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Erschienen in: Drugs 11/2009

01.07.2009 | Adis Drug Profile

Budesonide/Formoterol Pressurized Metered-Dose Inhaler

In Chronic Obstructive Pulmonary Disease

verfasst von: Katherine A. Lyseng-Williamson

Erschienen in: Drugs | Ausgabe 11/2009

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Abstract

  • ▲ The corticosteroid budesonide and the rapid-onset, long-acting β2-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for use in patients with chronic obstructive pulmonary disease (COPD).
  • ▲ Well designed 6- and 12-month clinical trials, twice-daily budesonide/formoterol pMDI 320μg/9μg effectively improved lung function in patients with moderate to very severe COPD.
  • ▲ The co-primary endpoints of adjusted mean morning predose forced expiratory volume in 1 second (FEV1) and 1-hour post-dose FEV1 improved from baseline to a significantly greater extent with twice-daily budesonide/formoterol pMDI 320μg/9μg than with twice-daily placebo, budesonide pMDI 320 µg and formoterol dry powder inhaler 9 μg.
  • ▲ Budesonide/formoterol pMDI was also associated with improvements from baseline in other measures of lung function, COPD control (including the time to first COPD exacerbation in the 12-month trial), symptoms and health status. These improvements were significantly greater than those observed with placebo and, for some endpoints, monotherapy with the individual components.
  • ▲ Budesonide/formoterol pMDI was well tolerated in clinical trials in patients with COPD. Its overall adverse event profile is consistent with the known tolerability profiles of formoterol and budesonide, and is generally similar to that with placebo.
Literatur
1.
Zurück zum Zitat Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (updated 2008) [online]. Available from URL: http://www.goldcopd.com [Accessed 2009 Apr 21] Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (updated 2008) [online]. Available from URL: http://​www.​goldcopd.​com [Accessed 2009 Apr 21]
2.
Zurück zum Zitat Morbidity and mortality: 2007 chart book on cardiovascular, lung, and blood diseases. Bethesda (MD): National Heart, Lung, and Blood Institute, 2007 Morbidity and mortality: 2007 chart book on cardiovascular, lung, and blood diseases. Bethesda (MD): National Heart, Lung, and Blood Institute, 2007
3.
Zurück zum Zitat Wise RA, Tashkin DP. Optimizing treatment of chronic obstructive pulmonary disease: an assessment of current therapies. Am J Med 2007 Aug; 120 (8 Suppl. 1): S4–13PubMedCrossRef Wise RA, Tashkin DP. Optimizing treatment of chronic obstructive pulmonary disease: an assessment of current therapies. Am J Med 2007 Aug; 120 (8 Suppl. 1): S4–13PubMedCrossRef
4.
Zurück zum Zitat Rodrigo GJ, Nannini LJ, Rodríguez-Roisin R. Safety of long-acting β-agonists in stable COPD: a systematic review. Chest 2008 May; 133(5): 1079–87PubMedCrossRef Rodrigo GJ, Nannini LJ, Rodríguez-Roisin R. Safety of long-acting β-agonists in stable COPD: a systematic review. Chest 2008 May; 133(5): 1079–87PubMedCrossRef
5.
Zurück zum Zitat Drummond MB, Dasenbrook EC, Pitz MW, et al. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008 Nov 26; 300(20): 2407–16PubMedCrossRef Drummond MB, Dasenbrook EC, Pitz MW, et al. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008 Nov 26; 300(20): 2407–16PubMedCrossRef
6.
Zurück zum Zitat Yang IA, Fong KM, Sim EH, et al. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Apr 18; (2): CD002991 Yang IA, Fong KM, Sim EH, et al. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Apr 18; (2): CD002991
7.
Zurück zum Zitat Paul Man S, Sin DD. Inhaled corticosteroids in chronic obstructive pulmonary disease: is there a clinical benefit? Drugs 2005; 65(5): 579–91CrossRef Paul Man S, Sin DD. Inhaled corticosteroids in chronic obstructive pulmonary disease: is there a clinical benefit? Drugs 2005; 65(5): 579–91CrossRef
8.
Zurück zum Zitat Nannini LJ, Cates CJ, Lasserson TJ, et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus long-acting beta-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Oct 17; (4): CD006829 Nannini LJ, Cates CJ, Lasserson TJ, et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus long-acting beta-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Oct 17; (4): CD006829
9.
Zurück zum Zitat Nannini LJ, Cates CJ, Lasserson TJ, et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus inhaled steroids for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Oct 17; (4): CD006826 Nannini LJ, Cates CJ, Lasserson TJ, et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus inhaled steroids for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007 Oct 17; (4): CD006826
10.
Zurück zum Zitat Eklund A, Tronde A, Johannes-Hellberg I, et al. Pharmacokinetics of budesonide and formoterol administered via a series of single-drug and combination inhalers: four open-label, randomized, crossover studies in healthy adults. Biopharm Drug Dispos 2008 Oct; 29(7): 382–95PubMedCrossRef Eklund A, Tronde A, Johannes-Hellberg I, et al. Pharmacokinetics of budesonide and formoterol administered via a series of single-drug and combination inhalers: four open-label, randomized, crossover studies in healthy adults. Biopharm Drug Dispos 2008 Oct; 29(7): 382–95PubMedCrossRef
11.
Zurück zum Zitat Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol: US prescribing information. Wilmington (DE): AstraZeneca LP, 2009 Feb Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol: US prescribing information. Wilmington (DE): AstraZeneca LP, 2009 Feb
12.
Zurück zum Zitat Lyseng-Williamson KA, Simpson D. Budesonide/ formoterol pressurized metered-dose inhaler. Drugs 2008; 68(13): 1855–64PubMedCrossRef Lyseng-Williamson KA, Simpson D. Budesonide/ formoterol pressurized metered-dose inhaler. Drugs 2008; 68(13): 1855–64PubMedCrossRef
13.
Zurück zum Zitat Lindberg A, Szalai Z, Pullerits T, et al. Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. Respirology 2007; 12(5): 732–9PubMedCrossRef Lindberg A, Szalai Z, Pullerits T, et al. Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. Respirology 2007; 12(5): 732–9PubMedCrossRef
14.
Zurück zum Zitat Tashkin DP, Rennard SI, Martin P, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs 2008; 68(14): 1975–2000PubMedCrossRef Tashkin DP, Rennard SI, Martin P, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs 2008; 68(14): 1975–2000PubMedCrossRef
15.
Zurück zum Zitat Rennard SI, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease. Drugs 2009; 69(5): 549–65PubMedCrossRef Rennard SI, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease. Drugs 2009; 69(5): 549–65PubMedCrossRef
16.
Zurück zum Zitat Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting β2-agonists and corticosteroids. Eur Resp J 2002 Jan; 19(1): 182–91CrossRef Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting β2-agonists and corticosteroids. Eur Resp J 2002 Jan; 19(1): 182–91CrossRef
17.
Zurück zum Zitat Szefler SJ. Pharmacodynamics and pharmacokinetics of budesonide: a new nebulized corticosteroid. J Allergy Clin Immunol 1999 Oct; 104 (4 Pt 2): S175–83CrossRef Szefler SJ. Pharmacodynamics and pharmacokinetics of budesonide: a new nebulized corticosteroid. J Allergy Clin Immunol 1999 Oct; 104 (4 Pt 2): S175–83CrossRef
18.
Zurück zum Zitat Faulds D, Hollingshead LM, Goa KL. Formoterol: a review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs 1991 Jul; 42(1): 115–37PubMedCrossRef Faulds D, Hollingshead LM, Goa KL. Formoterol: a review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs 1991 Jul; 42(1): 115–37PubMedCrossRef
19.
Zurück zum Zitat Reynolds NA, Perry CM, Keating GM. Budesonide/ formoterol in chronic obstructive pulmonary disease. Drugs 2004; 64(4): 431–41PubMedCrossRef Reynolds NA, Perry CM, Keating GM. Budesonide/ formoterol in chronic obstructive pulmonary disease. Drugs 2004; 64(4): 431–41PubMedCrossRef
20.
Zurück zum Zitat Lal H, Jansson AH, Falk-Hakansson H, et al. Intratracheal administration of combined budesonide and formoterol attenuates inflammation markers in a rat acute LPS model [abstract]. Am J Respir Crit Care Med 2008 Apr; 177 (Abstr. Suppl.): A105 Lal H, Jansson AH, Falk-Hakansson H, et al. Intratracheal administration of combined budesonide and formoterol attenuates inflammation markers in a rat acute LPS model [abstract]. Am J Respir Crit Care Med 2008 Apr; 177 (Abstr. Suppl.): A105
21.
Zurück zum Zitat Sovani MP, Whale CI, Tattersfield AE. A benefit-risk assessment of inhaled long-acting β2-agonists in the management of obstructive pulmonary disease. Drug Saf 2004; 27(10): 689–715PubMedCrossRef Sovani MP, Whale CI, Tattersfield AE. A benefit-risk assessment of inhaled long-acting β2-agonists in the management of obstructive pulmonary disease. Drug Saf 2004; 27(10): 689–715PubMedCrossRef
22.
Zurück zum Zitat Bonay M, Bancal C, Crestani B. Benefits and risks of inhaled corticosteroids in chronic obstructive pulmonary disease. Drug Saf 2002; 25(1): 57–71PubMedCrossRef Bonay M, Bancal C, Crestani B. Benefits and risks of inhaled corticosteroids in chronic obstructive pulmonary disease. Drug Saf 2002; 25(1): 57–71PubMedCrossRef
23.
Zurück zum Zitat Tronde A, Gillen M, Borgstrom L, et al. Pharmacokinetics of budesonide and formoterol administered via 1 pressurized metered-dose inhaler in patients with asthma and COPD. J Clin Pharmacol 2008 Nov; 48(11): 1300–8PubMedCrossRef Tronde A, Gillen M, Borgstrom L, et al. Pharmacokinetics of budesonide and formoterol administered via 1 pressurized metered-dose inhaler in patients with asthma and COPD. J Clin Pharmacol 2008 Nov; 48(11): 1300–8PubMedCrossRef
24.
Zurück zum Zitat Singh S, Amin AV, Loke YK. Long-term use of inhaled corticosteroids and the risk of pneumonia in chronic obstructive pulmonary disease: a meta-analysis. Arch Intern Med 2009 Feb 9; 169(3): 219–29PubMedCrossRef Singh S, Amin AV, Loke YK. Long-term use of inhaled corticosteroids and the risk of pneumonia in chronic obstructive pulmonary disease: a meta-analysis. Arch Intern Med 2009 Feb 9; 169(3): 219–29PubMedCrossRef
Metadaten
Titel
Budesonide/Formoterol Pressurized Metered-Dose Inhaler
In Chronic Obstructive Pulmonary Disease
verfasst von
Katherine A. Lyseng-Williamson
Publikationsdatum
01.07.2009
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 11/2009
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200969110-00005

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