Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies

Jill A Ohar,1 Alyssa Bowling,2 Thomas Goodin,2 Barry Price,2 Ayca Ozol-Godfrey,2 Sanjay Sharma,2 Shahin Sanjar2 1Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Sunovion Pharmaceuticals Inc, Marlborough, MA, USA Purpose: Bronchodilator reversibility has be...

Full description

Bibliographic Details
Main Authors: Ohar JA, Bowling A, Goodin T, Price B, Ozol-Godfrey A, Sharma S, Sanjar S
Format: Article
Language:English
Published: Dove Medical Press 2019-02-01
Series:International Journal of COPD
Subjects:
Online Access:https://www.dovepress.com/efficacy-and-safety-of-glycopyrrolate-in-patients-with-copd-by-rever-peer-reviewed-article-COPD
_version_ 1819015840421380096
author Ohar JA
Bowling A
Goodin T
Price B
Ozol-Godfrey A
Sharma S
Sanjar S
author_facet Ohar JA
Bowling A
Goodin T
Price B
Ozol-Godfrey A
Sharma S
Sanjar S
author_sort Ohar JA
collection DOAJ
description Jill A Ohar,1 Alyssa Bowling,2 Thomas Goodin,2 Barry Price,2 Ayca Ozol-Godfrey,2 Sanjay Sharma,2 Shahin Sanjar2 1Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Sunovion Pharmaceuticals Inc, Marlborough, MA, USA Purpose: Bronchodilator reversibility has been reported in patients with COPD, although correlations between reversibility and treatment response are unclear. The effect of reversibility on lung function, health status, and dyspnea was assessed in patients with moderate-to-severe COPD receiving glycopyrrolate (GLY) 15.6 µg twice daily vs placebo in the Glycopyrrolate Effect on syMptoms and lung function 1 and 2 (GEM1 and GEM2) replicate, 12-week, placebo-controlled studies. Patients and methods: Reversibility was defined as a post-bronchodilator increase of ≥12% and ≥0.200 L in FEV1. FEV1 area under the curve from 0 to 12 hours (AUC0–12 h), trough FEV1, St George’s Respiratory Questionnaire (SGRQ) total score, COPD Assessment Test (CAT™) score, Transition Dyspnea Index (TDI) focal score, daily symptom scores, and rescue medication use were assessed by reversibility status. Incidences of adverse events and serious adverse events were also assessed. Results: Data from 846 patients enrolled in GEM1 and GEM2 with known reversibility status were pooled for post hoc analysis. GLY significantly improved FEV1 AUC0–12 h, trough FEV1, SGRQ and CAT total scores, and rescue medication use compared with placebo in reversible and nonreversible patients. Significant improvements in TDI focal score and daily symptom scores with GLY over placebo were observed only among reversible patients. Improvements in FEV1 AUC0-12 h (0.165 vs 0.078 L; P<0.001) and trough FEV1 (0.173 vs 0.070 L; P<0.001) were clinically relevant (based on minimal clinically important differences) and significantly greater in reversible compared with nonreversible patients receiving GLY. The safety profile of GLY was not affected by reversibility status. Conclusion: In this post hoc analysis, GLY was associated with significant improvements in lung function and patient-reported outcomes compared with placebo, mostly independent of reversibility status. In patients receiving GLY, improvements in lung function were greater in reversible compared with nonreversible patients. Reversibility status did not meaningfully impact the safety profile of GLY. Keywords: bronchodilator, COPD, glycopyrrolate, reversibility
first_indexed 2024-12-21T02:38:08Z
format Article
id doaj.art-37420eaf31d24de69b0cf0716e9fb8f0
institution Directory Open Access Journal
issn 1178-2005
language English
last_indexed 2024-12-21T02:38:08Z
publishDate 2019-02-01
publisher Dove Medical Press
record_format Article
series International Journal of COPD
spelling doaj.art-37420eaf31d24de69b0cf0716e9fb8f02022-12-21T19:18:44ZengDove Medical PressInternational Journal of COPD1178-20052019-02-01Volume 1446147044175Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studiesOhar JABowling AGoodin TPrice BOzol-Godfrey ASharma SSanjar SJill A Ohar,1 Alyssa Bowling,2 Thomas Goodin,2 Barry Price,2 Ayca Ozol-Godfrey,2 Sanjay Sharma,2 Shahin Sanjar2 1Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Sunovion Pharmaceuticals Inc, Marlborough, MA, USA Purpose: Bronchodilator reversibility has been reported in patients with COPD, although correlations between reversibility and treatment response are unclear. The effect of reversibility on lung function, health status, and dyspnea was assessed in patients with moderate-to-severe COPD receiving glycopyrrolate (GLY) 15.6 µg twice daily vs placebo in the Glycopyrrolate Effect on syMptoms and lung function 1 and 2 (GEM1 and GEM2) replicate, 12-week, placebo-controlled studies. Patients and methods: Reversibility was defined as a post-bronchodilator increase of ≥12% and ≥0.200 L in FEV1. FEV1 area under the curve from 0 to 12 hours (AUC0–12 h), trough FEV1, St George’s Respiratory Questionnaire (SGRQ) total score, COPD Assessment Test (CAT™) score, Transition Dyspnea Index (TDI) focal score, daily symptom scores, and rescue medication use were assessed by reversibility status. Incidences of adverse events and serious adverse events were also assessed. Results: Data from 846 patients enrolled in GEM1 and GEM2 with known reversibility status were pooled for post hoc analysis. GLY significantly improved FEV1 AUC0–12 h, trough FEV1, SGRQ and CAT total scores, and rescue medication use compared with placebo in reversible and nonreversible patients. Significant improvements in TDI focal score and daily symptom scores with GLY over placebo were observed only among reversible patients. Improvements in FEV1 AUC0-12 h (0.165 vs 0.078 L; P<0.001) and trough FEV1 (0.173 vs 0.070 L; P<0.001) were clinically relevant (based on minimal clinically important differences) and significantly greater in reversible compared with nonreversible patients receiving GLY. The safety profile of GLY was not affected by reversibility status. Conclusion: In this post hoc analysis, GLY was associated with significant improvements in lung function and patient-reported outcomes compared with placebo, mostly independent of reversibility status. In patients receiving GLY, improvements in lung function were greater in reversible compared with nonreversible patients. Reversibility status did not meaningfully impact the safety profile of GLY. Keywords: bronchodilator, COPD, glycopyrrolate, reversibilityhttps://www.dovepress.com/efficacy-and-safety-of-glycopyrrolate-in-patients-with-copd-by-rever-peer-reviewed-article-COPDbronchodilatorCOPDnebulized glycopyrrolatereversibility
spellingShingle Ohar JA
Bowling A
Goodin T
Price B
Ozol-Godfrey A
Sharma S
Sanjar S
Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
International Journal of COPD
bronchodilator
COPD
nebulized glycopyrrolate
reversibility
title Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
title_full Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
title_fullStr Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
title_full_unstemmed Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
title_short Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of the GEM1 and GEM2 12-week studies
title_sort efficacy and safety of glycopyrrolate in patients with copd by reversibility pooled analysis of the gem1 and gem2 12 week studies
topic bronchodilator
COPD
nebulized glycopyrrolate
reversibility
url https://www.dovepress.com/efficacy-and-safety-of-glycopyrrolate-in-patients-with-copd-by-rever-peer-reviewed-article-COPD
work_keys_str_mv AT oharja efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT bowlinga efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT goodint efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT priceb efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT ozolgodfreya efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT sharmas efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies
AT sanjars efficacyandsafetyofglycopyrrolateinpatientswithcopdbyreversibilitypooledanalysisofthegem1andgem212weekstudies