Fluticasone propionate/salmeterol for the treatment of chronic-obstructive pulmonary disease

Chronic-obstructive pulmonary disease (COPD) is a global public health problem and its impact is increasing. Although only smoking cessation has been shown to alter the natural history of the disease, current treatment guidelines recommend the use of inhaled bronchodilators to decrease symptoms, improve lung function and quality of life and to prevent exacerbations. For a subset of patients with more severe disease, inhaled corticosteroids may also have a role in achieving these goals. Fluticasone propionate/salmeterol (Advair® or Seretide®, GlaxoSmithKline) is a combination inhaled steroid and long-acting bronchodilator that is delivered by a dry-powder inhaler and was recently approved for use in COPD in the US. Fluticasone propionate/salmeterol is a potent bronchodilator and also appears to have important effects on the frequency of exacerbations and overall quality of life for some patients with COPD. Issues of patient selection as well as the pharmacology, efficacy and safety of the drug are discussed.

[1]  V. Brusasco,et al.  Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. , 2003, Thorax.

[2]  M. Cazzola,et al.  Salmeterol/fluticasone propionate in a Single Inhaler Device versus theophylline+fluticasone propionate in patients with COPD. , 2004, Pulmonary pharmacology & therapeutics.

[3]  W. MacNee,et al.  Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper , 2004, European Respiratory Journal.

[4]  K. Weiss,et al.  Fracture risk associated with inhaled corticosteroid use in chronic obstructive pulmonary disease. , 2004, American journal of respiratory and critical care medicine.

[5]  S. Suissa,et al.  Inhaled and nasal corticosteroid use and the risk of fracture. , 2004, American journal of respiratory and critical care medicine.

[6]  B. Perera Salmeterol multicentre asthma research trial (SMART): interim analysis shows increased risk of asthma related deaths. , 2011, The Ceylon medical journal.

[7]  P. Barnes,et al.  An Atlas of Chronic Obstructive Pulmonary Disease , 2003 .

[8]  P. Calverley,et al.  Respiratory failure in chronic obstructive pulmonary disease , 2003, European Respiratory Journal.

[9]  N. Anthonisen,et al.  Contemporary management of chronic obstructive pulmonary disease: scientific review. , 2003, JAMA.

[10]  E. R. Sutherland,et al.  Inhaled corticosteroids reduce the progression of airflow limitation in chronic obstructive pulmonary disease: a meta-analysis , 2003, Thorax.

[11]  N. Hanania,et al.  The Efficacy and Safety of Fluticasone Propionate (250 μg)/Salmeterol (50 μg) Combined in the Diskus Inhaler for the Treatment of COPD , 2003 .

[12]  J. Walters,et al.  Adverse Effects of β-Agonists , 2003 .

[13]  R. Buhl Budesonide/formoterol for the treatment of asthma , 2003, Expert opinion on pharmacotherapy.

[14]  S. Spencer,et al.  Bronchodilator reversibility testing in chronic obstructive pulmonary disease , 2003, Thorax.

[15]  I. Stiell,et al.  Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. , 2003, The New England journal of medicine.

[16]  C. Funck-Brentano,et al.  Cardiovascular safety of salmeterol in COPD. , 2003, Chest.

[17]  R. Hubbard,et al.  A population based case-control study of cataract and inhaled corticosteroids , 2003, The British journal of ophthalmology.

[18]  R. Pauwels,et al.  Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial , 2003, The Lancet.

[19]  R. Sansores,et al.  Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease , 2003, European Respiratory Journal.

[20]  K. Weiss,et al.  The Association Between Inhaled Corticosteroid Use and Fractures in Veterans With Chronic Obstructive Pulmonary Diseas , 2003 .

[21]  D. Clark,et al.  Inhaled Corticosteroid Use and Risk of Non-vertebral Fracture Among Adults With Chronic Obstructive Lung Disease in UK General Practice , 2003 .

[22]  J. Donohue,et al.  Fluticasone/Salmeterol Combination (250/50) Provides Greater Improvement in Lung Function and Symptoms Than the Combination of Ipratropium/Albuterol in Patients With COP , 2003 .

[23]  C. Johannes,et al.  The Risk of Non-vertebral Fracture Related to Inhaled Corticosteroid Exposure Among Adults With Physician-Diagnosed Respiratory Disease , 2003 .

[24]  J. Walters,et al.  Adverse effects of beta-agonists: are they clinically relevant? , 2003, American journal of respiratory medicine : drugs, devices, and other interventions.

[25]  J. van der Palen,et al.  Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. , 2002, American journal of respiratory and critical care medicine.

[26]  J. Yates,et al.  Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. , 2002, American journal of respiratory and critical care medicine.

[27]  N. Pride,et al.  Survival in COPD patients after regular use of fluticasone propionate and salmeterol in general practice , 2002, European Respiratory Journal.

[28]  D. Mannino,et al.  Chronic obstructive pulmonary disease surveillance--United States, 1971-2000. , 2002, Morbidity and mortality weekly report. Surveillance summaries.

[29]  H. Hoogsteden,et al.  Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness , 2002, Thorax.

[30]  Abdullah Alsaeedi,et al.  The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials. , 2002, The American journal of medicine.

[31]  E. Bateman,et al.  A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. , 2002, Chest.

[32]  O. Johnell,et al.  Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler® , 2002, European Respiratory Journal.

[33]  A. Sharafkhaneh,et al.  β-agonist intrinsic efficacy: Measurement and clinical significance , 2002 .

[34]  J. Curtis,et al.  Association between inhaled beta-agonists and the risk of unstable angina and myocardial infarction. , 2002, Chest.

[35]  M. Cazzola,et al.  Clinical Pharmacokinetics of Salmeterol , 2002, Clinical Pharmacokinetics.

[36]  P. Barnes,et al.  Scientific rationale for inhaled combination therapy with long-acting β2-agonists and corticosteroids , 2002, European Respiratory Journal.

[37]  A. Sharafkhaneh,et al.  Beta-agonist intrinsic efficacy: measurement and clinical significance. , 2002, American journal of respiratory and critical care medicine.

[38]  H. Möllmann,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 , 2001, Journal of clinical pharmacology.

[39]  C. Löfdahl,et al.  Pharmacokinetics and systemic activity of fluticasone via Diskus and pMDI, and of budesonide via Turbuhaler. , 2001, British journal of clinical pharmacology.

[40]  C. Sherman,et al.  Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. , 2001, American journal of respiratory and critical care medicine.

[41]  R. Pauwels,et al.  Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. , 2001, American journal of respiratory and critical care medicine.

[42]  G. Canonica,et al.  Inhaled triamcinolone and chronic obstructive pulmonary disease. , 2001, The New England journal of medicine.

[43]  L. Squassante,et al.  Salmeterol and fluticasone propionate given as a combination , 2001, European Journal of Clinical Pharmacology.

[44]  J. Connett,et al.  Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. , 2000, The New England journal of medicine.

[45]  M. Cazzola,et al.  Additive effects of salmeterol and fluticasone or theophylline in COPD. , 2000, Chest.

[46]  R. Hancox,et al.  Interactions between corticosteroids and β agonists , 2000 .

[47]  S. Spencer,et al.  Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial , 2000, BMJ : British Medical Journal.

[48]  P. Barnes,et al.  Mechanisms in COPD: differences from asthma. , 2000, Chest.

[49]  tefan,et al.  LONG-TERM TREATMENT WITH INHALED BUDESONIDE IN PERSONS WITH MILD CHRONIC OBSTRUCTIVE PULMONARY DISEASE WHO CONTINUE SMOKING , 2000 .

[50]  R. Hancox,et al.  Interactions between corticosteroids and beta agonists. , 2000, Thorax.

[51]  N. Jackson,et al.  Reversal of human neutrophil survival by leukotriene B(4) receptor blockade and 5-lipoxygenase and 5-lipoxygenase activating protein inhibitors. , 1999, American journal of respiratory and critical care medicine.

[52]  W. Maziak,et al.  Effect of high dose inhaled steroid on cells, cytokines, and proteases in induced sputum in chronic obstructive pulmonary disease. , 1999, American journal of respiratory and critical care medicine.

[53]  A. Adelman Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. , 1999, The Journal of family practice.

[54]  O. Kayacan,et al.  Formoterol and Salmeterol in Partially Reversible Chronic Obstructive Pulmonary Disease: A Crossover, Placebo-Controlled Comparison of Onset and Duration of Action , 1999, Respiration.

[55]  D. Niewoehner,et al.  Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. Department of Veterans Affairs Cooperative Study Group. , 1999, The New England journal of medicine.

[56]  D. Kellerman,et al.  Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma. , 1999, The Journal of allergy and clinical immunology.

[57]  P. Lange,et al.  Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial , 1999, The Lancet.

[58]  S. Yancey,et al.  Efficacy of salmeterol xinafoate in the treatment of COPD. , 1999, Chest.

[59]  A. Buchwald,et al.  Pharmacokinetic and pharmacodynamic aspects of salmeterol therapy. , 1998, International journal of clinical pharmacology and therapeutics.

[60]  S. Suissa,et al.  Association of inhaled corticosteroid use with cataract extraction in elderly patients. , 1998, JAMA.

[61]  J. Bourbeau,et al.  Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease. , 1998, Thorax.

[62]  P. Paggiaro,et al.  Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease , 1998, The Lancet.

[63]  M. Johnson,et al.  Effect of salmeterol on Haemophilus influenzae infection of respiratory mucosa in vitro. , 1998, The European respiratory journal.

[64]  J. Paulson,et al.  Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. , 2003, British journal of clinical pharmacology.

[65]  H. Möllmann,et al.  Pharmacokinetic/Pharmacodynamic Aspects of Aerosol Therapy using Glucocorticoids as a Model , 1997, Journal of clinical pharmacology.

[66]  R. Cumming,et al.  Use of inhaled corticosteroids and the risk of cataracts. , 1997, The New England journal of medicine.

[67]  A. Casalini,et al.  Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study. , 1997, American journal of respiratory and critical care medicine.

[68]  Alan D. Lopez,et al.  Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study , 1997, The Lancet.

[69]  Alan D. Lopez,et al.  Mortality by cause for eight regions of the world: Global Burden of Disease Study , 1997, The Lancet.

[70]  D. McDonald,et al.  Salmeterol reduces early- and late-phase plasma leakage and leukocyte adhesion in rat airways. , 1997, American journal of respiratory and critical care medicine.

[71]  G. Taylor,et al.  Effect of salmeterol on Pseudomonas aeruginosa infection of respiratory mucosa. , 1997, American journal of respiratory and critical care medicine.

[72]  A. Bye,et al.  Pharmacokinetics of intravenous fluticasone propionate in healthy subjects. , 2003, British journal of clinical pharmacology.

[73]  D. Griffith,et al.  Differential effects of salmeterol on lung endothelial and epithelial leakage in sheep. , 1996, Journal of applied physiology.

[74]  R. Stockley,et al.  Effect of fluticasone propionate on sputum of patients with chronic bronchitis and emphysema. , 1996, American journal of respiratory and critical care medicine.

[75]  W. Bailey,et al.  Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study. , 1995, JAMA.

[76]  W. Bailey,et al.  Effects of Smoking Intervention and the Use of an Inhaled Anticholinergic Bronchodilator on the Rate of Decline of FEV1 , 1994 .

[77]  M. Zureik,et al.  Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI. , 1994, The European respiratory journal.

[78]  P. Ind,et al.  Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid , 1994, The Lancet.

[79]  G. Taylor,et al.  Effect of salmeterol on human nasal epithelial cell ciliary beating: inhibition of the ciliotoxin, pyocyanin , 1994, British journal of pharmacology.

[80]  M. Cazzola,et al.  Effect of salmeterol and formoterol in patients with chronic obstructive pulmonary disease. , 1994, Pulmonary pharmacology.

[81]  Phillips Yy,et al.  Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD) and asthma. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, November 1986. , 1987, The American review of respiratory disease.