Comparative mortality risk of tiotropium administered via handihaler or respimat in COPD patients: Are they equivalent?

Pulmonary Pharmacology and Therapeutics

Volumn 28, Issue 2, 2014, Pages 91-97

  Mathioudakis, Alexander G ^a,b   Chatzimavridou Grigoriadou, Victoria ^b   Evangelopoulou, Efstathia ^b,c   Mathioudakis, Georgios A ^b,d   Siafakas, Nikolaos M ^e  

^a UNIVERSITY HOSPITAL AINTREE   (United Kingdom)

^b Respiratory Assembly Hellenic Society for the Advancement of Biomedical Research   (Greece)

^c GENERAL HOSPITAL OF NIKEA   (Greece)

^d IASO GENERAL HOSPITAL   (Greece)

^e UNIVERSITY OF CRETE   (Greece)

Author keywords

COPD; Human; ICS; LABA; LAMA; RCT; Respimat; SABA; Safety; SAMA; Systematic review; Tiotropium

Indexed keywords

FLUTICASONE PROPIONATE PLUS SALMETEROL; PLACEBO; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT; SCOPOLAMINE DERIVATIVE;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG FORMULATION; DRUG SAFETY; DRUG WITHDRAWAL; DRY POWDER INHALER; HEART INFARCTION; HUMAN; KIDNEY DISEASE; LOW DRUG DOSE; META ANALYSIS (TOPIC); METERED DOSE INHALER; MORTALITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SOFT MIST INHALER; SYSTEMATIC REVIEW; CARDIOVASCULAR DISEASES; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; NEBULIZER; PATHOPHYSIOLOGY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE;

ADMINISTRATION, INHALATION; BRONCHODILATOR AGENTS; CARDIOVASCULAR DISEASES; HUMANS; METERED DOSE INHALERS; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; SCOPOLAMINE DERIVATIVES;

EID: 84904127467     PISSN: 10945539     EISSN: 15229629     Source Type: Journal    
DOI: 10.1016/j.pupt.2014.04.009     Document Type: Review

References (42)

1. From the Global Strategy for the Diagnosis Management and prevention of COPD, global initiative for chronic obstructive lung disease (GOLD) 2014, Available from:. http://www.goldcopd.org/.
2. Tashkin D.P., Celli B., Senn S., Burkhart D., Kesten S., Menjoge S., et al. A4-year trial of tiotropium in chronic obstructive pulmonary disease. NEngl J Med 2008 Oct 9, 359(15):1543-1554. UPLIFT Study Investigators, Epub 2008 Oct 5. 10.1056/NEJMoa0805800.
3. Vogelmeier C., Hederer B., Glaab T., Schmidt H., Rutten-van Mölken M.P., Beeh K.M., et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. NEngl J Med 2011 Mar 24, 364(12):1093-1103. POET-COPD Investigators. 10.1056/NEJMoa1008378.
4. Wedzicha J.A., Calverley P.M., Seemungal T.A., Hagan G., Ansari Z., Stockley R.A. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008 Jan 1, 177(1):19-26. INSPIRE Investigators.
5. Cooper C.B., Celli B.R., Jardim J.R., Wise R.A., Legg D., Guo J., et al. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomised trial. Chest 2013 Aug, 144(2):490-497. 10.1378/chest.12-2613.
6. Barnes P.J., Belvisi M.G., Mak J.C., Haddad E.B., O'Connor B. Tiotropium bromide (Ba 679 BR), a novel long-acting muscarinic antagonist for the treatment of obstructive airways disease. Life Sci 1995, 56(11-12):853-859.
7. Singh S., Loke Y.K., Furberg C.D. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAm Med Assoc 2008 Sep 24, 300(12):1439-1450.
8. Verhamme K.M., van Blijderveen N., Sturkenboom M.C. Tiotropium and the risk of death in COPD. NEngl J Med 2014 Jan 30, 370(5):481-482.
9. Dalby R., Spallek M., Voshaar T. Areview of the development of respimat soft mist inhaler. Int J Pharm 2004 Sep 28, 283(1-2):1-9.
10. Mathioudakis A.G., Kanavidis P., Chatzimavridou-Grigoriadou V., Gialmanidis I.P., Amanetopoulou S.G., Christopoulou E., et al. Tiotropium handihaler improves the survival of patients with COPD: a systematic review and meta-analysis. JAerosol Med Pulm Drug Deliv 2014 Feb, 27(1):43-50. 10.1089/jamp.2012.1012.
11. Schulz K.F., Grimes D.A. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet 2002 Mar 2, 359(9308):781-785.
12. Scichilone N., Basile M., Battaglia S., Bellia V. What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?. Respiration 2013 Nov 20, [Epub ahead of print].
13. Wise R.A., Anzueto A., Cotton D., Dahl R., Devins T., Disse B., et al. Tiotropium Respimat inhaler and the risk of death in COPD. NEngl J Med 2013 Oct 17, 369(16):1491-1501.
14. Michele T.M., Pinheiro S., Iyasu S. The safety of tiotropium-the FDA's conclusions. NEngl J Med 2010 Sep 16, 363(12):1097-1099.
15. Celli B., Decramer M., Leimer I., Vogel U., Kesten S., Tashkin D.P. Cardiovascular safety of tiotropium in patients with COPD. Chest 2010 Jan, 137(1):20-30.
16. Cooper C.B., Celli B.R., Jardim J.R., Wise R.A., Legg D., Guo J., et al. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest 2013 Aug, 144(2):490-497.
17. Short P.M., Williamson P.A., Elder D.H., Lipworth S.I., Schembri S., Lipworth B.J. The impact of tiotropium on mortality and exacerbations when added to inhaled corticosteroids and long-acting β-agonist therapy in COPD. Chest 2012 Jan, 141(1):81-86. Epub 2011 Jul 28. 10.1378/chest.11-0038.
18. Verhamme K.M., Afonso A.S., van Noord C., Haag M.D., Koudstaal P.J., Brusselle G.G., et al. Tiotropium handihaler and the risk of cardio- or cerebrovascular events and mortality in patients with COPD. Pulm Pharmacol Ther 2012 Feb, 25(1):19-26. 10.1016/j.pupt.2011.10.004.
19. Sicras-Mainar A., Velasco-Velasco S., Llopart-López J.R., Navarro-Artieda R., de Haro-Martí L. Calculation of morbidity, use of resources and costs of patients treated with tiotropium bromide for COPD in a Spanish population. Aten Primaria 2007 Oct, 39(10):547-555.
20. Voshaar T., Lapidus R., Maleki-Yazdi R., Timmer W., Rubin E., Lowe L., et al. Arandomized study of tiotropium respimat soft mist inhaler vs. ipratropium pMDI in COPD. Respir Med 2008 Jan, 102(1):32-41.
21. Hohlfeld J.M., Sharma A., van Noord J.A., Cornelissen P.J., Derom E., Towse L., et al. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. JClin Pharmacol 2013 Oct 25.
22. Ichinose M., Fujimoto T., Fukuchi Y. Tiotropium 5microg via Respimat and 18 microg via HandiHaler; efficacy and safety in Japanese COPD patients. Respir Med 2010 Feb, 104(2):228-236. Epub 2009 Dec 6. 10.1016/j.rmed.2009.11.011.
23. van Noord J.A., Cornelissen P.J.G., Aumann J.L., Platz J., Mueller A., Fogarty C. The efficacy of tiotropium administered via respimat soft mist inhaler or handihaler in COPD patients. Respir Med 2009 Jan, 103(1):22-29.
24. Wise R.A., Anzueto A., Cotton D., Dahl R., Devins T., Disse B., et al. Tiotropium respimat inhaler and the risk of death in COPD. NEngl J Med 2013 Oct 17, 369(16):1491-1501. TIOSPIR Investigators.
25. Abrahams R., Moroni-Zentgraf P., Ramsdell J., Schmidt H., Joseph E., Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 comparedwith tiotropium in patients with COPD. Respir Med 2013 Jun, 107(6):854-862.
26. Bateman E.D., Singh D., Smith D., Disse B., Towse L., Massey D., et al. Efficacy and safety of tiotropium respimat SMI in COPD in two 1-year randomized studies. Int J Chron Obstruct Pulmon Dis 2010 Aug 9, 5:197-208.
27. Bateman E.D., Tashkin D., Siafakas N., Dahl R., Towse L., Massey D., et al. Aone-year trial of tiotropium respimat plus usual therapy in COPD patients. Respir Med 2010 Oct, 104(10):1460-1472.
28. NCT01040403: Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD).
29. Singh S., Loke Y.K., Enright P.L., Furberg C.D. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. Br Med J 2011, 342:d3215.
30. Karner C., Chong J., Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012 Jul 11, 7:CD009285.
31. Beasley R. Tiotropium respimat increases the risk of mortality: pro. Eur Respir J 2013 Sep, 42(3):584-589.
32. Dong Y.H., Lin H.H., Shau W.Y., Wu Y.C., Chang C.H., Lai M.S. Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. Thorax 2013, 68:48-56.
33. Bateman E.D. Tiotropium respimat increases the risk of mortality: con. Eur Respir J 2013 Sep, 42(3):590-593.
34. Beasley R., Singh S., Loke Y.K., Enright P., Furberg C.D. Call for worldwide withdrawal of tiotropium respimat mist inhaler. Br Med J 2012 Nov 9, 345:e7390.
35. Vestbo J., Hurd S.S., Agustí A.G., Jones P.W., Vogelmeier C., 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 2013 Feb 15, 187(4):347-365.
36. Wise R.A., Anzueto A., Calverley P., Dahl R., Dusser D., Pledger G. The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale. Respir Res 2013 Apr 2, 14:40. 10.1186/1465-9921-14-40.
37. Loke Y.K., Singh S., Furberg C.D. Tiotropium and the risk of death in COPD. NEngl J Med 2014 Jan 30, 370(5):480-481.
38. Verhamme K.M., Afonso A., Romio S., Stricker B.C., Brusselle G.G., Sturkenboom M.C. Use of tiotropium Respimat Soft Mist Inhaler versus HandiHaler and mortality in patients with COPD. Eur Respir J 2013 Sep, 42(3):606-615.
39. Gershon A., Croxford R., Calzavara A., To T., Stanbrook M.B., Upshur R., et al. Cardiovascular safety of inhaled long-acting bronchodilators in individuals with chronic obstructive pulmonary disease. JAMA Intern Med 2013, 173:1175-1184.
40. Verhamme K.M., van Blijderveen N., Sturkenboom M.C. Tiotropium and the risk of death in COPD. NEngl J Med 2014 Jan 30, 370(5):481-482.
41. Mathioudakis A.G., Mathioudakis G.A. Tiotropium inhaler devices: seeking convenience when mortality is at stake?. JAerosol Med Pulm Drug Deliv 2013 Apr, 26(2):120.
42. Summary of Product Characteristics (SPC): Spiriva Respimat 2.5 microgram solution for inhalation. eMC 2013, Boehringer Ingelheim, http://www.medicines.org.uk/emc/medicine/20134/SPC.