Long-acting β2-agonists in asthma: Not so SMART?

Drug Safety

Volumn 29, Issue 8, 2006, Pages 647-656

  Currie, Graeme P ^a   Lee, Daniel K C ^b   Lipworth, Brian J ^c  

^a ABERDEEN ROYAL INFIRMARY   (United Kingdom)

^b PAPWORTH HOSPITAL   (United Kingdom)

^c PERTH ROYAL INFIRMARY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BUDESONIDE; CORTICOSTEROID DERIVATIVE; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; FORMOTEROL; LONG ACTING DRUG; SALBUTAMOL; SALMETEROL; SALMETEROL XINAFOATE; BETA 2 ADRENERGIC RECEPTOR; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; DRUG DERIVATIVE;

AFRICAN AMERICAN; ASTHMA; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECT; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG SENSITIVITY; DRUG USE; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GENETIC PREDISPOSITION; GENOTYPE; HUMAN; INFLAMMATION; INHALER; META ANALYSIS; MORTALITY; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SYSTEMATIC REVIEW; TREATMENT OUTCOME; UNITED STATES; CONTROLLED CLINICAL TRIAL; DELAYED RELEASE FORMULATION; DRUG POTENTIATION; INHALATIONAL DRUG ADMINISTRATION; MULTICENTER STUDY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-AGONISTS; ALBUTEROL; ASTHMA; DELAYED-ACTION PREPARATIONS; DRUG LABELING; EVIDENCE-BASED MEDICINE; HUMANS; MULTICENTER STUDIES; PRACTICE GUIDELINES; RANDOMIZED CONTROLLED TRIALS; RECEPTORS, ADRENERGIC, BETA-2;

EID: 33746825804     PISSN: 01145916     EISSN: 01145916     Source Type: Journal    
DOI: 10.2165/00002018-200629080-00002     Document Type: Review

References (67)

1. Currie GP, Lee DK, Wilson AM. Effects of dual therapy with corticosteroids plus long acting beta(2)-agonists in asthma. Respir Med 2005; 99: 683-94
2. GINA Workshop Report, Global Strategy for Asthma Management and Prevention - updated 2004. Scientific information and recommendations for asthma programs. NIH Publication No. 02-3659
3. British Thoracic Society; Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Thorax 2003; 58 Suppl. 1: i1-94
4. Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006; 129: 15-26
5. SLGA5011: a double-blind, randomized, placebo-controlled surveillance study of asthma event outcomes in subjects receiving either usual pharmacotherapy of asthma or usual pharmacotherapy plus salmeterol 42μg twice daily [online]. Available from URL: http://www.ctr.gsk.co.uk/Summary/ salmeterol/studylist.asp [Accessed 2005 Dec 7]
6. Mann M, Chowdhury B, Sullivan E, et al. Serious asthma exacerbations in asthmatics treated with high-dose formoterol. Chest 2003; 124: 70-4
7. Lipworth BJ. Airway subsensitivity with long-acting beta 2-agonists: is there cause for concern? Drug Saf 1997; 16: 295-308
8. Lipworth B, Tan S, Devlin M, et al. Effects of treatment with formoterol on bronchoprotection against methacholine. Am J Med 1998; 104: 431-8
9. Aziz I, Tan KS, Hall IP, et al. Subsensitivity to bronchoprotection against adenosine monophosphate challenge following regular once-daily formoterol. Eur Respir J 1998; 12: 580-4
10. Kalra S, Swystun VA, Bhagat R, et al. Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol. Chest 1996; 109: 953-6
11. Grove A, Lipworth BJ. Bronchodilator subsensitivity to salbutamol after twice daily salmeterol in asthmatic patients. Lancet 1995; 346: 201-6
12. Currie GP, Jackson CM, Ogston SA, et al. Airway-stabilizing effect of long-acting beta2-agonists as add-on therapy to inhaled corticosteroids. Q J Med 2003; 96: 435-40
13. Green SA, Turki J, Bejarano P, et al. Influence of beta 2-adrenergic receptor genotypes on signal transduction in human airway smooth muscle cells. Am J Respir Cell Mol Biol 1995; 13: 25-33
14. Tan S, Hall IP, Dewar J, et al. Association between beta 2-adrenoceptor polymorphism and susceptibility to bronchodilator desensitisation in moderately severe stable asthmatics. Lancet 1997; 350: 995-9
15. Lipworth BJ, Dempsey OJ, Aziz I. Functional antagonism with formoterol and salmeterol in asthmatic patients expressing the homozygous glycine-16 beta(2)-adrenoceptor polymorphism. Chest 2000; 118: 321-8
16. Wechsler ME, Lehman E, Lazarus SC, et al. beta-Adrenergic receptor polymorphisms and response to salmeterol. Am J Respir Crit Care Med 2006; 173: 519-26
17. Lee DK, Currie GP, Hall IP, et al. The arginine-16 beta2-adrenoceptor polymorphism predisposes to bronchoprotective subsensitivity in patients treated with formoterol and salmeterol. Br J Clin Pharmacol 2004; 57: 68-75
18. Xie HG, Stein CM, Kim RB, et al. Frequency of functionally important beta-2 adrenoceptor polymorphisms varies markedly among African-American, Caucasian and Chinese individuals. Pharmacogenetics 1999; 9: 511-6
19. McIvor RA, Pizzichini E, Turner MO, et al. Potential masking effects of salmeterol on airway inflammation in asthma. Am J Respir Crit Care Med 1998; 158: 924-30
20. Nials AT, Ball DI, Butchers PR, et al. Formoterol on airway smooth muscle and human lung mast cells: a comparison with salbutamol and salmeterol. Eur J Pharmacol 1994; 251: 127-35
21. Chong LK, Cooper E, Vardey CJ, et al. Salmeterol inhibition of mediator release from human lung mast cells by beta-adrenoceptor-dependent and independent mechanisms. Br J Pharmacol 1998; 123: 1009-15
22. Erjefalt I, Persson CG. Long duration and high potency of antiexudative effects of formoterol in guinea-pig tracheobronchial airways. Am Rev Respir Dis 1991; 144: 788-91
23. Bolton PB, Lefevre P, McDonald DM. Salmeterol reduces early- and late-phase plasma leakage and leukocyte adhesion in rat airways. Am J Respir Crit Care Med 1997; 155: 1428-35
24. Verleden GM, Belvisi MG, Rabe KF, et al. Beta 2-adrenoceptor agonists inhibit NANC neural bronchoconstrictor responses in vitro. J Appl Physiol 1993; 74: 1195-9
25. Calhoun WJ, Hinton KL, Kratzenberg JJ. The effect of salmeterol on markers of airway inflammation following segmental allergen challenge. Am J Respir Crit Care Med 2001; 163: 881-6
26. Gardiner PV, Ward C, Booth H, et al. Effect of eight weeks of treatment with salmeterol on bronchoalveolar lavage inflammatory indices in asthmatics. Am J Respir Crit Care Med 1994; 150: 1006-11
27. Lazarus SC, Boushey HA, Fahy JV, et al. Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. JAMA 2001; 285: 2583-93
28. Wallin A, Sue-Chu M, Bjermer L, et al. Effect of inhaled fluticasone with and without salmeterol on airway inflammation in asthma. J Allergy Clin Immunol 2003; 112: 72-8
29. Li X, Ward C, Thien F, et al. An antiinflammatory effect of salmeterol, a long-acting beta(2) agonist, assessed in airway biopsies and bronchoalveolar lavage in asthma. Am J Respir Crit Care Med 1999; 160: 1493-9
30. Wallin A, Sandstrom T, Soderberg M, et al. The effects of regular inhaled formoterol, budesonide, and placebo on mucosal inflammation and clinical indices in mild asthma. Am J Respir Crit Care Med 1999; 159: 79-86
31. Lemanske RF, Sorkness CA, Mauger EA, et al. Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: a randomized controlled trial. JAMA 2001; 285: 2594-603
32. Roth M, Johnson PR, Rudiger JJ, et al. Interaction between glucocorticoids and beta2 agonists on bronchial airway smooth muscle cells through synchronised cellular signalling. Lancet 2002; 360: 1293-9
33. Eickelberg O, Roth M, Lorx R, et al. Ligand-independent activation of the glucocorticoid receptor by beta2-adrenergic receptor agonists in primary human lung fibroblasts and vascular smooth muscle cells. J Biol Chem 1999; 274: 1005-10
34. Usmani OS, Ito K, Maneechotesuwan K, et al. Glucocorticoid receptor nuclear translocation in airway cells after inhaled combination therapy. Am J Respir Crit Care Med 2005; 172: 704-12
35. Orsida BE, Ward C, Li X, et al. Effect of a long-acting beta2-agonist over three months on airway wall vascular remodeling in asthma. Am J Respir Crit Care Med 2001; 164: 117-21
36. Adcock IM, Maneechotesuwan K, Usmani O. Molecular interactions between glucocorticoids and long-acting beta2-agonists. J Allergy Clin Immunol 2002; 110: S261-8
37. Mak JC, Hisada T, Salmon M, et al. Glucocorticoids reverse IL-1beta-induced impairment of beta-adrenoceptor-mediated relaxation and up-regulation of G-protein-coupled receptor kinases. Br J Pharmacol 2002; 135: 987-96
38. Kavuru M, Melamed J, Gross G, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000; 105: 1108-16
39. Shapiro G, Lumry W, Wolfe J, et al. Combined salmeterol 50 microg and fluticasone propionate 250 microg in the diskus device for the treatment of asthma. Am J Respir Crit Care Med 2000; 161: 527-34
40. Currie GP, Bates CE, Lee DK, et al. Effects of fluticasone plus salmeterol versus twice the dose of fluticasone in asthmatic patients. Eur J Clin Pharmacol 2003; 59: 11-5
41. Currie GP, Lee DK, Haggart K, et al. Effects of montelukast on surrogate inflammatory markers in corticosteroid-treated patients with asthma. Am J Respir Crit Care Med 2003; 167: 1232-8
42. Aziz I, Wilson AM, Lipworth BJ. Effects of once-daily formoterol and budesonide given alone or in combination on surrogate inflammatory markers in asthmatic adults. Chest 2000; 118: 1049-58
43. Lee DK, Jackson CM, Currie GP, et al. Comparison of combination inhalers vs inhaled corticosteroids alone in moderate persistent asthma. Br J Clin Pharmacol 2003; 56: 494-500
44. Lee DK, Jackson CM, Bates CE, et al. Cross tolerance to salbutamol occurs independently of beta2 adrenoceptor genotype-16 in asthmatic patients receiving regular formoterol or salmeterol. Thorax 2004; 59: 662-7
45. van der Woude HJ, Winter TH, Aalbers R. Decreased bronchodilating effect of salbutamol in relieving methacholine induced moderate to severe bronchoconstriction during high dose treatment with long acting beta2 agonists. Thorax 2001; 56: 529-35
46. van Veen A, Weller FR, Wierenga EA, et al. A comparison of salmeterol and formoterol in attenuating airway responses to short-acting beta2-agonists. Pulm Pharmacol Ther 2003; 16: 153-61
47. Fuglsang G, Vikre-Jorgensen J, Agertoft L, et al. Effect of salmeterol treatment on nitric oxide level in exhaled air and dose-response to terbutaline in children with mild asthma. Pediatr Pulmonol 1998; 25: 314-21
48. Lipworth BJ, Aziz I. A high dose of albuterol does not overcome bronchoprotective subsensitivity in asthmatic subjects receiving regular salmeterol or formoterol. J Allergy Clin Immunol 1999; 103: 88-92
49. Jones SL, Cowan JO, Flannery EM, et al. Reversing acute bronchoconstriction in asthma: the effect of bronchodilator tolerance after treatment with formoterol. Eur Respir J 2001; 17: 368-73
50. Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med 2004; 170: 836-44
51. Currie GP, Lee DK. The GOAL study: designed to favor a long-acting beta2-agonist? Am J Respir Crit Care Med 2005; 171: 1060-1
52. Fardon TC, Lipworth BJ. An own GOAL or a real breakthrough? Am J Respir Crit Care Med 2005; 171: 1060
53. Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA). BMJ 2000; 320: 1368-73
54. Masoli M, Weatherall M, Holt S, et al. Moderate dose inhaled corticosteroids plus salmeterol versus higher doses of inhaled corticosteroids in symptomatic asthma. Thorax 2005; 60: 730-4
55. Barnes ML, Lipworth BJ. Clinical importance of the Step 3 choice in asthma. Thorax 2006; 61: 180-1
56. Pauwels RA, Lofdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl J Med 1997; 337: 1405-11
57. Ward C, Pais M, Bish R, et al. Airway inflammation, basement membrane thickening and bronchial hyperresponsiveness in asthma. Thorax 2002; 57: 309-16
58. Reddel HK, Jenkins CR, Marks GB, et al. Optimal asthma control, starting with high doses of inhaled budesonide. Eur Respir J 2000; 16: 226-35
59. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med 1999; 159: 941-55
60. Bousquet J, Jeffery PK, Busse WW, et al. Asthma. From bronchoconstriction to airways inflammation and remodeling. Am J Respir Crit Care Med 2000; 161: 1720-45
61. Holt S, Suder A, Weatherall M, et al. Dose-response relation of inhaled fluticasone propionate in adolescents and adults with asthma: meta-analysis. BMJ 2001; 323: 253-6
62. Currie GP, Fowler SJ, Lipworth BJ. Dose response of inhaled corticosteroids on bronchial hyperresponsiveness: a meta-analysis. Ann Allergy Asthma Immunol 2003; 90: 194-8
63. Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet 2005; 366: 1261-2
64. O'Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial. Am J Respir Crit Care Med 2001; 164: 1392-7
65. Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet 2003; 361: 1071-6
66. Currie GP, Lee DK, Srivastava P. Long-acting bronchodilator or leukotriene modifier as add-on therapy to inhaled corticosteroids in persistent asthma? Chest 2005; 128: 2954-62
67. Martinez FD. Safety of long-acting beta-agonists: an urgent need to clear the air. N Engl J Med 2005; 353: 2637-9