Pharmacologic characteristics and adrenal suppression with newer inhaled corticosteroids: A comparison of ciclesonide and fluticasone propionate

Clinical Therapeutics

Volumn 28, Issue 3, 2006, Pages 319-331

  Kaliner, Michael A ^a  

^a Institute for Asthma and Allergy   (United States)

Author keywords

adrenal suppression; asthma; ciclesonide; fluticasone propionate; inhaled corticosteroids

Indexed keywords

BECLOMETASONE; BECLOMETASONE DIPROPIONATE; BUDESONIDE; CICLESONIDE; CORTICOSTEROID; DEXAMETHASONE; DRUG METABOLITE; ESTERASE; FLUNISOLIDE; FLUTICASONE PROPIONATE; PEPTIDE; TRIAMCINOLONE ACETONIDE;

ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; ADRENAL DISEASE; ADRENAL INSUFFICIENCY; ADRENAL SUPPRESSION; ASTHMA; BINDING AFFINITY; CATARACT; CHRONIC BRONCHITIS; CLINICAL TRIAL; COMA; CONSCIOUSNESS DISORDER; COUGHING; DATA BASE; DRUG CLEARANCE; DRUG CONJUGATION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG EXPOSURE; DRUG FATALITY; DRUG HALF LIFE; DRUG PROTEIN BINDING; DRUG SAFETY; DYSPHONIA; EMBASE; EYE DISEASE; GLAUCOMA; HIP FRACTURE; HUMAN; HYPOGLYCEMIA; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; INTRAOCULAR HYPERTENSION; MEDLINE; MYOPATHY; OROPHARYNX CANDIDIASIS; PHARYNX DISEASE; PROTEIN BLOOD LEVEL; PURPURA; RECEPTOR BINDING; RESPIRATORY FUNCTION; REVIEW; SEIZURE; SKIN DISEASE; SYSTEMIC CIRCULATION; THRUSH; TIME SERIES ANALYSIS;

ADRENAL CORTEX HORMONES; ANDROSTADIENES; ASTHMA; HALF-LIFE; HUMANS; HYPOTHALAMO-HYPOPHYSEAL SYSTEM; METERED DOSE INHALERS; PITUITARY-ADRENAL SYSTEM; PREGNENEDIONES;

EID: 33646866965     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.03.003     Document Type: Review

References (101)

1. July. National Asthma Education and Prevention Program. Expert Panel Report 2. Guidelines for the Diagnosis and Management of Asthma. Accessed April 15, 2005 (1997). http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf Accessed April 15, 2005
2. Derendorf H., Hochhaus G., Meibohm B., et al. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol. 101 (1998) S440-S446
3. Kelly H.W. Establishing a therapeutic index for the inhaled corticosteroids: Part I. Pharmacokinetic/ pharmacodynamic comparison of the inhaled corticosteroids. J Allergy Clin Immunol. 102 (1998) S36-S51
4. Derendorf H. Pharmacokinetic and pharmacodynamic properties of inhaled corticosteroids in relation to efficacy and safety. Respir Med. 91 Suppl A (1997) 22-28
5. NIH publication 95-3659. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. NHLBI/WHO Workshop Report (1995), NIH, Bethesda, Md
6. Barnes P.J., Pedersen S., and Busse W.W. Efficacy and safety of inhaled corticosteroids. New developments. Am J Respir Crit Care Med. 157 (1998) S1-S53
7. Toogood J.H. Inhaled steroid asthma treatment: 'Primum non nocere'. Can Respir J. 5 Suppl A (1998) 50A-53A
8. Barnes P.J. Inhaled glucocorticoids for asthma. N Engl J Med. 332 (1995) 868-875
9. Williamson I.J., Matusiewicz S.P., Brown P.H., et al. Frequency of voice problems and cough in patients using pressurized aerosol inhaled steroid preparations. Eur Respir J. 8 (1995) 590-592
10. Lipworth B.J., and Seckl J.R. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 52 (1997) 476-482
11. Wolthers O.D., and Honour J.W. Measures of hypothalamicpituitary-ad renal function in patients with asthma treated with inhaled glucocorticoids: Clinical and researchimplications. J Asthma. 36 (1999) 477-486
12. Pescollderungg L., Radetti G., Gottardi E., et al. Systemic activity of inhaled corticosteroid treatment in asthmatic children: Corticotrophin releasing hormone test. Thorax 58 (2003) 227-230
13. Nelson H.S., Stricker W., Casale T.B., et al. A comparison of methods for assessing hypothalamic-pituitary-adrenal (HPA) axis activity in asthma patients treated with inhaled corticosteroids. J Clin Pharmacol. 42 (2002) 319-326
14. Crowley S. Inhaled glucocorticoids and adrenal function: An update. Paediatr Respir Rev. 4 (2003) 153-161
15. Thaler L.M., and Blevins Jr. L.S. The low dose (1-microg) adrenocorticotropin stimulation test in the evaluation of patients with suspected central adrenal insufficiency. J Clin Endocrinol Metab. 83 (1998) 2726-2729
16. Abdu T.A., Elhadd T.A., Neary R., and Clayton R.N. Comparison of the low dose short synacthen test (1 microg), the conventional dose short synacthen test (250 microg), and the insulin tolerance testfor assessment of the hypothalamopituitary-adrenal axis in patients with pituitary disease. J Clin Endocrinol Metab. 84 (1999) 838-843
17. Broide J., Soferman R., Kivity S., et al. Low-dose adrenocorticotropin test reveals impaired adrenal function in patients taking inhaled corticosteroids. J Clin Endocrinol Metab. 80 (1995) 1243-1246
18. Orth D.N., Kovacs W.J., and DeBold C.R. The adrenal cortex. In: Wilson J.D., and Foster D.W. (Eds). Williams Textbook of Endocrinology. 8th ed. (1992), WB Saunders, Philadelphia, Pa 489-619
19. Allen D.B., Bielory L., Derendorf H., et al. Inhaled corticosteroids: Past lessons and future issues. J Allergy Clin Immunol 112 Suppl 3 (2003) S1-S40
20. Todd G.R., Acerini C.L., Ross-Russell R., et al. Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom. Arch Dis Child. 87 (2002) 457-461
21. Drake A.J., Howells R.J., Shield J.P., et al. Symptomatic adrenal insufficiency presenting with hypoglycaemia in children with asthma receiving high dose inhaled fluticasone propionate. BMJ 324 (2002) 1081-1082
22. Dunlop K.A., Carson D.J., and Shields M.D. Hypoglycemia due to adrenal suppression secondary to high-dose nebulized corticosteroid. Pediatr Pulmonol. 34 (2002) 85-86
23. Konig P., Hillman L., Cervantes C., et al. Bone metabolism in children with asthma treated with inhaled beclomethasone dipropionate. J Pediatr 122 (1993) 219-226
24. Ali N.J., Capewell S., and Ward M.J. Bone turnover during high dose inhaled corticosteroid treatment. Thorax 46 (1991) 160-164
25. Hanania N.A., Chapman K.R., Sturtridge W.C., et al. Dose-related decrease in bone density among asth matic patients treated with inhaled corticosteroids. J Allergy Clin Immunol. 96 (1995) 571-579
26. Sivri A., and Coplu L. Effect of the longterm use of inhaled corticosteroids on bone mineral density in asthmatic women. Respirology. 6 (2001) 131-134
27. Israel E., Banerjee T.R., Fitzmaurice G.M., et al. Effects of inhaled glucocorticoids on bone density in premenopausal women. N Engl J Med. 345 (2001) 941-947
28. Kelly H.W., Strunk R.C., Donithan M., et al., Childhood Asthma Management Program (CAMP). Growth and bone density in children with mild-moderate asthma: A crosssectional study in children entering the Childhood Asthma Management Program (CAMP). J Pediatr. 142 (2003) 286-291
29. Harmanci E., Colak O., Metintas M., et al. Fluticasone propionate and budesonide do not influence bone metabolism in the long-term treatment of asthma. Allergol Immunopathol (Madr). 29 (2001) 22-27
30. Sharma P.K., Malhotra S., Pandhi P., and Kumar N. Effect of inhaled steroids on bone mineral density: A meta analysis. J Clin Pharmacol. 43 (2003) 193-197
31. Tattersfield A.E., Town G.I., Johnell O., et al. Bone mineral density in subjects with mild asthma randomised to treatment with inhaled corticosteroids or non-corticosteroid treatment for two years. Thorax 56 (2001) 272-278
32. Li J.T., Ford L.B., Chervinsky P., et al. Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2years in adults with mild asthma. J Allerg Clin Immunol. 103 (1999) 1062-1068
33. Kemp J.P., Osur S., Shrewsbury S.B., et al. Potential effects of fluticasone propionate on bone mineral density in patients with asthma: A 2-year randomized, double-blind, placebocontrolledtrial. Mayo Clin Proc. 79 (2004) 458-466
34. Hubbard R.B., Smith C.J., Smeeth L., et al. Inhaled corticosteroids and hip fracture: A population-based case control study. Am J Respir Crit Care Med. 166 (2002) 1563-1566
35. Suissa S., Baltzan M., Kremer R., and Ernst P. Inhaled and nasal corticosteroid use and the risk of fracture. Am J Respir Crit Care Med. 169 (2004) 83-88
36. Dreyer E.B. Inhaled steroid use and glaucoma. N Engl J Med. 329 (1993) 1822
37. Garbe E., LeLorier J., Boivin J.F., and Suissa S. Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. JAMA 277 (1997) 722-727
38. Mitchell P., Cumming R.G., and Mackey D.A. Inhaled corticosteroids, family history, and risk of glaucoma. Ophthalmology 106 (1999) 2301-2306
39. Opatowsky I., Feldman R.M., Gross R., and Feldman S.T. Intraocular pressure elevation associated with inhalation and nasal corticosteroids. Ophthalmology 102 (1995) 177-179
40. Cumming R.G., Mitchell P., and Leeder S.R. Use of inhaled corticosteroids and the risk of cataracts. N Engl J Med. 337 (1997) 8-14
41. Pick S.S., Vasilakis-Scaramozza C., and Maier W.C. The risk of cataract among users of inhaled steroids. Epidemiology 12 (2001) 229-234
42. Smeeth L., Boulis M., Hubbard R., and Fletcher A.E. A population based case-control study of cataract and inhaled corticosteroids. BrJOphthalmol 87 (2003) 1247-1251
43. Toogood J.H., Markov A.E., and Baskerville Dyson C. Association of ocular cataracts with inhaled and oral steroid therapy during long-term treatment ofasthma. J Allery Clin Immunol 91 (1993) 571-579
44. Simons F.E., Persaud M.P., Gillespie C.A., et al. Absence of posterior subcapsular cataracts in young patients treated with inhaled glucocorticoids. Lancet 342 (1993) 776-778
45. Autio P., Karjalainen J., Risteli L., et al. Effects of an inhaled steroid (budesonide) on skin collagen synthesis of asthma patients in vivo. Am J Respir Crit Care Med. 153 (1996) 1172-1175
46. Capewell S., Reynolds S., Shuttleworth D., et al. Purpura and dermal thinning associated with high dose inhaled corticosteroids. BMJ 300 (1990) 1548-1551
47. Storms W.W., and Theen C. Clinical adverse effects of inhaled corticosteroids: Results of a questionnaire survey of asthma specialists. Ann Allergy Asthma Immunol 80 (1998) 391-394
48. Lipworth B.J., and Jackson C.M. Safety of inhaled and intranasal corticosteroids: Lessons for the new millennium. Drug Saf 23 (2000) 11-33
49. discussion 51-52. Edsbacker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 58 Suppl 4 (1999) 7-16
50. Rohatagi S., Bye A., Falcoz C., et al. Dynamic modeling of cortisol reduction after inhaled administration of fluticasone propionate. J Clin Pharmacol. 36 (1996) 938-941
51. Mackie A.E., McDowall J.E., Ventresca P., et al. Systemic exposure to fluticasone propionate administered via metered-dose inhaler containing chlorofluorocarbon or hydrofluoroalkane propellant. Clin Pharmacokinet. 39 Suppl 1 (2000) 17-22
52. Lyttle B., Gilles J., Panov M., et al. Fluticasone propionate 100 microg bid using a non-CFC propellant, HFA 134a, in asthmatic children. Can Respir J. 10 (2003) 103-109
53. Asmus M.J., Liang J., Coowanitwong I., et al. In vitro deposition of fluticasone aerosol from a metered-dose inhaler with and without two common valved holding chambers. Ann Allergy Asthma Immunol. 88 (2002) 204-208
54. Cripps A., Riebe M., Schulze M., and Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 94 Suppl B (2000) S3-S9
55. Leach C.L., Davidson P.J., Hasselquist B.E., and Boudreau R.J. Lung deposition of hydrofluoroalkane-134a beclo methasone is greater than that of chlorofluorocarbon fluticasone and chlorofluorocarbonbeclomethasone: A cross-over study in healthy volunteers. Chest 122 (2002) 510-516
56. Abstract. Kaliner M., Rohatagi S., Zech K., and Banerji D. The receptor binding of ciclesonide: Comparison to other inhaled corticosteroids. Ann Allergy Asthma Immunol. 90 (2003) 129-130
57. Abstract. Rohatagi S., Derendorf H., Zech K., et al. PK/PD of inhaled corticosteroids: The risk/benefit of ciclesonide. J Allergy Clin Immunol 111 (2003) A598
58. Leach CL, Bethke TD, Boudreau RJ,et al.2-D and 3-D imaging show ciclesonide has high lung deposition and peripheral distribution: A nonrandomized study in healthy volunteers. J Aerosol Med. In press.
59. Rohatagi S., Luo Y., Shen L., et al. Protein binding and its potential for eliciting minimal systemic side effects with a novel inhaled corticosteroid, ciclesonide. Am J Ther. 12 (2005) 201-209
60. Nave R., Bethke T.D., van Marle S.P., and Zech K. Pharmacokinetics of [14C] ciclesonide after oral and intravenous administration to healthy subjects. Clin Pharmacokinet. 43 (2004) 479-486
61. Abstract. Miller-Larsson A., Axelsson B.O., Brattsand R., et al. Relative lipophilicity of budesonide, fluticasone propionate, mometasone furoate, and ciclesonide. Prevalence of variable lipophilicity in airways versus systemic compartments. Am J RespirCrit Care Med. 167 (2003) A773
62. [package insert]. Flovent (2003), GlaxoSmithKline, Research Triangle Park, NC
63. NIH publication 02-5075. National Asthma Education and Prevention Program. Expert Panel Report II. Guidelines for the Diagnosis and Management of Asthma-Update on Selected Topics, 2002 (2002), National Institutes of Health, Bethesda, Md
64. Lipworth B.J. Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta analysis. Arch Intern Med. 159 (1999) 941-955
65. Szefler S.J., Martin R.J., King T.S., et al., Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol. 109 (2002) 410-418
66. Boorsma M., Andersson N., Larsson P., and Ullman A. Assessment of the relative systemic potency of inhaled flu ticasone and budesonide. Eur Respir J. 9 (1996) 1427-1432
67. Brus R. Effects of high-dose inhaled corticosteroids on plasma cortisol concentrations in healthy adults. Arch Intern Med. 159 (1999) 1903-1908
68. Casale T.B., Nelson H.S., Stricker W.E., et al. Suppression of hypothalamicpituitary-adrenal axis activity with inhaled flunisolide and fluticasone propionate in adult asthma patients. Ann Allergy Asthma Immunol. 87 (2001) 379-385
69. Clark D.J., and Lipworth B.J. Adrenal suppression with chronic dosing of fluticasone propionate compared with budesonide in adult asthmatic patients. Thorax 52 (1997) 55-58
70. Fowler S.J., Orr L.C., Wilson A.M., et al. Dose-response for adrenal suppression with hydrofluoroalkane formulations of fluticasone propionate and beclomethasone dipropionate. Br J Clin Pharmacol. 52 (2001) 93-95
71. Fowler S.J., Orr L.C., Sims E.J., et al. Therapeutic ratio of hydrofluoroalkane and chlorofluorocarbon formulations of fluticasone propionate. Chest 122 (2002) 618-623
72. Martin R.J., Szefler S.J., Chinchilli V.M., et al. Systemic effect comparisons of six inhaled corticosteroid preparations. Am J Respir Crit Care Med. 165 (2002) 1377-1383
73. Jarvis B., and Faulds D. Inhaled fluticasone propionate: A review of its therapeutic efficacy at dosages < or = 500 microg/day in adults and adolescents with mild to moderate asthma. Drugs 57 (1999) 769-803
74. Chervinsky P., van As A., Bronsky E.A., et al., Fluticasone Propionate Asthma Study Group. Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. J Allergy Clin Immunol 94 (1994) 676-683
75. Weiner P., Berar-Yanay N., Davidovich A., and Magadle R. Nocturnal cortisol secretion in asthmatic patients after inhalation of fluticasone propionate. Chest 116 (1999) 931-934
76. White M, Crisalida T, Li H, et al. Effects of long term inhaled corticosteroids on adrenal function in asthmatics. Ann Allergy Asthma Immunol. In press.
77. Wong J., Davies T., and O'Callaghan C. Estimation of the dose of fluticasone propionate inhaled by infants after bronchiolitis: Effect on urinary cortisol excretion. J Allergy Clin Immunol 110 (2002) 721-727
78. Eid N., Morton R., Olds B., et al. Decreased morning serum cortisol levels in children with asthma treated with inhaled fluticasone propionate. Pediatrics 109 (2002) 217-221
79. Kannisto S., Korppi M., Arikoski P., et al. Biochemical markers of bone metabolism in relation to adrenocortical and growth suppression during the initiation phase of inhaled steroid therapy. Pediatr Res 52 (2002) 258-262
80. Wong J.Y., Zacharin M.R., Hocking N., and Robinson P.J. Growth and adrenal suppression in asthmatic children on moderate to high doses offluticasone propionate. J Paediatr Child Health 38 (2002) 59-62
81. Griffiths A.L., Sim D., Strauss B., et al. Effect of high-dose fluticasone propionate on bone density and metab olism in children with asthma. Pediatr Pulmonol 37 (2004) 116-121
82. De Swert L.F., Wouters C., and de Zegher F. Myopathy in children receiving highdose inhaled fluticasone. N Engl J Med. 350 (2004) 1157-1159
83. Abstract. Bundschuh D.S., Riedel R., Hatzelmann A., et al. Efficacy and safety profile of the novel on-site activated corticosteroid ciclesonide. Am J Respir Crit Care Med 163 (2001) A588
84. Nave R, Fisher R, Zech K. In vitro metabolism of ciclesonide in the human lung and liver precision-cut tissue slices. Biopharm Drug Dispos. In press.
85. Rohatagi S., Arya V., Zech K., et al. Population pharmacokinetics and pharmacodynamics of ciclesonide. J Clin Pharmacol 43 (2003) 365-378
86. Vanden Burgt J.A., Busse W.W., Martin R.J., et al. Efficacy and safety overview of new inhaled cortico steroid, QVAR (hydrofluoroalkanebeclomethasone extrafine inhalation aerosol), in asthma. J Allergy Clin lmmunol 106 (2000) 1209-1226
87. Richter K., Kanniess F., Biberger C., et al. Comparison of the oropharyngeal deposition of inhaled ciclesonide and fluticasone propionate in patients with asthma. J Gin Pharmacol. 45 (2005) 146-152
88. Abstract. Banerji D., Szwarcberg J., Fish J., et al. Ciclesonide and placebo have similar incidence of oropharyngeal ad verse events in adolescent/adult and pediatric asthma patients: Results frompooled analyses. Allergy Asthma Proc. 25 (2004) P206
89. Pearlman D.S., Berger W.E., Kerwin E., et al. Once-daily ciclesonide improves lung function and is well tolerated by patients with mild-to-moderate persistent asthma. J Allergy Clin Immunol. 116 (2005) 1206-1212
90. Abstract. Bernstein J.A., Noonan M.J., Rim C., et al. Ciclesonide has minimal oropharyngeal side effects in the treatment of patients with moderate-to-severe asthma. J Allergy Clin Immunol 113 Suppl 2 (2004) A349
91. Lipworth B.J., Kaliner M.A., LaForce C.F., et al. Effect of ciclesonide and fluticasone on hypothalamic-pituitaryadrenal axis function in adults with mild-to-moderate persistent asthma. Ann Allergy Asthma Immunol 94 (2005) 465-472
92. Chapman K.R., Patel P., D'Urzo A.D., et al. Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy 60 (2005) 330-337
93. Nave R., Meyer W., Fuhst R., and Zech K. Formation of fatty acid conjugates of ciclesonide active metabolite in the rat lung after 4-week inhalation of ciclesonide. Pulm Pharmacol Ther. 18 (2005) 390-396
94. Peet C.F., Enos T., Nave R., et al. Identification of enzymes involved in phase I metabolism of ciclesonide by human liver microsomes. Eur J Drug Metab Pharmacokinet 30 (2005) 275-286
95. Postma D.S., Sevette C., Martinat Y., et al. Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening. Eur Respir J. 17 (2001) 1083-1088
96. Abstract. Chapman K.R., Patel P., Boulet L.P., et al. Efficacy and long-term safety of ciclesonide in asthmatic patients as demonstrated in a 52 week long study. Eur Respir J. 20 Suppl 38 (2002) S373
97. Derom E., Van De Velde V., Marissens S., et al. Effects of inhaled ciclesonide and fluticasone propionate on cortisol secretion and airway responsiveness to adenosine 5′ monophosphate in asthmatic patients. Pulm Pharmacol Ther. 18 (2005) 328-336
98. Szefler S., Rohatagi S., Williams J., et al. Ciclesonide, a novel inhaled steroid, does not affect hypothalamic pituitary-ad renal axis functionin patients with moderate-to-severe persistentasthma. Chest 128 (2005) 104-1114
99. Weinbrenner A., Huneke D., Zschiesche M., et al. Circadian rhythm of serum cortisol after repeated inhalation of the new topical steroid ciclesonide. J Clin Endocrinol Metab. 87 (2002) 2160-2163
100. Abstract. O'Connor B., Sips P., Engelstatter R., et al. Management of moderate to severe bronchial asthma by cicle sonide: A 12-week trial. Am J Respir Crit Care Med. 165 (2002) A767
101. Abstract. O'Connor B.J., Kilfeather S., Cheung D., et al. Treatment of moderate to severe asthma with ciclesonide: A long-term investigation over 52 weeks. Eur Respir J. 20 Suppl 38 (2002) S406