Indacaterol/glycopyrronium bromide fixed-dose combination for the treatment of copd

Drugs of Today

Volumn 49, Issue 7, 2013, Pages 437-446

  Schachter, E N ^a  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Anticholinergic; B2 Adrenoceptor agonist; Chronic obstructive pulmonary disease (COPD); Indacaterol glycopyrronium bromide; QVA 149

Indexed keywords

ABEDITEROL; ACLIDINIUM BROMIDE; AZD 3199; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CARMOTEROL; FLUTICASONE FUROATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; FORMOTEROL; GLYCOPYRRONIUM BROMIDE; INDACATEROL; INDACATEROL PLUS GLYCOPYRRONIUM BROMIDE; MUSCARINIC RECEPTOR BLOCKING AGENT; NEOSTIGMINE; OLODATEROL; ORCIPRENALINE; PF 610355; PLACEBO; PYRIDOSTIGMINE; QVA 149; SALMETEROL; TIOTROPIUM BROMIDE; UNCLASSIFIED DRUG; VILANTEROL;

ARTICLE; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; FORCED EXPIRATORY VOLUME; HUMAN; PATIENT COMPLIANCE; PRACTICE GUIDELINE; TREATMENT OUTCOME;

Β2-ADRENOCEPTOR AGONIST; ANTICHOLINERGIC; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); INDACATEROL/GLYCOPYRRONIUM BROMIDE; QVA-149;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; DRUG COMBINATIONS; GLYCOPYRROLATE; HUMANS; INDANS; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES;

EID: 84882404527     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2013.49.7.1980496     Document Type: Article

References (51)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. http://www.goldcopd.org/. Accessed July 23, 2013.
2. Lehnert, B.E., Schachter, E.N. The Pharmacology of Respiratory Care. CV Mosby: St. Louis 1980, pp. 117-43.
3. Green, S.A., Spasoff, A.P., Coleman, R.A., Johnson, M., Liggett, S.B. Sustained activation of a G protein-coupled receptor via "anchored" agonist binding. Molecular localization of the salmeterol exosite within the 2-adrenergic receptor. J Biol Chem 1996, 271(39): 24029-35.
4. Anderson, G.P., Linden, A., Rabe, K.F. Why are long-acting beta-adrenoceptor agonists long-acting? Eur Respir J 1994, 7(3): 569-78.
5. Cazzola, M., Santangelo, G., Piccolo, A., Salzillo, A., Matera, M.G., D'Amato, G., Rossi, F. Effect of salmeterol and formoterol in patients with chronic obstructive pulmonary disease. Pulm Pharmacol 1994, 7(2): 103-7.
6. Cazzola, M., Matera, M.G., Santangelo, G., Vinciguerra, A., Rossi, F., D'Amato, G. Salmeterol and formoterol in partially reversible severe chronic obstructive pulmonary disease: a dose-response study. Respir Med 1995, 89(5): 357-62.
7. Cazzola, M., Grella, E., Matera, M.G., Mazzarella, G., Marsico, S.A. Onset of action following formoterol Turbuhaler and salbutamol pMDI in reversible chronic airway obstruction. Pulm Pharmacol Ther 2002, 15(2): 97-102.
8. Cazzola, M., D'Amato, M., Califano, C., Di Perna, F., Calderaro, E., Matera, M.G., D'Amato, G. Formoterol as dry powder oral inhalation compared with salbutamol metereddose inhaler in acute exacerbations of chronic obstructive pulmonary disease. Clin Ther 2002, 24(4): 595-604.
9. Tattersfield, A.E. Clinical pharmacology of long-acting betareceptor agonists. Life Sci 1993, 52(26): 2161-9.
10. Malerba, M., Radaeli, A., Morjaria, J.B. Therapeutic potential for novel ultra long-acting beta2-agonists in the management of COPD: biological and pharmacological aspects. Drug Discov Today 2012, 17(9-10): 496-504.
11. Cazzola, M., Page, C.P., Calzetta, L., Matera, M.G. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev 2012, 64(3): 450-504.
12. Schachter, E.N. New beta(2)-adrenoceptor agonists for the treatment of chronic obstructive pulmonary disease. Drugs Today (Barc) 2010, 46(12): 911-8.
13. Battram, C., Charlton, S.J., Cuenoud, B. et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1- hydroxy-ethyl]-8-hydroxy-1Hquinolin-2-o ne (indacaterol), a novel inhaled beta(2) adrenoceptor agonist with a 24-h duration of action. J Pharmacol Exp Ther 2006, 317(2): 762-70.
14. Sturton, R.G., Trifilieff, A., Nicholson, A.G., Barnes, P.J. Pharmacological characterization of indacaterol, a novel once daily inhaled 2 adrenoceptor agonist, on small airways in human and rat precision-cut lung slices. J Pharmacol Exp Ther 2008, 324(1): 270-5.
15. Lombardi, D., Cuenoud, B., Kramer, S.D. Lipid membrane interactions of indacaterol and salmeterol: do they influence their pharmacological properties? Eur J Pharm Sci 2009, 38(5): 533-47.
16. Renard, D., Looby, M., Kramer, B., Lawrence, D., Morris, D., Stanski, D.R. Characterization of the bronchodilatory dose response to indacaterol in patients with chronic obstructive pulmonary disease using model-based approaches. Respir Res 2011, 12: 54.
17. Balint, B., Watz, H., Amos, C., Owen, R., Higgins, M., Kramer, B. Onset of action of indacaterol in patients with COPD: comparison with salbutamol and salmeterol-fluticasone. Int J Chron Obstruct Pulmon Dis 2010, 5: 311-8.
18. Dahl, R., Chung, K.F., Buhl, R. et al. Efficacy of a new oncedaily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010, 65(6): 473-9.
19. Donohue, J.F., Fogarty, C., Lotvall, J. et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010, 182(2): 155-62.
20. Feldman, G., Siler, T., Prasad, N. et al. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med 2010, 10: 11.
21. Beier, J., Chanez, P., Martinot, J.B. et al. Safety, tolerability and efficacy of indacaterol, a novel once-daily beta(2)-agonist, in patients with COPD: a 28-day randomised, placebo controlled clinical trial. Pulm Pharmacol Ther 2007, 20(6): 740-9.
22. Beier, J., Beeh, K.M., Brookman, L., Peachey, G., Hmissi, A., Pascoe, S. Bronchodilator effects of indacaterol and formoterol in patients with COPD. Pulm Pharmacol Ther 2009, 22(6): 492-6.
23. Witek, T.J., Schachter, E.N. Pharmacology and Therapeutics in Respiratory Care. WB Saunders: Philadelphia 1994, pp. 167-82.
24. van Noord, J.A., Bantje, T.A., Eland, M.E., Korducki, L., Cornelissen, P.J. A randomised controlled comparison of tiotropium nd ipratropium in the treatment of chronic obstructive pulmonary disease. The Dutch Tiotropium Study Group. Thorax 2000, 55(4): 289-94.
25. Karner, C., Chong, J., Poole, P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012, 7: CD009285.
26. Cazzola, M. Aclidinium bromide, a novel long-acting muscarinic M3 antagonist for the treatment of COPD. Curr Opin Investig Drugs 2009, 10(5): 482-90.
27. Kerwin, E.M., D'Urzo, A.D., Gelb, A.F., Lakkis, H., Garcia Gil, E., Caracta, C.F. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012, 9(2): 90-101.
28. Jones, P.W., Singh, D., Bateman, E.D. et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J 2012, 40(4): 830-6.
29. Mak, G., Hanania, N.A. New bronchodilators. Curr Opin Pharmacol 2012, 12(3): 238-45.
30. Fogarty, C., Hattersley, H., Di Scala, L., Drollmann, A. Bronchodilatory effects of NVA237, a once daily long-acting muscarinic antagonist, in COPD patients. Respir Med 2011, 105(3): 337-42.
31. Verkindre, C., Fukuchi, Y., Flemale, A., Takeda, A., Overend, T., Prasad, N., Dolker, M. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir Med 2010, 104(10): 1482-9.
32. Casarosa, P., Bouyssou, T., Germeyer, S., Schnapp, A., Gantner, F., Pieper, M. Preclinical evaluation of long-acting muscarinic antagonists: comparison of tiotropium and investigational drugs. J Pharmacol Exp Ther 2009, 330(2): 660-8.
33. D'Urzo, A., Ferguson, G.T., van Noord, J.A. et al. Efficacy and safety of once-daily NVA237 in patients with moderate-tosevere COPD: the GLOW1 trial. Respir Res 2011, 12: 156.
34. Beeh, K.M., Singh, D., Di Scala, L., Drollmann, A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis 2012, 7: 503-13.
35. Novartis receives European Commission approval for oncedaily Seebri(R) Breezhaler(R) as maintenance COPD treatment in the EU [news release]. Novartis, October 1, 2012. Accessed July 23, 2013.
36. Cazzola, M., Molimard, M. The scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010, 23(4): 257-67.
37. COMBIVENT Inhalation Aerosol Study Group In chronic obstructive pulmonary disease, a combination of ipratropium and albuterol is more effective than either agent alone. An 85-day multicenter trial. COMBIVENT Inhalation Aerosol Study Group. Chest 1994, 105(5): 1411-9.
38. The COMBIVENT Inhalation Solution Study Group. Routine nebulized ipratropium and albuterol together are better than either alone in COPD. The COMBIVENT Inhalation Solution Study Group. Chest 1997, 112(6): 1514-21.
39. Gross, N., Tashkin, D., Miller, R., Oren, J., Coleman, W., Linberg, S. Inhalation by nebulization of albuterol-ipratropium combination (Dey combination) is superior to either agent alone in the treatment of chronic obstructive pulmonary disease. Dey Combination Solution Study Group. Respiration 1998, 65(5): 354-62.
40. D'Urzo, A.D., De Salvo, M.C., Ramirez-Rivera, A., Almeida, J., Sichletidis, L., Rapatz, G., Kottakis, J. In patients with COPD, treatment with a combination of formoterol and ipratropium is more effective than a combination of salbutamol and ipratropium: a 3-week, randomized, double-blind, within-patient, multicenter study. Chest 2001, 119(5): 1347-56.
41. van Noord, J.A., de Munck, D.R., Bantje, T.A., Hop, W.C., Akveld, M.L., Bommer, A.M. Long-term treatment of chronic obstructive pulmonary disease with salmeterol and the additive effect of ipratropium. Eur Respir J 2000, 15(5): 878-85.
42. Cazzola, M., Di Marco, F., Santus, P., Boveri, B., Verga, M., Matera, M.G., Centanni, S. The pharmacodynamic effects of single inhaled doses of formoterol, tiotropium and their combination in patients with COPD. Pulm Pharmacol Ther 2004, 17(1): 35-9.
43. van Noord, J.A., Aumann, J.L., Janssens, E., Verhaert, J., Smeets, J.J., Mueller, A., Cornelissen, P.J. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest 2006, 129(3): 509-17.
44. Mahler, D.A., D'Urzo, A., Bateman, E.D. 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(9): 781-8.
45. van Noord, J.A., Aumann, J.L., Janssens, E. et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005, 26(2): 214-22.
46. Matera, M.G., Page, C.P., Cazzola, M. Novel bronchodilators for the treatment of chronic obstructive pulmonary disease. Trends Pharmacol Sci 2011, 32(8): 495-506.
47. Van de Maele, B., Fabbri, L.M., Martin, C., Horton, R., Dolker, M., Overend, T. Cardiovascular safety of QVA149, a combination of Indacaterol and NVA237, in COPD patients. COPD 2010, 7(6): 418-27.
48. van Noord, J.A., Buhl, R., Laforce, C., Martin, C., Jones, F., Dolker, M., Overend, T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax 2010, 65(12): 1086-91.
49. Wedzicha, J.A., Decramer, M., Ficker, J.H. 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.
50. QVA149 filed as a once-daily maintenance treatment for COPD in Europe [news release]. Sosei, October 25, 2012. Accessed July 23, 2013.
51. Novartis first in class once-daily dual bronchodilator Ultibro® Breezhaler® (QVA149) gains positive CHMP opinion for the treatment of COPD [news release]. Novartis, July 26, 2013. Accessed July 29, 2013.