Safety of inhaled glycopyrronium in patients with COPD: A comprehensive analysis of clinical studies and post-marketing data

International Journal of COPD

Volumn 10, Issue 1, 2015, Pages 1599-1612

  D’Urzo, Anthony D ^a   Kerwin, Edward M ^b   Chapman, Kenneth R ^c   Decramer, Marc ^d   DiGiovanni, Robert ^e   D’Andrea, Peter ^e   Hu, Huilin ^e   Goyal, Pankaj ^e   Altman, Pablo ^e  

^a UNIVERSITY OF TORONTO   (Canada)

^b Clinical Research Institute of Southern Oregon PC   (United States)

^c TORONTO WESTERN HOSPITAL   (Canada)

^d UNIVERSITY OF LEUVEN   (Belgium)

^e NOVARTIS PHARMA AG   (Switzerland)

Author keywords

COPD; Drug safety; Glycopyrronium; Post marketing surveillance

Indexed keywords

CORTICOSTEROID; GLYCOPYRRONIUM BROMIDE; PLACEBO; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT; GLYCOPYRRONIUM; MUSCARINIC RECEPTOR BLOCKING AGENT;

ABDOMINAL PAIN; ACUTE CORONARY SYNDROME; ACUTE RESPIRATORY FAILURE; AGED; ANGINA PECTORIS; ARTICLE; ATRIAL FIBRILLATION; BLURRED VISION; BRAIN HEMORRHAGE; BRONCHITIS; CARDIOPULMONARY INSUFFICIENCY; CATARACT; CELLULITIS; CEREBROVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DRUG FATALITY; DRUG SAFETY; DRY EYE; DRY POWDER INHALER; DYSGEUSIA; DYSPEPSIA; DYSPHONIA; DYSPNEA; DYSURIA; EPISTAXIS; FAINTNESS; FEMALE; FEVER; GASTROENTERITIS; GASTROESOPHAGEAL REFLUX; HEADACHE; HEART ARRHYTHMIA; HEART FAILURE; HEART INFARCTION; HEART PALPITATION; HUMAN; INFLUENZA; INHALER; INSOMNIA; ISCHEMIC HEART DISEASE; LIMB PAIN; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NOSE OBSTRUCTION; OROPHARYNX PAIN; PHARYNGITIS; PNEUMONIA; PNEUMOTHORAX; POLLAKISURIA; POSTMARKETING SURVEILLANCE; PRURITUS; RASH; RESPIRATORY FAILURE; RHINITIS; RHINOPHARYNGITIS; RHINORRHEA; RISK ASSESSMENT; SINUS CONGESTION; SINUSITIS; TACHYCARDIA; THROAT IRRITATION; THRUSH; TOOTH PAIN; TRANSIENT ISCHEMIC ATTACK; UNSPECIFIED SIDE EFFECT; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URINE RETENTION; VIRAL GASTROENTERITIS; VIRAL RESPIRATORY TRACT INFECTION; VIRAL UPPER RESPIRATORY TRACT INFECTION; VISUAL IMPAIRMENT; VOMITING; XEROSTOMIA; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; LUNG; MIDDLE AGED; MORTALITY; NEBULIZER; PATHOPHYSIOLOGY; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME; VERY ELDERLY;

ADMINISTRATION, INHALATION; AGED; AGED, 80 AND OVER; BRONCHODILATOR AGENTS; FEMALE; GLYCOPYRROLATE; HUMANS; LUNG; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; NEBULIZERS AND VAPORIZERS; PATIENT SAFETY; PRODUCT SURVEILLANCE, POSTMARKETING; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84939233935     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S81266     Document Type: Article

References (20)

1. Global Strategy for the Diagnosis, Management and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD); 2015. Available from: http://www.goldcopd.org/. Accessed April 22, 2015.
2. Sharafkhaneh A, Majid H, Gross NJ. Safety and tolerability of inha­lational anticholinergics in COPD. Drug Healthc Patient Saf. 2013;5:49–55.
3. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ. 2011;2011(342):d3215.
4. Wise RA, Anzueto A, Cotton D, et al; IOSPIR Investigators. Tiotropium respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491–1501.
5. Jenkins CR. More than just reassurance on tiotropium safety. N Engl J Med. 2013;369(16):1555–1556.
6. Jenkins CR. Tiotropium and the risk of death in COPD. N Engl J Med. 2014;370(5):482–483.
7. Loke YK, Singh S, Furberg CD. Tiotropium and the risk of death in COPD. N Engl J Med. 2014;30(5):480–481.
8. Verhamme KM, van Blijderveen N, Sturkenboom MC. Tiotropium and the risk of death in COPD. N Engl J Med. 2014;370(5):481–482.
9. Wise RA. Tiotropium and the risk of death in COPD. N Engl J Med. 2014;370(5):482.
10. Fogarty C, Hattersley H, Di SL, Drollmann A. Bronchodilatory effects of NVA237, a once daily long-acting muscarinic antagonist, in COPD patients. Respir Med. 2011;105(3):337–342.
11. D’Urzo AD, Kerwin E, Overend T, D’Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014;30(3):493–508.
12. Sykes DA, Dowling MR, Leighton-Davies J, et al. The Influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropium. J Pharmacol Exp Ther. 2012;343(2):520–528.
13. D’Urzo AD, Ferguson GT, van Noord JA, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011;2011(12):156.
14. Kerwin E, Hébert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012;40(5):1106–1114.
15. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42(6):1484–1494.
16. Chapman KR, Beeh KM, Beier J, et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting musca­rinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014;2014(14):4.
17. Chen W, Tieying S, Yijiang H, et al. Efficacy and safety of once-daily glycopyrronium in predominantly Chinese patients with moderate-to-severe chronic obstructive pulmonary disease (COPD): the GLOW7 study. B104. It’s No Longer a Secret Service: Updates in COPD Pharmacotherapy. American Thoracic Society, San Diego, USA 2014: A3756–A3756.
18. Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotro­pium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209.
19. Szarfman A, Machado SG, O’Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected com­binations of drugs and events in the US FDA’s spontaneous reports database. Drug Saf. 2002;25(6):381–392.
20. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2008;300(12):1439–1450.