Umeclidinium for treating COPD: An evaluation of pharmacologic properties, safety and clinical use

Expert Opinion on Drug Safety

Volumn 13, Issue 11, 2014, Pages 1555-1561

  Manickam, Rajapriya ^a   Asija, Amit ^a   Aronow, Wilbert S ^a  

^a NEW YORK MEDICAL COLLEGE   (United States)

Author keywords

Bronchodilators; COPD; LAMA; Umeclidinium

Indexed keywords

MUSCARINIC RECEPTOR BLOCKING AGENT; QUINUCLIDINE DERIVATIVE; UMECLIDINIUM;

ANIMAL; DRUG ADMINISTRATION; DRUG EFFECTS; HUMAN; INHALATIONAL DRUG ADMINISTRATION; LUNG; PATHOPHYSIOLOGY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK ASSESSMENT; RISK FACTOR; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ANIMALS; DRUG ADMINISTRATION SCHEDULE; HUMANS; LUNG; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINUCLIDINES; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME;

EID: 84931826415     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2014.968550     Document Type: Article

References (29)

1. Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006;27:397-412
2. Celli B, Decramer M, Leimer I, et al. Cardiovascular safety of tiotropium in patients with COPD. CHEST J 2010;137(1):20-30
3. Moulton BC, Fryer AD. Muscarinic receptor antagonists, from folklore to pharmacology; finding drugs that actually work in asthma and COPD. Br J Pharmacol 2011;163:44e52
4. Salmon M, Luttmann MA, Foley JJ, et al. Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases. J Pharmacol Exp Ther 2013;345:260-70.
5. Detailed study characterizing the pharmacological activity.
6. Cahn A, Tal-Singer R, Pouliquen IJ, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies. Clin Drug Investig 2013;33:477-88
7. Lainé DI, Luttmann MA, Foley JJ, et al. The pre-clinical pharmacology of the inhaled muscarinic antagonist GSK573719 predicts once-daily clinical dosing. Eur Respir J 2011;38(Suppl 5): 613s
8. Cahn A, Mehta R, Preece A, et al. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled oncedaily umeclidinium in healthy adults deficient in CYP2D6 activity: a doubleblind, randomized clinical trial. Clin drug Invest 2013;33(9):653-64
9. Donohue JF, Anzueto A, Brooks J, et al. A randomized, double-blind, doseranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med 2012;106:970-9.
10. Dose ranging trial.
11. Cahn A, Lovick R, Newlands A, et al. Safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of GSK573719 in healthy subjects. Eur Respir J 2011;38(Suppl 55):723
12. Mehta R, Hardes K, Cahn A, et al. Safety, tolerability and pharmacokinetics (PK) of repeated doses of GSK573719 Inhalation Powder, a new long-acting muscarinic antagonist, in healthy adults. Eur Respir J 2011;38(55):P3972
13. Decramer M, Maltais F, Feldman G, et al. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol 2013;185:393-9
14. Trivedi R, Richard N, Mehta R, et al. Umeclidinium inpatients with COPD: a randomised, placebo-controlled study. Eur Respir J 2014;43:72-81.
15. Recent placebo-controlled 12- week RCT.
16. Church A, Beerahee M, Brooks J, et al. Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study. BMC Pulm Med 2014;14:2
17. Tal-Singer R, Cahn T, Mehta R, et al. Initial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: two randomized studies. Eur J Pharmacol 2013;701:40-8
18. Donohue J, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med 2013;107(10):1538-46
19. Mahler DA, Witek TJ Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD 2005;2:99-103
20. Jones PW, Quirk FH, Baveystock CM, et al. A self-complete measure of health status for chronic airflow limitation.The St. George’s Respiratory Questionnaire. Am Rev Respir Dis 1992;145:1321-7
21. Tashkin DP, Celli B, Senn S, et al. A 4- year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-54
22. Chan CK, Maltais F, Sigouin C, et al. A randomized controlled trial to assess the efficacy of tiotropium in Canadian patients with chronic obstructive pulmonary disease. Can Respir J 2007;14:465-72
23. Price D, Fromer L, Kaplan A, et al. Is there a rationale and role for long-acting anticholinergic bronchodilators in asthma? NPJ Prim Care Respir Med 2014;24:14023
24. Kelleher D, Tombs L, Preece A, et al. A randomized, placebo-and moxifloxacincontrolled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects. Pulm Pharmacol Ther 2014;29(1):49-57
25. Mehta R, Hardes K, Kelleher D, et al. Effects of moderate hepatic impairment on the pharmacokinetic properties and tolerability of umeclidinium and vilanterol in inhalational umeclidinium monotherapy and umeclidinium/ vilanterol combination therapy: an openlabel, nonrandomized study. Clin Ther 2014;36(7):1016-27
26. Goyal N, Beerahee M, Kalberg C, et al. Population pharmacokinetics of inhaled umeclidinium and vilanterol in patients with chronic obstructive pulmonary disease. Clin Pharmacokinet 2014;53(7):637-48
27. Looks into pharmacokinetics of umeclidinium in special populations.
28. Toy EL, Beaulieu NU, McHale JM, et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med 2011;105(3):435-41
29. Mahler DA, D’Urzo A, Bateman ED, et al. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax 2012;67:781-8