Evaluating fluticasone furoate + vilanterol for the treatment of chronic obstructive pulmonary disease (COPD)

References

• Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990–2020: global burden of disease study. Lancet. 1997 May 24;349(9064):1498–1504. PubMed PMID: 9167458. .
   PubMed Web of Science ®Google Scholar
• Rabe KF, Hurd S, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532–555. PubMed PMID: 17507545.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Karpel JP, Clerisme-Beaty E, et al. Efficacy and safety of tiotropium + olodaterol maintenance treatment in patients with COPD in the TONADO((R)) and OTEMTO((R)) studies: a subgroup analysis by age. Int J Chron Obstruct Pulmon Dis. 2016;11:2701–2710. PubMed PMID: 27843306; PubMed Central PMCID: PMCPMC5098524.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Karpel J, Bennett N, et al. Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies. NPJ Prim Care Respir Med. 2017 Feb 2;27(1):7. PubMed PMID: 28154373; PubMed Central PMCID: PMCPMC5434778.
   PubMedGoogle Scholar
• Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2019.
   Google Scholar
• Mirza S, Clay RD, Koslow MA, et al. COPD guidelines: A review of the 2018 GOLD report. Mayo Clin Proc. 2018 Oct;93(10):1488–1502. PubMed PMID: 30286833.
   PubMed Web of Science ®Google Scholar
• Coleman CI, Limone B, Sobieraj DM, et al. Dosing frequency and medication adherence in chronic disease. J Manag Care Pharm. 2012 Sep;18(7):527–539. PubMed PMID: 22971206.
   PubMed Web of Science ®Google Scholar
• Procopiou PA, Barrett VJ, Bevan NJ, et al. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem. 2010 Jun 10;53(11):4522–4530. PubMed PMID: 20462258.
   PubMed Web of Science ®Google Scholar
• Lotvall J, Bakke PS, Bjermer L, et al. Efficacy and safety of 4 weeks‘ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. BMJ Open. 2012;2(1):e000370. PubMed PMID: 22267687; PubMed Central PMCID: PMCPMC3263438.
   PubMed Web of Science ®Google Scholar
• AJ HS F, Morrison V, Barrett VJ, et al. In vitro and in vivo pharmacological characterisation of GW642444, a novel long-acting β2 agonist (LABA), with fast onset and long duration in the guinea-pig [abstract]. Am J Respir Crit Care Med. 2010a;181:A5677.
   Web of Science ®Google Scholar
• Barrett VJMV, Sturton RG, Ford AJ, et al. Pharmacological characterisation of GW642444, a long-acting β2-agonist (LABA) with rapid onset and long duration, on isolated large and small human airways [abstract]. Am J Respir Crit Care Med. 2010b;181:A4453.
   Web of Science ®Google Scholar
• Harrell AW, Siederer SK, Bal J, et al. Metabolism and disposition of vilanterol, a long-acting beta(2)-adrenoceptor agonist for inhalation use in humans. Drug Metab Dispos. 2013 Jan;41(1):89–100. PubMed PMID: 23043183.
   PubMed Web of Science ®Google Scholar
• Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256–264. PubMed PMID: 23232038. .
   PubMed Web of Science ®Google Scholar
• Calzetta L, Rinaldi B, Cazzola M, et al. Pharmacodynamic and pharmacokinetic assessment of fluticasone furoate + vilanterol for the treatment of asthma. Expert Opin Drug Metab Toxicol. 2016 Jul;12(7):813–822. PubMed PMID: 27253498.
   PubMed Web of Science ®Google Scholar
• Biggadike K. Fluticasone furoate/fluticasone propionate – different drugs with different properties. Clin Respir J. 2011 Jul;5(3):183–184. PubMed PMID: 21569222; PubMed Central PMCID: PMCPMC3147057. .
   PubMed Web of Science ®Google Scholar
• Rossios C, To Y, To M, et al. Long-acting fluticasone furoate has a superior pharmacological profile to fluticasone propionate in human respiratory cells. Eur J Pharmacol. 2011 Nov 16;670(1):244–251. PubMed PMID: 21920359.
   PubMed Web of Science ®Google Scholar
• Hughes SC, Shardlow PC, Hollis FJ, et al. Metabolism and disposition of fluticasone furoate, an enhanced-affinity glucocorticoid, in humans. Drug Metab Dispos. 2008 Nov;36(11):2337–2344. PubMed PMID: 18694910.
   PubMed Web of Science ®Google Scholar
• Allen A, Bareille PJ, Rousell VM. Fluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionate. Clin Pharmacokinet. 2013 Jan;52(1):37–42. PubMed PMID: 23184737; PubMed Central PMCID: PMCPMC3693428. .
   PubMed Web of Science ®Google Scholar
• Thorsson L, Edsbacker S, Kallen A, et al. Pharmacokinetics and systemic activity of fluticasone via Diskus and pMDI, and of budesonide via Turbuhaler. Br J Clin Pharmacol. 2001 Nov;52(5):529–538. PubMed PMID: 11736861; PubMed Central PMCID: PMCPMC2014609.
   PubMed Web of Science ®Google Scholar
• Wang YB, Watts AB, Peters JI, et al. The impact of pulmonary diseases on the fate of inhaled medicines–a review. Int J Pharm. 2014 Jan 30;461(1–2):112–128. PubMed PMID: 24291124.
   PubMed Web of Science ®Google Scholar
• Allen A, Schenkenberger I, Trivedi R, et al. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study. Clin Respir J. 2013 Oct;7(4):397–406. PubMed PMID: 23578031; PubMed Central PMCID: PMCPMC4352333.
   PubMed Web of Science ®Google Scholar
• Covelli H, Pek B, Schenkenberger I, et al. Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk. Int J Chron Obstruct Pulmon Dis. 2016;11:1–12. PubMed PMID: 26730183; PubMed Central PMCID: PMCPMC4694692.
   PubMed Web of Science ®Google Scholar
• Boscia JA, Pudi KK, Zvarich MT, et al. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012 Aug;34(8):1655–66 e5. PubMed PMID: 22789766.
   PubMed Web of Science ®Google Scholar
• Kempsford R, Allen A, Kelly K, et al. A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects. Br J Clin Pharmacol. 2014 Mar;77(3):466–479. PubMed PMID: 24093504; PubMed Central PMCID: PMCPMC3952721.
   PubMed Web of Science ®Google Scholar
• [cited 2019 Mar 15]. https://gskpro.com/en-mt/products/relvar-ellipta/dosing-administration/.
   Google Scholar
• Kempsford R, Allen A, Bal J, et al. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects. Br J Clin Pharmacol. 2013 Jun;75(6):1478–1487. PubMed PMID: 23116485; PubMed Central PMCID: PMCPMC3690106.
   PubMed Web of Science ®Google Scholar
• Allen A, Davis A, Hardes K, et al. Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combination. Clin Ther. 2012 Dec;34(12):2316–2332. PubMed PMID: 23200625.
   PubMed Web of Science ®Google Scholar
• Allen A, Bal J, Cheesbrough A, et al. Pharmacokinetics and pharmacodynamics of intravenous and inhaled fluticasone furoate in healthy Caucasian and East Asian subjects. Br J Clin Pharmacol. 2014 May;77(5):808–820. PubMed PMID: 24152086; PubMed Central PMCID: PMCPMC4004401.
   PubMed Web of Science ®Google Scholar
• Yun Kirby S, Zhu CQ, Kerwin EM, et al. A preference study of two placebo dry powder inhalers in adults with COPD: ELLIPTA(R) dry powder inhaler (DPI) versus DISKUS(R) DPI. Copd. 2016;13(2):167–175. PubMed PMID: 26516724.
   PubMedGoogle Scholar
• Kerwin EM, Scott-Wilson C, Sanford L, et al. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respir Med. 2013 Apr;107(4):560–569. PubMed PMID: 23352226.
   PubMed Web of Science ®Google Scholar
• Martinez FJ, Boscia J, Feldman G, et al. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial. Respir Med. 2013 Apr;107(4):550–559. PubMed PMID: 23332861.
   PubMed Web of Science ®Google Scholar
• Dransfield MT, Feldman G, Korenblat P, et al. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171–1179. PubMed PMID: 24998880.
   PubMed Web of Science ®Google Scholar
• Agusti A, de Teresa L, De Backer W, et al. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763–772. PubMed PMID: 24114969.
   PubMed Web of Science ®Google Scholar
• Vestbo J, Leather D, Diar Bakerly N, et al. Effectiveness of fluticasone furoate-vilanterol for COPD in clinical practice. N Engl J Med. 2016 Sep 29;375(13):1253–1260. PubMed PMID: 27593504.
   PubMed Web of Science ®Google Scholar
• Martinez FJ, Vestbo J, Anderson JA, et al. Effect of fluticasone furoate and vilanterol on exacerbations of chronic obstructive pulmonary disease in patients with moderate airflow obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881–888. PubMed PMID: 27767328.
   PubMed Web of Science ®Google Scholar
• Kardos P, Wencker M, Glaab T, et al. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 Jan 15;175(2):144–149. PubMed PMID: 17053207.
   PubMed Web of Science ®Google Scholar
• Vestbo J, Anderson JA, Brook RD, et al. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817–1826. PubMed PMID: 27203508.
   PubMed Web of Science ®Google Scholar
• Crim C, Dransfield MT, Bourbeau J, et al. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27–34. PubMed PMID: 25490706.
   PubMed Web of Science ®Google Scholar
• Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;(3):CD010844. PubMed PMID: 24671923. DOI:10.1002/14651858.CD010844.pub2
   PubMed Web of Science ®Google Scholar
• Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014 Mar 10;(3):CD010115. DOI:10.1002/14651858.CD010115.pub2. PubMed PMID: 24615270.
   PubMed Web of Science ®Google Scholar
• Janson C, Stratelis G, Miller-Larsson A, et al. Scientific rationale for the possible inhaled corticosteroid intraclass difference in the risk of pneumonia in COPD. Int J Chron Obstruct Pulmon Dis. 2017;12:3055–3064. PubMed PMID: 29089754; PubMed Central PMCID: PMCPMC5654780.
   PubMed Web of Science ®Google Scholar
• Sibila O, Soto-Gomez N, Restrepo MI. The risk and outcomes of pneumonia in patients on inhaled corticosteroids. Pulm Pharmacol Ther. 2015 Jun;32:130–136. PubMed PMID: 25956073; PubMed Central PMCID: PMCPMC5079105.
   PubMed Web of Science ®Google Scholar
• Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775–789. PubMed PMID: 17314337.
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222–2234. PubMed PMID: 27181606.
   PubMed Web of Science ®Google Scholar
• Horita N, Goto A, Shibata Y, et al. Long-acting muscarinic antagonist (LAMA) plus long-acting beta-agonist (LABA) versus LABA plus inhaled corticosteroid (ICS) for stable chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Feb 10;2:CD012066. PubMed PMID: 28185242.
   PubMed Web of Science ®Google Scholar
• Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963–973. PubMed PMID: 27598678.
   PubMed Web of Science ®Google Scholar
• Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919–1929. PubMed PMID: 28385353.
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnhart F, Brealey N, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018 May 3;378(18):1671–1680. PubMed PMID: 29668352.
   PubMed Web of Science ®Google Scholar
• Cazzola M, Rogliani P, Calzetta L, et al. Triple therapy versus single and dual long-acting bronchodilator therapy in COPD: a systematic review and meta-analysis. Eur Respir J. 2018 Dec;52(6). PubMed PMID: 30309975. DOI:10.1183/13993003.01586-2018.
   Web of Science ®Google Scholar
• Brightling CE, Monteiro W, Ward R, et al. Sputum eosinophilia and short-term response to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2000 Oct 28;356(9240):1480–1485. PubMed PMID: 11081531.
   PubMed Web of Science ®Google Scholar
• Christenson SA, Steiling K, van Den Berge M, et al. Asthma-COPD overlap. Clinical relevance of genomic signatures of type 2 inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Apr 1;191(7):758–766. PubMed PMID: 25611785; PubMed Central PMCID: PMCPMC4407484.
   PubMed Web of Science ®Google Scholar
• Ernst P, Saad N, Suissa S. Inhaled corticosteroids in COPD: the clinical evidence. Eur Respir J. 2015 Feb;45(2):525–537. PubMed PMID: 25537556. .
   PubMed Web of Science ®Google Scholar
• Husebo GR, Bakke PS, Aanerud M, et al. Predictors of exacerbations in chronic obstructive pulmonary disease–results from the Bergen COPD cohort study. PLoS One. 2014;9(10):e109721. PubMed PMID: 25279458; PubMed Central PMCID: PMCPMC4184893.
   PubMed Web of Science ®Google Scholar
• Ortega H, Llanos JP, Lafeuille MH, et al. Burden of disease associated with a COPD eosinophilic phenotype. Int J Chron Obstruct Pulmon Dis. 2018;13:2425–2433. PubMed PMID: 30147308; PubMed Central PMCID: PMCPMC6097826.
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Singh D, Vestbo J, et al. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153–1162. PubMed PMID: 24953015.
   PubMed Web of Science ®Google Scholar
• Siddiqui SH, Guasconi A, Vestbo J, et al. Blood eosinophils: a biomarker of response to extrafine beclomethasone/formoterol in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Aug 15;192(4):523–525. PubMed PMID: 26051430; PubMed Central PMCID: PMCPMC4595668.
   PubMed Web of Science ®Google Scholar
• Calverley P, Vlies B. A rational approach to single, dual and triple therapy in COPD. Respirology. 2016 May;21(4):581–589. PubMed PMID: 26611377. .
   PubMed Web of Science ®Google Scholar
• Watz H, Tetzlaff K, Wouters EF, et al. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390–398. PubMed PMID: 27066739.
   PubMed Web of Science ®Google Scholar
• Usmani OS, Ito K, Maneechotesuwan K, et al. Glucocorticoid receptor nuclear translocation in airway cells after inhaled combination therapy. Am J Respir Crit Care Med. 2005 Sep 15;172(6):704–712. PubMed PMID: 15860753.
   PubMed Web of Science ®Google Scholar
• Haque R, Hakim A, Moodley T, et al. Inhaled long-acting beta2 agonists enhance glucocorticoid receptor nuclear translocation and efficacy in sputum macrophages in COPD. J Allergy Clin Immunol. 2013 Nov;132(5):1166–1173. PubMed PMID: 24070494.
   PubMed Web of Science ®Google Scholar
• Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J. 2002 Jan;19(1):182–191. PubMed PMID: 11843317.
   PubMed Web of Science ®Google Scholar
• Chrischilles E, Gilden D, Kubisiak J, et al. Delivery of ipratropium and albuterol combination therapy for chronic obstructive pulmonary disease: effectiveness of a two-in-one inhaler versus separate inhalers. Am J Manag Care. 2002 Oct;8(10):902–911. PubMed PMID: 12395958.
   PubMed Web of Science ®Google Scholar