Relevant pharmacokinetic parameters for determining efficacy and safety in inhaled corticosteroids

European Respiratory Review

Volumn 13, Issue 90, 2004, Pages 62-65

  Derendorf, H ^a  

^a UNIVERSITY OF FLORIDA   (United States)

Author keywords

Corticosteroids; Inhalation; Pharmacodynamics; Pharmacokinetics; Pulmonary delivery

Indexed keywords

BECLOMETASONE DIPROPIONATE; BUDESONIDE; CICLESONIDE; CORTICOSTEROID; FLUNISOLIDE; FLUTICASONE PROPIONATE; MOMETASONE FUROATE; TRIAMCINOLONE ACETONIDE;

CONFERENCE PAPER; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; HUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; SIDE EFFECT;

EID: 3242674262     PISSN: 09059180     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (31)

1. Derendorf H, Hochhaus G, Meibohm B, Mollmann H, Barth J. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 1998; 101: Suppl. 4 Pt 2, 440-446.
2. Dietzel K, Engelstatter R, Keller A. Ciclesonide: an on-site-activated steroid. In: Hansel TT, Barnes PJ, ed. New drugs for asthma, allergy and COPD. Prog Respir Res. Basel, Karger, 2001; 31: pp. 91-93.
3. Daley-Yates PT, Price AC, Sisson JR, Pereira A, Dallow N. Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol 2001; 51: 400-409.
4. Nave R, Sättele N, Meyer W, Fuhst R, Zech K. Formation of fatty acid conjugates of ciclesonide-active principle in the rat lung after 4-week inhalation of ciclesonide. Am J Respir Crit Care Med 2003; 167: Suppl. 7, A771.
5. 14C-ciclesonide after oral and intravenous administration in healthy subjects. Eur Respir J 2002; 20: Suppl. 38, 109s.
6. Mollmann H, Wagner M, Krishnaswami S et al. Single-dose and steady-state pharmacokinetic and pharmacodynamic evaluation of therapeutically clinically equivalent doses of inhaled fluticasone propionate and budesonide, given as Diskus or Turbohaler dry-powder inhalers to healthy subjects. J Clin Pharmacol 2001; 41: 1329-1338.
7. Bethke TD, Boudreau RJ, Hasselquist BE et al. High lung deposition of ciclesonide in 2D- and 3D-imaging. Eur Respir J 2002; 20: Suppl. 38, 109s.
8. Nave R, Bethke TD, Zech K, et al. Phamacokinetic profiles of ciclesonide and its active metabolite are similar in asthma patients and healthy subjects. Presented at the 4th Triennial World Asthma Meeting 2004; Bangkok, Thailand.
9. Ryrfeldt A, Andersson P, Edsbacker S, Tonnesson M, Davies DE, Pauwels RA. Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur J Respir Dis 1982; 63: 86-95.
10. Dickens GR, Wermeling DP, Matheny CJ et al. Pharmacokinetics of flunisolide administered via metered dose inhaler with and without a spacer device and following oral administration. Ann Allergy Asthma Immunol 2000; 84: 528-532.
11. Thorsson L, Dahlstrom K, Edsbacker A, Kallen J, Paulson J, Wiren J-E. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1997; 43: 155-161.
12. Mollmann H, Wagner M, Meibohm B et al. Pharmacokinetic and pharmacodynamic evaluation of fluticasone propionate after inhaled administration. Eur J Clin Pharmacol 1998; 53: 459-467.
13. Nave R, Drollmann A, Bethke TD, Zech K, Steinijans VW. Repeated daily inhalations of ciclesonide, compared to single inhalation do not lead to increased systemic exposure. Eur Respir J 2003; 22: Suppl. 45, 282s
14. Affrime MB, Cuss F, Padhi D et al. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers. J Clin Pharmacol 2000; 40: 1227-1236.
15. Derendorf H, Daley-Yates PT, Pierre LN, Efthimiou J. Bioavailability and metabolism of mometasone furoate: pharmacology versus methodology. J Clin Pharmacol 2002; 42: 383-387.
16. Crim C, Pierre LN, Daley-Yates PT. A review of the pharmacology and pharmacokinetics of inhaled fluticasone propionate and mometasone furoate. Clin Ther 2001; 23: 1339-1354.
17. Rowland M, Tozer TN. Clinical Pharmacokinetics: Concepts and Applications. 3rd Edn. Philadelphia, Williams & Wilkins, 1995.
18. Mackie AE, Ventresca GP, Fuller RW, Bye A. Pharmacokinetics of intravenous fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1996; 41: 539-542.
19. Nave R, Fisher R, Zech K. In vitro metabolism of ciclesonide in the human lung and liver as determined by use of precision-cut tissue slices. Am J Respir Crit Care Med 2003; 165: Suppl. 7 Pt 2, A771.
20. Nave R, Bethke TD, Seiberling M, Steinijans VW, Zech K. Pharmacokinetics and pharmacodynamics of ciclesonide and its active principle after inhalative and intravenous administration in healthy subjects. Eur Respir J 2002; 20: Suppl. 38, 110s.
21. Miller-Larsson A, Mattsson H, Hjertberg E, Dahlback M, Tunek A, Brattsand R. Reversible fatty acid conjugation of budesonide. Novel mechanism for prolonged retention of topically applied steroid in airway tissue. Drug Metab Dispos 1998; 26: 623-630.
22. Tunek A, Sjodin K, Hallstrom G. Reversible formation of fatty acid esters of budesonide, an antiasthma glucocorticoid, in human lung and liver microsomes. Drug Metab Dispos 1997; 25: 1311-1317.
23. Nave R, Hummel R-P, Wohlsen A, et al. The active metabolite of ciclesonide, des-isobutyryl ciclesonide, forms highly lipophilic fatty acid conjugates in precision-cut rat lung slices. Am J Respir Crit Care Med 2004; 169: Suppl. 7, A91.
24. Engelstatter R, Langdon C, Bethke T, Rathgeb F, VW Steinijans, Wurst W. Efficacy of ciclesonide after twelve-week treatment of bronchial asthma. Am J Respir Crit Care Med 2002; 165: Suppl. 8 Pt 2, D37.
25. Chapman KR, D'Urzo AD, Oedekoven C, Steinijans VW, Wurst W. Effects of ciclesonide versus placebo on lung function after 12 weeks of treatment in patients with asthma. Am J Respir Crit Care Med 2002; 165: Suppl. 8 Pt 2, D37.
26. Biberger C, von Behren V, Malek R, et al. Efficacy and safety of ciclesonide compared with budesonide in asthma patients: a randomised 12-week study. Am J Respir Crit Care Med 2003; 165: Suppl. 7 Pt 2, A771.
27. Szefler SJ. Pharmacokinetics of intranasal corticosteroids. J Allergy Clin Immunol 200 1; 108: Suppl. 1, S26-31.
28. Kelly HW. Comparative potency and clinical efficacy of inhaled corticosteroids. Respir Care Clin N Am 1999; 5: 537-553.
29. Rohatagi S, Derendorf H, Zech K, Nave R, Banerji D. PK/PD of inhaled corticosteroids: the risk/benefit of inhaled ciclesonide. J Allergy Clin Immunol 2003; 111: Suppl. 2, S218.
30. Nave R, Zech K, Bethke TD. Oropharyngeal deposition of inhaled ciclesonide and budesonide in healthy subjects. J Allergy Clin Immunol 2003; 111: Suppl. 2, S220.
31. Richter K, Nielsen-Gode D, Biberger C, Nave R, Magnussen H. Oropharyngeal deposition of inhaled ciclesonide and fluticasone propionate in asthmatics. Am J Respir Crit Care Med 2002; 165: Suppl. 8 Pt 2, A59.