바로가기메뉴

본문 바로가기 주메뉴 바로가기

The Role of Tiotropium+Olodaterol Dual Bronchodilator Therapy in the Management of Chronic Obstructive Pulmonary Disease

Tuberculosis & Respiratory Diseases / Tuberculosis & Respiratory Diseases,
2018, v.81 no.1, pp.13-18
David M. G. Halpin (Royal Devon and Exeter Hospital)
D.Phil. M.B.B.S. (Royal Devon and Exeter Hospital)
  • Downloaded
  • Viewed

Abstract

Bronchodilator therapy is central to the management of chronic obstructive pulmonary disease and are recommended as the preferred treatment by the Global Obstructive Lung Disease Initiative (GOLD). Long acting anti-muscarinics (LAMA) and long acting β2 agonists (LABA) are both more effective than regular short-acting drugs but many patients remain symptomatic despite monotherapy with these drugs. Combination therapy with LAMA and LABA increases the therapeutic benefit while minimizing dose-dependent side effects of long-acting bronchodilator therapy. The TOviTO programme has investigated the benefits of treatment with a combination of tiotropium and olodaterol administered via a single inhaler. Tiotropium+olodaterol 5/5 µg significantly improved forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours, trough FEV1 health status and breathlessness versus the mono-components and placebo. Tiotropium+olodaterol 5/5 µg also increased endurance time and reduced dynamic hyperinflation during constant work rate cycle ergometry. On the basis of these and other studies the 2017 GOLD report recommends escalating to dual bronchodilator therapy in patients in groups B and C if they remain symptomatic or continue to have exacerbations and as initial therapy for patients in group D.

keywords
Pulmonary Disease, Chronic Obstructive, Tiotropium, Olodaterol

Reference

1.

Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD Executive Summary. Am J Respir Crit Care Med 2017;195:557-82.

2.

Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW. Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax 2003;58:659-64.

3.

Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-54.

4.

Pisi R, Aiello M, Zanini A, Tzani P, Paleari D, Marangio E, et al. Small airway dysfunction and flow and volume bronchodilator responsiveness in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 2015;10:1191-7.

5.

Walker PP, Calverley PM. The volumetric response to bronchodilators in stable chronic obstructive pulmonary disease. COPD 2008;5:147-52.

6.

Calverley PM. AJRCCM: 100-year anniversary. Physiology and chronic obstructive pulmonary disease in the blue journals. Am J Respir Crit Care Med 2017;195:1088-90.

7.

O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001;164:770-7.

8.

Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res 2011;12:161.

9.

Donohue JF, Jones P, Bartels C, Marvel J, D'Andrea P, Banerji D, et al. Relationship between change in trough FEV1 and COPD patient outcomes: pooled analysis of 23 clinical trials in patients with COPD. Eur Respir J 2015;46(Suppl 59):PA1013.

10.

Ram FS, Sestini P. Regular inhaled short acting <TEX>${\beta}_{2}$</TEX> agonists for the management of stable chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis. Thorax 2003;58:580-4.

11.

Gross N, Tashkin D, Miller R, Oren J, Coleman W, Linberg S. Inhalation by nebulization of albuterol-ipratropium combination (Dey combination) is superior to either agent alone in the treatment of chronic obstructive pulmonary disease. Dey Combination Solution Study Group. Respiration 1998;65:354-62.

12.

In chronic obstructive pulmonary disease, a combination of ipratropium and albuterol is more effective than either agent alone: an 85-day multicenter trial. COMBIVENT Inhalation Aerosol Study Group. Chest 1994;105:1411-9.

13.

Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ Jr, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002;122:47-55.

14.

D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011;12:156.

15.

Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775-89.

16.

Rossi A, Kristufek P, Levine BE, Thomson MH, Till D, Kottakis J, et al. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 2002;121:1058-69.

17.

Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B, et al. Long-term safety and efficacy of indacaterol, a long-acting <TEX>${\beta}_{2}$</TEX>-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest 2011;140:68-75.

18.

Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF, et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012;9:90-101.

19.

Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis 2012;7:503-13.

20.

Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, et al. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med 2011;105:580-7.

21.

O'Donnell DE, Fluge T, Gerken F, Hamilton A, Webb K, Aguilaniu B, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004;23:832-40.

22.

O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, et al. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med 2011;105:1030-6.

23.

Halpin DM, Vogelmeier C, Pieper MP, Metzdorf N, Richard F, Anzueto A. Effect of tiotropium on COPD exacerbations: a systematic review. Respir Med 2016;114:1-8.

24.

Busch-Petersen J, Laine DI. Inhaled long-acting muscarinic antagonists in chronic obstructive pulmonary disease. Future Med Chem 2011;3:1623-34.

25.

Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs 2012;72:273-300.

26.

Bouyssou T, Casarosa P, Naline E, Pestel S, Konetzki I, Devillier P, et al. Pharmacological characterization of olodaterol, a novel inhaled <TEX>${\beta}_{2}$</TEX>-adrenoceptor agonist exerting a 24-hourlong duration of action in preclinical models. J Pharmacol Exp Ther 2010;334:53-62.

27.

Ferguson GT, Feldman GJ, Hofbauer P, Hamilton A, Allen L, Korducki L, et al. Efficacy and safety of olodaterol once daily delivered via Respimat(R) in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis 2014;9:629-45.

28.

Koch A, Pizzichini E, Hamilton A, Hart L, Korducki L, De Salvo MC, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat(R) versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis 2014;9:697-714.

29.

Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J 2011;20:46-53.

30.

Singh D. New combination bronchodilators for chronic obstructive pulmonary disease: current evidence and future perspectives. Br J Clin Pharmacol 2015;79:695-708.

31.

Tashkin DP, Ferguson GT. Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease. Respir Res 2013;14:49.

32.

Cohen JS, Miles MC, Donohue JF, Ohar JA. Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA. Int J Chron Obstruct Pulmon Dis 2016;11:785-97.

33.

Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, et al. Randomized, double-blind, dosefinding study for tiotropium when added to olodaterol, administered via the Respimat(R) inhaler in patients with chronic obstructive pulmonary disease. Adv Ther 2015;32:809-22.

34.

ZuWallack R, Allen L, Hernandez G, Ting N, Abrahams R. Efficacy and safety of combining olodaterol Respimat((R)) and tiotropium HandiHaler((R)) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis 2014;9:1133-44.

35.

Keating GM. Tiotropium Respimat((R)) Soft Mist inhaler: a review of its use in chronic obstructive pulmonary disease. Drugs 2014;74:1801-16.

36.

Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat Soft Mist inhaler than HFAMDI in COPD patients with poor technique. Int J Chron Obstruct Pulmon Dis 2008;3:763-70.

37.

Spiolto Respimat in COPD [Internet]. Ingelheim am Rhein: Boehringer Ingelheim; 2017 [cited 2017 Jul 1]. Available from: http://www.boehringer-ingelheim.com/copd/copd/information-tovito-clinical-trial-program.

38.

Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J 2015;45:969-79.

39.

Punekar YS, Sharma S, Pahwa A, Takyar J, Naya I, Jones PW. Rescue medication use as a patient-reported outcome in COPD: a systematic review and regression analysis. Respir Res 2017;18:86.

40.

Ferguson GT, Flezar M, Korn S, Korducki L, Gronke L, Abrahams R, 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;32:523-36.

41.

Ferguson GT, Karpel JP, Clerisme-Beaty E, Gronke L, Voss F, Buhl R. 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;11:2701-10.

42.

Singh D, Ferguson GT, Bolitschek J, Gronke L, Hallmann C, Bennett N, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med 2015;109:1312-9.

43.

Ferguson GT, Karpel J, Bennett N, Clerisme-Beaty E, Gronke L, Voss F, 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;27:7.

44.

Singh D, Gaga M, Schmidt O, Bjermer L, Gronke L, Voss F, et al. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res 2016;17:73.

45.

Martinez FJ, Abrahams R, Ferguson GT, Bjermer L, Gronke L, Vob F, et al. Effects of symptom severity at baseline on lungfunction and SGRQ responses in the OTEMTO studies. Am J Respir Crit Care Med 2016;193:A6787.

46.

Thomas M, Halpin DM, Miravitlles M. When is dual bronchodilation indicated in COPD? Int J Chron Obstruct Pulmon Dis 2017;12:2291-305.

47.

Donohue JF, Singh D, Munzu C, Kilbride S, Church A. Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: results from two randomised controlled trials. Respir Med 2016;112:65-74.

48.

Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, et al. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res 2017;18:140.

49.

Maltais F, Galdiz Iturri JB, Kirsten A, Singh D, Hamilton A, Tetzlaff K, et al. Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD. Thorax 2014;69(Suppl 2):A186-7.

50.

Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008;177:19-26.

51.

Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:2222-34.

52.

Toy EL, Beaulieu NU, McHale JM, Welland TR, Plauschinat CA, Swensen A, et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med 2011;105:435-41.

Tuberculosis & Respiratory Diseases