Efficacy and safety of LABA/LAMA fixed-dose combinations approved in the US for the management of COPD

References

• Global initiative for chronic Obstructive Lung Disease (GOLD 2014). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2015 [cited 2016 Feb 4]. Available from: www.goldcopdorg/uploads/users/files/GOLD_Report_2015pdf2015
   Google Scholar
• Ribeiro M, Chapman KR. Comparative efficacy of indacaterol in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2012;7:145–152.
   PubMed Web of Science ®Google Scholar
• Deeks ED. Olodaterol: a review of its use in chronic obstructive pulmonary disease. Drugs. 2015;75(6):665–673.
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Fabbri LM. Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents. Respir Res. 2010;11:149.
   PubMed Web of Science ®Google Scholar
• Yohannes AM, Connolly MJ, Hanania NA. Ten years of tiotropium: clinical impact and patient perspectives. Int J Chron Obstruct Pulmon Dis. 2013;8:117–125.
   PubMed Web of Science ®Google Scholar
• Molimard M, D’Andrea P. Once-daily glycopyrronium via the Breezhaler device for the treatment of COPD: pharmacological and clinical profile. Expert Rev Clin Pharmacol. 2013;6(5):503–517.
   PubMed Web of Science ®Google Scholar
• Jones PW. Clinical potential of aclidinium bromide in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015;10:677–687.
   PubMed Web of Science ®Google Scholar
• Trivedi R, Richard N, Mehta R, et al. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J. 2014;43(1):72–81.
   PubMed Web of Science ®Google Scholar
• Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mg in COPD. Respir Med. 2013;107(10):1538–1546.
   PubMed Web of Science ®Google Scholar
• Dransfield MT, Bailey W, Crater G, et al. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011;20(1):46–53.
   PubMedGoogle Scholar
• GlaxoSmithKline (GSK). Anoro Ellipta prescribing information [Internet]. [revised 2014 May; cited 2015 Nov 18]. Available from: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Anoro_Ellipta/pdf/ANORO-ELLIPTA-PI-MG.PDF
   Google Scholar
• Boehringer Ingelheim. STIOLTO RESPIMAT prescribing information [Internet]. [ revised 2015 May; cited 2015 Jun 15]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf
   Google Scholar
• Novartis. UTIBRON NEOHALER prescribing information [Internet]. [ revised 2015 Oct; cited 2015 Nov 13]. Available from: http://pharma.us.novartis.com/product/pi/pdf/utibron.pdf
   Google Scholar
• Electronic Medicines Compendium (EMC). Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed. SmPC [ updated 2015 Mar; cited 2015 Oct 8]. Available from: www.medicinesorguk/emc/medicine/289492015
   Google Scholar
• Electronic Medicines Compendium (EMC). Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution. SmPC [updated 2015 Jun; cited 2015 Oct 8]. Available from: www.medicinesorguk/emc/medicine/304952015
   Google Scholar
• Electronic Medicines Compendium (EMC). Onbrez Breezhaler 150 and 300 microgram inhalation powder, hard capsules. SmPC [ updated 2014 Sep; cited 2015 Oct 8]. Available from: www.medicinesorguk/emc/medicine/232602014
   Google Scholar
• Novartis. ARCAPTA NEOHALER prescribing information [Internet]. [ revised 2012 Sept; cited 2015 Nov 20]. Available from: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM263031.pdf
   Google Scholar
• Electronic Medicines Compendium (EMC). Seebri Breezhaler inhalation powder, hard capsules 44mcg [Internet]. SmPC [ updated 2015 Jul; cited 2015 Oct 8]. Available from: www.medicinesorguk/emc/medicine/271382015
   Google Scholar
• Novartis. SEEBRI NEOHALER prescribing information [Internet]. [ revised 2015 Oct; cited 2015 Nov 18]. Available from: http://pharma.us.novartis.com/product/pi/pdf/seebri.pdf
   Google Scholar
• Donohue JF. Low doses of long-acting beta-agonists/long-acting muscarinic agents with large effects. The FLIGHT study. Am J Respir Crit Care Med. 2015;192(9):1028–1030.
   PubMed Web of Science ®Google Scholar
• Mahler DA, Kerwin E, Ayers T, et al. FLIGHT1 and FLIGHT2: efficacy and safety of QVA149 (indacaterol/glycopyrrolate) versus its monocomponents and placebo in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015;192(9):1068–1079.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, FowlerTaylor A, Thach C, et al. QVA149 is safe and well tolerated in patients with moderate-to-severe COPD: FLIGHT3, a 52-week safety study. Am J Respir Crit Care Med. 2015;191(1):A5762 (Abstract).
   Google Scholar
• Decramer M, Anzueto A, Kerwin E, et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014;2(6):472–486.
   PubMed Web of Science ®Google Scholar
• Maleki-Yazdi MR, Kaelin T, Richard N, et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir Med. 2014;108(12):1752–1760.
   PubMed Web of Science ®Google Scholar
• Donohue JF, Worsley S, Zhu C-Q, et al. Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med. 2015;109(7):870–881.
   PubMed Web of Science ®Google Scholar
• Singh D, Worsley S, Zhu C-Q, et al. Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. BMC Pulm Med. 2015;15:91.
   PubMed Web of Science ®Google Scholar
• Maltais F, Singh S, Donald AC, et al. Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014;8(6):169–181.
   PubMed Web of Science ®Google Scholar
• Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur Respir J. 2015;45(4):969–979.
   PubMed Web of Science ®Google Scholar
• Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015;109(10):1312–1319.
   PubMed Web of Science ®Google Scholar
• Beeh K-M, Westerman J, Kirsten A-M, et al. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015;32:53–59.
   PubMed Web of Science ®Google Scholar
• Beeh K-M, Derom E, Echave-Sustaeta JM, et al. ENERGITO: efficacy and safety of once-daily combined tiotropium + olodaterol versus twice-daily combined fluticasone propionate + salmeterol. Eur Respir J. 2015;46(Suppl. 59):AbstractPA4366.
   Google Scholar
• Donohue JF, Niewoehner D, Brooks J, et al. Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir Res. 2014;15:78.
   PubMed Web of Science ®Google Scholar
• Ferguson G, Pizzichini E, Flezar M, et al. The fixed-dose combination of tiotropium + olodaterol has a rapid onset of action in patients with COPD. Eur Respir J. 2015;46(Suppl. 59):AbstractPA2957.
   Google Scholar
• Ferguson GT, Fležar M, Korn S, et al. Efficacy of tiotropium + olodaterol in patients with chronic obstructive pulmonary disease by initial disease severity and treatment intensity: a post hoc analysis. Adv Ther. 2015;32(6):523–536.
   PubMed Web of Science ®Google Scholar
• Mahler DA, Witek TJ Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD. 2005;2(1):99–103.
   PubMedGoogle Scholar
• Food and Drug Administration (FDA). Briefing document. Pulmonary-allergy drugs advisory committee meeting. NDA 203-975: umeclidinium and vilanterol inhalation powder for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) [ updated 2013 Sep 10; cited 2015 Oct 23]. Available from: www.fdagov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/pulmonary-allergydrugsadvisorycommittee/ucm367411pdf2013
   Google Scholar
• Jones PW. St. George’s respiratory questionnaire: MCID. COPD. 2005;2(1):75–79.
   PubMedGoogle Scholar
• Clinicaltrials.gov. NCT02487446: efficacy and safety study of QVA149 in COPD patients [Internet]. [ updated 2015; cited 2015 Nov 20]. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02487446
   Google Scholar
• Clinicaltrials.gov. NCT02487498: efficacy and safety study of indacaterol maleate/glycopyrronium bromide in COPD patients [Internet]. [ updated 2015; cited 2015 Dec 1]. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02487498
   Google Scholar
• Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):99–209.
   PubMed Web of Science ®Google Scholar
• Zhong N, Wang C, Zhou X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J COPD. 2015;10:1015–1026.
   Google Scholar
• ClinicalTrials.gov. NCT02296138. Comparing the efficacy of tiotropium + olodaterol (5/5 µg) fixed dose combination (FDC) over tiotropium 5µg in reducing moderate to severe exacerbations in patients with severe to very severe chronic obstructive pulmonary disease [Internet]. [ updated 2015 Jun 16; cited 2015 Jul 15]. Available from: https://clinicaltrials.gov/ct2/results?term=NCT02296138
   Google Scholar
• Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(3):371–384.
   PubMedGoogle Scholar
• Lareau SC, Yawn BP. Improving adherence with inhaler therapy in COPD. Int J Chron Obstruct Pulmon Dis. 2010;5:401–406.
   PubMedGoogle Scholar
• Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008;63(9):831–838.
   PubMed Web of Science ®Google Scholar
• Toy EL, Beaulieu NU, McHale JM, et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med. 2011;105(3):435–441.
   PubMed Web of Science ®Google Scholar
• Agustí A, Vestbo J. Current controversies and future perspectives in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2011;184(5):507–513.
   PubMed Web of Science ®Google Scholar
• Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371(14):1285–1294.
   PubMed Web of Science ®Google Scholar
• Price D, West D, Brusselle G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life prescribing patterns. Int J Chron Obstruct Pulmon Dis. 2014;9:889–905.
   PubMed Web of Science ®Google Scholar
• Yawn BP, Li Y, Tian H, et al. Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis. Int J Chron Obstruct Pulmon Dis. 2013;8:295–304.
   PubMed Web of Science ®Google Scholar
• Crim C, Calverley PM, Anderson JA, et al. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009;34(3):641–647.
   PubMed Web of Science ®Google Scholar
• Barnes PJ. Inhaled corticosteroids in COPD: a controversy. Respiration. 2010;80(2):89–95.
   PubMed Web of Science ®Google Scholar
• Suissa S, Patenaude V, Lapi F, et al. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax. 2013;68(11):1029–1036.
   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;12(1):27–34.
   PubMed Web of Science ®Google Scholar
• Suissa S, Coulombe J, Ernst P. Discontinuation of inhaled corticosteroids in COPD and the risk reduction of pneumonia. Chest. 2015;148(5):1177–1183.
   PubMed Web of Science ®Google Scholar
• Miravitlles M, Soler-Cataluña JJ, Calle M, et al. Treatment of COPD by clinical phenotypes: putting old evidence into clinical practice. Eur Respir J. 2013;41(6):1252–1256.
   PubMed Web of Science ®Google Scholar
• Han MK, Agusti A, Calverley PM, et al. Chronic obstructive pulmonary disease phenotypes: the future of COPD. Am J Respir Crit Care Med. 2010;182(5):598–604.
   PubMed Web of Science ®Google Scholar
• Koblizek V, Chlumsky J, Zindr V, et al. Chronic obstructive pulmonary disease: official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2013;157(2):189–201.
   PubMed Web of Science ®Google Scholar
• Kankaanranta H, Harju T, Kilpeläinen M, et al. Diagnosis and pharmacotherapy of stable chronic obstructive pulmonary disease: the Finnish guidelines. Basic Clin Pharmacol Toxicol. 2014;116(4):291–307.
   Web of Science ®Google Scholar
• Miravitlles M, Soler-Cataluña JJ, Calle M, et al. Spanish guideline for COPD (GesEPOC). Arch Bronconeumol. 2014;50(Suppl 1):1–16. Update 2014.
   PubMed Web of Science ®Google Scholar
• GlaxoSmithKline (GSK). GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD [Internet]. [ updated 2014 Jul; cited 2015 Oct 23]. Available from: http://www.gsk.com/en-gb/media/press-releases/2014/gsk-and-theravance-announce-initiation-of-phase-iii-programme-with-fixed-dose-triple-combination-treatment-ffumecvi-in-patients-with-copd/
   Google Scholar