Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: A post hoc analysis of the TIOSPIR trial

npj Primary Care Respiratory Medicine

Volumn 25, Issue , 2015, Pages

  Wise, Robert ^a   Calverley, Peter MA ^b   Dahl, Ronald ^c   Dusser, Daniel ^d   Metzdorf, Norbert ^e   Müller, Achim ^e   Fowler, Andy ^f   Anzueto, Antonio ^g  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

^c ODENSE UNIVERSITY HOSPITAL   (Denmark)

^d Institut Cochin   (France)

^e BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^f BOEHRINGER INGELHEIM LTD   (United Kingdom)

^g UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

TIOTROPIUM BROMIDE; CHOLINERGIC RECEPTOR BLOCKING AGENT;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY POWDER INHALER; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY; PARALLEL DESIGN; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SOFT MIST INHALER; AGED; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; NEBULIZER; PATHOPHYSIOLOGY; PROPORTIONAL HAZARDS MODEL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME; VITAL CAPACITY;

ADMINISTRATION, INHALATION; AGED; CHOLINERGIC ANTAGONISTS; DOUBLE-BLIND METHOD; DRY POWDER INHALERS; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; PROPORTIONAL HAZARDS MODELS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIOTROPIUM BROMIDE; TREATMENT OUTCOME; VITAL CAPACITY;

EID: 84946606761     PISSN: None     EISSN: 20551010     Source Type: Journal    
DOI: 10.1038/npjpcrm.2015.67     Document Type: Article

References (28)

1. Boehringer Ingelheim: Summary of Product Characteristics (SPC): Spiriva 18 microgram inhalation powder, hard capsule. EMC. Boehringer Ingelheim Ltd. February 2015. Available at: https://www.medicines.org.uk/emc/medicine/10039.
2. Boehringer Ingelheim: Summary of Product Characteristics (SPC): Spiriva Respimat 2.5 microgram, inhalation solution. EMC. Boehringer Ingelheim Ltd. January 2015. Available at: https://www.medicines.org.uk/emc/medicine/20134l
3. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2014; 7: CD009285.
4. Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs 2012; 72: 273-300.
5. Keating GM. Tiotropium Respimat® Soft Mist inhaler: a review of its use in chronic obstructive pulmonary disease. Drugs 2014; 74: 1801-1816.
6. 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: 1543-1554.
7. Hohlfeld JM, Sharma A, van Noord JA, Cornelissen PJ, Derom E, Towse L et al. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol 2014; 54: 405-414.
8. Boehringer Ingelheim: Tiotropium (Spiriva) Respimat: evaluation of fatal events. Boehringer Ingelheim Ltd. 2010. Available at: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com-EN/results/Pooled%20analysis/PA-205.372-251-252-254-255-U10-3255-01.pdf
9. Dong YH, Lin HH, Shau WY, Wu YC, Chang CH, Lai MS. 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.
10. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342: d3215.
11. Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med 2013; 369: 1491-1501.
12. Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med 2005; 99: 11-19.
13. Kruis AL, Stallberg B, Jones RC, Tsiligianni IG, Lisspers K, van der Molen T et al. Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study. PLoS ONE 2014; 9: e90145.
14. Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M et al. External validity of randomized controlled trials in COPD. Respir Med 2007; 101: 1313-1320.
15. Wise RA, Anzueto A, Calverley P, Dahl R, Dusser D, Pledger G et al. The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale. Respir Res 2013; 14: 40.
16. Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest 2002; 121(5 Suppl): 121S-126S.
17. Celli BR, Barnes PJ. Exacerbations of chronic obstructive pulmonary disease. Eur Respir J 2007; 29: 1224-1238.
18. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57: 847-852.
19. Soler-Cataluna JJ, Martinez-Garcia MA, Roman SP, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60: 925-931.
20. Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global strategy for the diagnosis, management, and prevention of COPD. Available at: http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management html, 2015.
21. Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D et al. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104: 1460-1472.
22. Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G 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: 472-486.
23. Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallelgroup study. Lancet Respir Med 2013; 1: 524-533.
24. Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JA Jr., Korducki L et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005; 143: 317-326.
25. Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J 2010; 36: 65-73.
26. Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364: 1093-1103.
27. Vogelmeier C, Fabbri LM, Rabe KF, Beeh KM, Schmidt H, Metzdorf N et al. Effect of tiotropium vs. salmeterol on exacerbations: GOLD II and maintenance therapy naive patients. Respir Med 2013; 107: 75-83.
28. Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF 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: 199-209.