July 18, 2019
Virginia Schad, PharmD
https://www.pulmonologyadvisor.com/home/topics/copd/glycopyrrolate-improves-lung-function-in-chronic-obstructive-pulmonary-disease/
Glycopyrrolate inhalation powder may improve lung function significantly in patients with moderate to severe chronic obstructive pulmonary disease (COPD) regardless of baseline smoking status, according to a study published in Respiratory Research.1
COPD develops in approximately 50% of smokers,2 with 42% of all COPD-related deaths attributable to tobacco smoking.3 Approximately 40% of patients continue to smoke after COPD diagnosis,4 and treatment efficacy is often impaired in current smokers. Glycopyrrolate inhalation powder is a long-acting muscarinic antagonist that is approved by the United States Food and Drug Administration to be given at a dose of 15.6 µg twice daily for long-term maintenance treatment of airflow obstruction in patients with COPD.5
Researchers conducted a post-hoc analysis of pooled data from two 12-week studies (GEM1; ClinicalTrials.gov Identifier: NCT01709864 and GEM2; ClinicalTrials.gov Identifier: NCT01715298) in 867 patients (57% current smokers; 43% former smokers) to determine the effect of smoking status on the efficacy and safety of glycopyrrolate inhalation powder compared with placebo in patients with moderate to severe COPD.1
They found that glycopyrrolate inhalation powder significantly improved all lung function measures, St George’s Respiratory Questionnaire total score, and rescue medication use, independent of smoking status, and that the incidence of adverse events and serious adverse events was also similar regardless of smoking status. Current smokers receiving background inhaled corticosteroid therapy in addition to glycopyrrolate inhalation powder had nonsignificant improvements in trough forced expiratory volume in 1 second compared with placebo.
In addition, treatment with glycopyrrolate inhalation powder resulted in clinically important improvements in COPD assessment test scores, transition dyspnea index focal scores, and daily symptom scores in both current and former smokers, with significant improvements vs placebo only in current smokers.
“These data support the use of [glycopyrrolate inhalation powder] 15.6 μg [twice daily] in patients with moderate to severe COPD regardless of their baseline smoking status, although the magnitude of benefit may differ between current and ex-smokers,” the researchers wrote.1
References
Tashkin DP, Goodin T, Bowling A, et al. Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies. Respir Res. 2019;20(1):135.
Lundback B, Lindberg A, Lindstrom M, et al; for the Obstructive Lung Disease in Northern Sweden Studies. Not 15 but 50% of smokers develop COPD?—report from the Obstructive Lung Disease in Northern Sweden Studies. Respir Med. 2003;97(2):115-122.
World Health Organization. WHO Global Report: Mortality Attributable to Tobacco. Accessed July 12, 2019.
Jiménez-Ruiz CA, Andreas S, Lewis KE, et al. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015;46(1):61-79.
Sunovion Pharmaceuticals Inc. SEEBRI NEOHALER. Highlights of prescribing information. https://www.seebri.us/Seebri-Prescribing-Information.pdf. Revised January 2018. Accessed July
Virginia Schad, PharmD
https://www.pulmonologyadvisor.com/home/topics/copd/glycopyrrolate-improves-lung-function-in-chronic-obstructive-pulmonary-disease/
Glycopyrrolate inhalation powder may improve lung function significantly in patients with moderate to severe chronic obstructive pulmonary disease (COPD) regardless of baseline smoking status, according to a study published in Respiratory Research.1
COPD develops in approximately 50% of smokers,2 with 42% of all COPD-related deaths attributable to tobacco smoking.3 Approximately 40% of patients continue to smoke after COPD diagnosis,4 and treatment efficacy is often impaired in current smokers. Glycopyrrolate inhalation powder is a long-acting muscarinic antagonist that is approved by the United States Food and Drug Administration to be given at a dose of 15.6 µg twice daily for long-term maintenance treatment of airflow obstruction in patients with COPD.5
Researchers conducted a post-hoc analysis of pooled data from two 12-week studies (GEM1; ClinicalTrials.gov Identifier: NCT01709864 and GEM2; ClinicalTrials.gov Identifier: NCT01715298) in 867 patients (57% current smokers; 43% former smokers) to determine the effect of smoking status on the efficacy and safety of glycopyrrolate inhalation powder compared with placebo in patients with moderate to severe COPD.1
They found that glycopyrrolate inhalation powder significantly improved all lung function measures, St George’s Respiratory Questionnaire total score, and rescue medication use, independent of smoking status, and that the incidence of adverse events and serious adverse events was also similar regardless of smoking status. Current smokers receiving background inhaled corticosteroid therapy in addition to glycopyrrolate inhalation powder had nonsignificant improvements in trough forced expiratory volume in 1 second compared with placebo.
In addition, treatment with glycopyrrolate inhalation powder resulted in clinically important improvements in COPD assessment test scores, transition dyspnea index focal scores, and daily symptom scores in both current and former smokers, with significant improvements vs placebo only in current smokers.
“These data support the use of [glycopyrrolate inhalation powder] 15.6 μg [twice daily] in patients with moderate to severe COPD regardless of their baseline smoking status, although the magnitude of benefit may differ between current and ex-smokers,” the researchers wrote.1
References
Tashkin DP, Goodin T, Bowling A, et al. Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies. Respir Res. 2019;20(1):135.
Lundback B, Lindberg A, Lindstrom M, et al; for the Obstructive Lung Disease in Northern Sweden Studies. Not 15 but 50% of smokers develop COPD?—report from the Obstructive Lung Disease in Northern Sweden Studies. Respir Med. 2003;97(2):115-122.
World Health Organization. WHO Global Report: Mortality Attributable to Tobacco. Accessed July 12, 2019.
Jiménez-Ruiz CA, Andreas S, Lewis KE, et al. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015;46(1):61-79.
Sunovion Pharmaceuticals Inc. SEEBRI NEOHALER. Highlights of prescribing information. https://www.seebri.us/Seebri-Prescribing-Information.pdf. Revised January 2018. Accessed July