Impact of Comorbidity Prevalence and Cardiovascular Disease Status on the Efficacy and Safety of Nebulized Glycopyrrolate in Patients with COPD

References

• Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management and prevention of COPD; 2020. Available from: http://goldcopd.org/. Accessed July 28, 2020.
   Google Scholar
• Raherison C, Ouaalaya EH, Bernady A, et al. Comorbidities and COPD severity in a clinic-based cohort. BMC Pulm Med. 2018;18(1):117. doi:10.1186/s12890-018-0684-7
   PubMedGoogle Scholar
• Brown JP, Martinez CH. Chronic obstructive pulmonary disease comorbidities. Curr Opin Pulm Med. 2016;22(2):113–118. doi:10.1097/MCP.0000000000000241
   PubMed Web of Science ®Google Scholar
• Divo M, Cote C, de Torres JP, et al. Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012;186(2):155–161. doi:10.1164/rccm.201201-0034OC
   PubMed Web of Science ®Google Scholar
• Holguin F, Folch E, Redd SC, Mannino DM. Comorbidity and mortality in COPD-related hospitalizations in the United States, 1979 to 2001. Chest. 2005;128(4):2005–2011. doi:10.1378/chest.128.4.2005
   PubMed Web of Science ®Google Scholar
• Morgan AD, Zakeri R, Quint JK. Defining the relationship between COPD and CVD: what are the implications for clinical practice? Ther Adv Respir Dis. 2018;12:1753465817750524. doi:10.1177/1753465817750524
   Web of Science ®Google Scholar
• Rabe KF, Hurst JR, Suissa S. Cardiovascular disease and COPD: dangerous liaisons? Eur Respir Rev. 2018;27(149):180057. doi:10.1183/16000617.0057-2018
   PubMed Web of Science ®Google Scholar
• Mannino DM, Thorn D, Swensen A, Holguin F. Prevalence and outcomes of diabetes, hypertension and cardiovascular disease in COPD. Eur Respir J. 2008;32(4):962–969. doi:10.1183/09031936.00012408
   PubMed Web of Science ®Google Scholar
• Chen W, Thomas J, Sadatsafavi M, FitzGerald JM. Risk of cardiovascular comorbidity in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Lancet Respir Med. 2015;3(8):631–639. doi:10.1016/S2213-2600(15)00241-6
   PubMed Web of Science ®Google Scholar
• Putcha N, Puhan MA, Drummond MB, et al. A simplified score to quantify comorbidity in COPD. PLoS One. 2014;9(12):e114438. doi:10.1371/journal.pone.0114438
   PubMed Web of Science ®Google Scholar
• Regan EA, Hokanson JE, Murphy JR, et al. Genetic epidemiology of COPD (COPDGene) study design. COPD. 2010;7(1):32–43. doi:10.3109/15412550903499522
   PubMedGoogle Scholar
• Couper D, LaVange LM, Han M, et al. Design of the subpopulations and intermediate outcomes in COPD Study (SPIROMICS). Thorax. 2014;69(5):491–494. doi:10.1136/thoraxjnl-2013-203897
   PubMed Web of Science ®Google Scholar
• Lahousse L, Verhamme KM, Stricker BH, Brusselle GG. Cardiac effects of current treatments of chronic obstructive pulmonary disease. Lancet Respir Med. 2016;4(2):149–164. doi:10.1016/S2213-2600(15)00518-4
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Amin AN, Kerwin EM. Comparing randomized controlled trials and real-world studies in chronic obstructive pulmonary disease pharmacotherapy. Int J Chron Obstruct Pulmon Dis. 2020;15:1225–1243. doi:10.2147/COPD.S244942
   PubMed Web of Science ®Google Scholar
• Pham S, Ferguson GT, Kerwin E, Goodin T, Wheeler A, Bauer A. In vitro characterization of the eFlow® closed system nebulizer with glycopyrrolate inhalation solution. J Aerosol Med Pulm Drug Deliv. 2018;31(3):162–169. doi:10.1089/jamp.2017.1384
   PubMed Web of Science ®Google Scholar
• Sunovion Pharmaceuticals Inc. Lonhala magnair (glycopyrrolate) inhalation solution: highlights of prescribing information; 2019.
   Google Scholar
• Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017;132:238–250. doi:10.1016/j.rmed.2017.07.011
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Goodin T, Tosiello R, Wheeler A, Kerwin E. Long-term safety of glycopyrrolate/eFlow® CS in moderate-to-very-severe COPD: results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study. Respir Med. 2017;132:251–260. doi:10.1016/j.rmed.2017.08.020
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Tosiello R, Sanjar S, Goodin T. 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. Chronic Obstr Pulm Dis. 2018;6(1):86–99. doi:10.15326/jcopdf.6.1.2018.0146
   PubMed Web of Science ®Google Scholar
• Carlin B, Ferguson GT, Ozol-Godfrey A, Goodin T, Sanjar S. The effect of metabolic syndrome status on lung function and patient-reported outcomes in patients with COPD receiving nebulized glycopyrrolate. Chronic Obstr Pulm Dis. 2020;7(4):315–326. doi:10.15326/jcopdf.7.4.2020.0145
   PubMed Web of Science ®Google Scholar
• Jones PW. St. George’s respiratory questionnaire: MCID. COPD. 2005;2(1):75–79. doi:10.1081/copd-200050513
   PubMedGoogle Scholar
• Vanfleteren LE, Spruit MA, Groenen M, et al. Clusters of comorbidities based on validated objective measurements and systemic inflammation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013;187(7):728–735. doi:10.1164/rccm.201209-1665OC
   PubMed Web of Science ®Google Scholar
• McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA. Ascertainment of cause-specific mortality in COPD: operations of the TORCH clinical endpoint committee. Thorax. 2007;62(5):411–415. doi:10.1136/thx.2006.072348
   PubMed Web of Science ®Google Scholar
• Berry CE, Wise RA. Mortality in COPD: causes, risk factors, and prevention. COPD. 2010;7(5):375–382. doi:10.3109/15412555.2010.510160
   PubMedGoogle Scholar
• Tiew PY, Ko FWS, Narayana JK, et al. “High-Risk” clinical and inflammatory clusters in COPD of Chinese descent. Chest. 2020;158(1):145–156. doi:10.1016/j.chest.2020.01.043
   PubMed Web of Science ®Google Scholar
• Vogel-Claussen J, Schonfeld CO, Kaireit TF, et al. Effect of indacaterol/glycopyrronium on pulmonary perfusion and ventilation in hyperinflated patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial. Am J Respir Crit Care Med. 2019;199(9):1086–1096. doi:10.1164/rccm.201805-0995OC
   PubMed Web of Science ®Google Scholar
• Hohlfeld JM, Vogel-Claussen J, Biller H, et al. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial. Lancet Respir Med. 2018;6(5):368–378. doi:10.1016/S2213-2600(18)30054-7
   PubMed Web of Science ®Google Scholar
• Stone IS, Barnes NC, James WY, et al. Lung deflation and cardiovascular structure and function in chronic obstructive pulmonary disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2016;193(7):717–726. doi:10.1164/rccm.201508-1647OC
   PubMed Web of Science ®Google Scholar
• O’Donnell DE, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23(6):832–840. doi:10.1183/09031936.04.00116004
   PubMed Web of Science ®Google Scholar
• Santus P, Centanni S, Verga M, Di Marco F, Matera MG, Cazzola M. Comparison of the acute effect of tiotropium versus a combination therapy with single inhaler budesonide/formoterol on the degree of resting pulmonary hyperinflation. Respir Med. 2006;100(7):1277–1281. doi:10.1016/j.rmed.2005.10.008
   PubMed Web of Science ®Google Scholar
• Santus P, Radovanovic D, Di Marco S, et al. Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trial. Int J Chron Obstruct Pulmon Dis. 2015;11(10):1917–1923. doi:10.2147/COPD.S91684
   Web of Science ®Google Scholar