIO at 48 weeks, except for PROs in the low risk subgroup. Exacerbation rates were similar across all treatment groups.

          Conclusions: Nebulized GLY had an acceptable safety profile and improved lung function and PROs in COPD patients, irrespective of CV risk status.

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          Author and article information

          Journal
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
          COPD Foundation Inc (Miami, USA )
          2372-952X
          2019
          13 December 2018
          : 6
          : 1
          : 86-99
          Affiliations
          [1]Pulmonary Research Institute of Southeast Michigan, Farmington Hills
          [2]Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts
          Author notes
          Address correspondence to: Gary T. Ferguson, MD, Pulmonary Research Institute of Southeast Michigan 29255 West 10 Mile Road, Suite A Farmington Hills, MI 48336 Email: garytferguson@ 123456msn.com Phone: 248-478-6561

          Medical writing support was provided by Hashem Dbouk, PhD, of FireKite, an Ashfield company, part of UDG Healthcare plc and funded by Sunovion Pharmaceuticals Inc.

          Author Contributions: GTF and RT contributed to protocol development and design. GTF was involved in data acquisition; GTF, RT, SS, and TG were involved in data analysis and interpretation. GTF, RT, SS, and TG were involved at all stages of manuscript development, writing and revision.

          Data sharing statement: Sunovion Pharmaceuticals Inc. is part of a clinical trial data sharing consortium that facilitates access for qualified researchers to selected anonymized clinical trial data. For up-to-date information on data availability please visit https://www.clinicalstudydatarequest.com/Study-Sponsors.aspx and click on Sunovion.

          Gary T. Ferguson reports grants, personal fees, and non-financial support from Boehringer Ingelheim, AstraZeneca, and Sunovion Pharmaceuticals Inc., as well as grants and personal fees from Novartis, Pearl Therapeutics, and Theravance, grants from Forest, and personal fees from Meda, Verona, Mylan, Innoviva, and GlaxoSmithKline. Robert Tosiello, Shahin Sanjar, and Thomas Goodin are employees of Sunovion Pharmaceuticals Inc.

          Article
          PMC6373592 PMC6373592 6373592
          10.15326/jcopdf.6.1.2018.0146
          6373592
          30775427
          0620e8b7-72b6-4393-bcd5-d6ef37b0a2dd
          JCOPDF © 2019
          History
          : 30 September 2018
          Funding
          The GOLDEN studies were funded by Sunovion Pharmaceuticals Inc. Medical writing support was funded by Sunovion Pharmaceuticals Inc.
          Categories
          Original Research

          LAMA,copd,chronic obstructive pulmonary disease,glycopyrrolate,cardiovascular,eFlow,nebulized long-acting muscarinic antagonist

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