Безопасность длительнодействующих β₂-агонистов при бронхиальной астме

1. Nelson H. Beta adrenergic bronchodilators. N. Engl. J. Med. 1995; 333: 499–506.

2. Moore R.H., Khan A., Dickey B.F. Long acting inhaled β2-agonists in asthma therapy. Chest 1998; 113: 1095–1108.

3. Kips J.C., Pauwels R.A. Long acting inhaled β2-agonist ther apy in asthma. Am. J. Respir. Crit. Care Med. 2001; 164: 923–932.

4. Sears M.R. Adverse effects of β agonists. J. Allergy Clin. Immunol. 2002; 110 (6, suppl.): S322–328.

5. Hasford J., Virchow J.C. Excess mortality in patients with asthma on long acting β 2 agonists. Eur. Respir. J. 2006; 28: 900–902.

6. Sears M.R., Taylor D.R. The β 2 agonist controversy: obser vations, explanations and relationship to asthma epidemiol ogy. Drug. Safety 1994; 11: 259–283.

7. Stolley P.D., Schinnar R. Association between asthma mor tality and isoproterenol aerosols: a review. Prev. Med. 1978; 7: 519–538.

8. Pearce N.E., Grainger J., Atkinson M. Case control study of prescribed fenoterol and death from asthma in New Zealand, 1977–1981. Thorax 1990; 45: 170–175.

9. Spitzer W.O., Suissa S., Ernst P. et al. The use of β agonists and the risk of death and near death from asthma. N. Engl. J. Med. 1992; 326: 501–506.

10. Garrett J., Kolbe J., Richards G. et al. Major reduction in asthma morbidity and continued reduction in asthma mor tality in New Zealand; what lessons have been learned? Thorax 1995; 50: 303–311.

11. Johnson M., Butchers Pr., Colman R.A. et al. The pharma cology of salmeterol. Life Sci. 1993; 52: 2131–2143.

12. Anderson G.P. Formoterol: pharmacology, molecular basis of agonism, and mechanism of long duration of a highly potent and selective β 2 adrenoceptor agonist bronchodila tor. Life Sci. 1993; 52: 2145–2160.

13. Pearlman D., Chervinsky P., LaForce C. et al. A comparison of salmeterol with albuterol in the treatment of mild to moderate asthma. N. Engl. J. Med. 1992; 327: 1420–1425.

14. D'Alonzo G.E., Nathan R.A., Henochowicz S. et al. Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma. J.A.M.A. 1994; 271: 1412–1416.

15. Fitzgerald J.M., Chapman K.R., Della Cioppa G. et al. Sustained bronchoprotection, bronchodilation, and symp tom control during regular formoterol use in asthma of moderate or greater severity. J. Allergy Clin. Immunol. 1999; 103: 427–434.

16. Bensch G., Lapidus R.J., Levine B.E. et al. A randomized, 12 week, double blind, placebo controlled study compar ing formoterol dry powder inhaler with albuterol metered dose inhaler. Ann. Allergy Asthma Immunol. 2001; 86: 19–27.

17. Shrewsbury S., Pyke S., Britton M. Meta analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA). Br. Med. J. 2000; 320: 1368–1373.

18. O'Byrne P.M., Barnes P.J., Rodriquez1Rotsin 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: 1192–1197.

19. Nelson H.S., Chapman K.R., Pyke S.D. et al. Enhanced syn ergy between fluticasone propionate and salmeterol inhaled from a single inhaler versus separate inhalers. J. Allergy Clin. Immunol. 2003; 112: 29–36.

20. Bateman E.D., Boushey H.A., Bousquet J. et al. Can guide line define asthma control be achieved? The gaining opti mal asthma control study. Am. J. Respir. Crit. Care Med. 2004; 170: 836–844.

21. Price D., Dutchman D., Mawson A. et al. Early asthma con trol and maintenance with eformoterol following reduction of inhaled corticosteroid dose. Thorax 2002; 57: 791–798.

22. Pauwels R., Lofdahl C.G., Postma D.S. et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET). N. Engl. J. Med. 1998; 338: 1405–1411.

23. Fitzgerald J.M., Chapman K.R., Della Cioppa G.B. et al. Sustained bronchoprotection, bronchodilation and symp tom control during regular formoterol use in asthma of moderate or greater severity. J. Allergy Clin. Immunol. 1999; 103: 427–435.

24. Britton M.G., Earnshaw J.S., Palmer J.B.D. A twelve month comparison of salmeterol with salbutamol in asthmatic patients. Eur. Respir. J. 1992; 5: 1062–1067.

25. Korosec M., Novak R.D., Myers E. et al. Salmeterol does not compromise the bronchodilator response to albuterol during acute episodes of asthma. Am. J. Med. 1999; 107: 209–213.

26. Ullman A., Hedner J., Svedmyr N. Inhaled salmeterol and salbutamol in asthmatic patients. Am. Rev. Respir. Dis. 1990; 142: 571–575.

27. Yates D.H., Sussman H.S., Shaw M.J. et al. Regular for moterol treatment in mild asthma: effect on bronchial responsiveness during and after treatment. Am. J. Respir. Crit. Care Med. 1995; 152: 1170–1174.

28. Booth H., Fishwick K., Harkawat R., et al. Changes in methacholine induced bronchoconstriction with the long acting β 2 agonist salmeterol in mild to moderate asthmatic patients. Thorax 1993; 48: 1121–1124.

29. Cheung D., Timmers M.C., Zwinderman A.H. et al. Long term effects of a long acting β 2 adrenoceptor agonist, sal meterol, on airway hyperresponsiveness in patients with mild asthma. N. Engl. J. Med. 1992; 327: 1196–1203.

30. Kalra S., Swystun V.A., Bhagat R., Cockcroft D.W. Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol. Chest 1996; 109: 953–956.

31. Ramage L., Lipworth B.J., Ingram C.G. et al. Reduce protec tion against exercise induced bronchoconstriction after chronic dosing with salmeterol. Respir. Med. 1994; 88: 363–836.

32. Garcia R., Guera P., Feo F. et al. Tachyphylaxis following regular use of formoterol in exercise induced bron chospasm. J. Invest. Allergol. Clin. Immunol. 2001; 11: 176–182.

33. Simons F.E., Gerstner T.V., Cheung M.S. Tolerance to the bronchoprotective effects of salmeterol in adolescent with exercise induced asthma using concurrent inhaled gluco corticoid treatment. Pediatrics 1997; 99: 655–659.

34. Burgess C., Ayson M., Rajasingham S. et al. The extrapul monary effects of increasing doses of formoterol in patients with asthma. Eur. J. Clin. Pharmacol. 1998; 54: 141–147.

35. Ferguson G.T., Funck1Brentano C., Fischer T. et al. Cardiovascular safety of salmeterol in COPD. Chest 2003; 123: 1817–1824.

36. Martin R.M., Dunn N.R., Freemantle S.N., Mann R.D. Risk of non fatal cardiac failure and ischemic heart disease with long acting β 2 agonists. Thorax 1998; 53: 558–572.

37. Taylor D.R., Town G.I., Herbison G.P. et al. Asthma control during long term treatment with regular inhaled salbutamol and salmeterol. Thorax 1998; 53: 744–752.

38. Taylor D.R., Drazen J.M., Herbison G.P. et al. Asthma exac erbations during long term b agonist use: influence of β 2 adrenoceptor polymorphism. Thorax 2000; 55: 762–767.

39. Dorinsky P., Yancey S., Edwards L. et al. Rates of asthma exacerbations are not effected by β 2 adrenergic receptor genotype in patients with persistent asthma. J. Allergy Clin. Immunol. 2005; 115 (suppl. 1): S6.

40. Kraft M., Wenzel S.E., Betting C.M., Martin R.J. The effect of salmeterol on nocturnal symptoms, airway function and inflammation in asthma. Chest 1997; 111: 1249–1254.

41. Roberts J.A., Bradding P., Britten K.M. et al. The long acting β 2 agonist salmeterol xinafoate: effects on airway inflamma tion in asthma. Eur. Respir. J. 1999; 14: 275–282.

42. Wallin A., Sandstrom T., Soderberg M. et al. The effect 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.

43. Jeffery P.K., Venge P., Gizycki M.J. et al. Effects of salme terol on mucosal inflammation in asthma: a placebocon trolled study. Eur. Respir. J. 2002; 20: 1378–1385.

44. Kips J.C., O'Connor B.J., Inman M.D. et al. A long term study of the anti inflammatory effect of low dose budes onide plus formoterol versus high dose budesonide in asth ma. Am. J. Respir. Crit. Care Med. 2000; 161: 996–1001.

45. Wallin Am Sue1Chu M., Bjermer I., Ward J. et al. Effect of inhaled fluticasone with and without salmeterol on airway inflammation in asthma. J. Allergy Clin. Immunol. 2003; 112: 72–78.

46. National Institutes of Health, National Heart, Lung and Blood Institute. Guidelines for the diagnosis and manage ment of asthma: update on selected topics 2002. J. Allergy Clin. Immunol. 2002; 110 (suppl.): S141–S219.

47. Lazarus S.C., Boushey H.A., Fahy J.V. et al. Long acting β 2 agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a ran domized controlled trial. J. A. M. A. 2001; 285: 2583–2593.

48. Simons F.E. A comparison of beclomethasone, salmeterol and placebo in children with asthma. N. Engl. J Med. 1997; 337: 1659–1665.

49. Verberne A.A., Frost C., Roorda R.J. et al. One year treat ment with salmeterol. Compared with beclomethasone in children with asthma. Am. J. Respir. Crit. Care Med. 1997; 156: 688–695.

50. McIvor R.A., Pizzichini E., Turner M.O. et al. Potential masking effects of salmeterol on airway inflammation in asthma. Am. J. Respir. Crit.Care Med. 1998; 158: 924–930.

51. Campbell D.A., McLennan G., Coates J.R. et al. A compari son of asthma deaths and near fatal asthma attack in South Australia. Eur. Respir. J. 1994; 7: 490–497.

52. Matz J., Emmett A., Rickard K., Kalberg C. Addition of sal meterol to low dose fluticasone versus higher dose fluticas one: an analysis of asthma exacerbations. J. Allergy Clin. Immunol. 2001; 107: 783–789.

53. Pace E., Gagliardo R., Melis M. et al. Synergistic effects of fluticasone propionate and salmeterol on in vitro T cell activation and apoptosis in asthma. J. Allergy Clin. Immunol. 2004; 114: 1216–1223.

54. Baraniuk J., Ali M., Brody D. et al. Glucocorticoids induce β 2 adrenergic receptor function in human nasal mucosa. Am. J. Respir. Crit. Care Med. 1997; 155: 704–710.

55. Eickelberg O., Roth M., Lorx R. et al. Ligand independent activation of glucocorticoid receptor by β 2 adrenergic receptor agonists in primary human lung fibroblasts and vas cular smooth muscle cells. J. Biol. Chem. 1999; 274: 1005–1010.

56. Wilkinson J.R.W., Roberts J.A., Bradding P. et al. Paradoxical bronchoconstriction in asthmatic patients after salmeterol by metered dose inhaled. B. J. M. 1992; 305: 931–932.

57. Clark C.E., Ferguson A.D., Siddorn J.A. Respiratory arrests in young asthmatics on salmeterol. Respir. Med. 1993; 87: 227–228.

58. Finkelstein F.N. Risks of salmeterol. N. Engl. J. Med. 1994; 331: 1314.

59. Mann R.D., Kubota K., Pearce G., Wilton L. Salmeterol: a study by prescription event monitoring in a UK cohort of 15,407 patients. J. Clin. Epidemiol. 1996; 49: 247–250.

60. Williams C., Crossland L., Finnerty J. et al. Case control study of salmeterol and near fatal attacks of asthma. Thorax 1998; 53: 7–13.

61. Castle W., Fuller R., Hall J., Palmer J. Serevent nationwide surveillance study: comparison of salmeterol with salbuta mol in asthmatic patients who require regular bronchodila tor treatment. B. M. J. 1993; 306: 1034–1037.

62. Nelson H.S., Weiss S.T., Bleecker E.R. et al. The salmeterol multicenter asthma research trial (SMART): a comparison of usual pharmacotherapy for asthma or usual pharma cotherapy plus salmeterol. Chest 2006; 129: 15–26.

63. FDA Public Health Advisory: Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), Foradil Aerolizer (formoterol fumarate inhalation powder). http://www.fda.gov/cder/drug/infopage/LABA/default.htm.

64. O'Byrne P., Adelroth E. β 2 Deja Vu. Chest 2006; 129: 3–5.

65. Salpeter S.R., Buckley N.S., Ormiston T.M., Salpeter E.E. Meta Analysis: effect of long acting β agonists on severe asthma exacerbations and asthma related deaths. Ann. Intern. Med. 2006; 144: 904–912.

66. Naline E., Zhang Y., Qian Y. et al. Relaxant effects and dura tion of action of formoterol and salmeterol on the isolated human bronchus. Eur. Respir. J. 1994; 7: 914–920.

67. Mann M., Chowdhury B., Sullivan E. et al. Serious asthma exacerbations in asthmatics treated with high dose for moterol. Chest 2003; 124: 70–74.

68. Wolfe J., LaForce C., Sokol W. et al. Formoteral 24 μg bid, and serious asthma exacerbations: similar rates compared with formoterol, 12 ?g bid, with and without extra doses taken on demand, and placebo. Chest 2006; 129: 27–38.