Cardiac safety of tiotropium in patients with cardiac events: A retrospective analysis of the UPLIFT® trial

Respiratory Research

Volumn 16, Issue 1, 2015, Pages

  Tashkin, Donald P ^a   Leimer, Inge ^b   Metzdorf, Norbert ^b   Decramer, Marc ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

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

^c UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Cardiac safety; COPD; Tiotropium HandiHaler ; UPLIFT

Indexed keywords

PLACEBO; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT;

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; HEART ARRHYTHMIA; HEART DEATH; HEART FAILURE; HEART INFARCTION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; TREATMENT DURATION; TREND STUDY; CARDIOVASCULAR DISEASES; CHEMICALLY INDUCED; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; MALE; MORTALITY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL; TRENDS;

BRONCHODILATOR AGENTS; CARDIOVASCULAR DISEASES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MORTALITY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RETROSPECTIVE STUDIES; TIOTROPIUM BROMIDE;

EID: 84935006716     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/s12931-015-0216-4     Document Type: Article

References (23)

1. Summary of Product Characteristics (SPC): Spiriva Respimat 2.5 microgram, inhalation solution [ http://www.medicines.org.uk/emc/medicine/20134/SPC ]
2. Montuschi P, Macagno F, Valente S, Fuso L. Inhaled muscarinic acetylcholine receptor antagonists for treatment of COPD. Curr Med Chem. 2013;20:1464-76.
3. Montuschi P, Ciabattoni G. Bronchodilating drugs for chronic obstructive pulmonary disease: current status and future trends. J Med Chem. 2015;58:4131-64.
4. Hochrainer D, Holz H, Kreher C, Scaffidi L, Spallek M, Wachtel H. Comparison of the aerosol velocity and spray duration of Respimat Soft Mist inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005;18:273-82.
5. Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat Soft Mist inhaler compared to deposition by metered dose inhaler or by Turbuhaler dry powder inhaler. J Aerosol Med. 2005;18:264-72.
6. Ichinose M, Fujimoto T, Fukuchi Y. Tiotropium 5microg via Respimat and 18microg via HandiHaler; efficacy and safety in Japanese COPD patients. Respir Med. 2010;104:228-36.
7. van Noord JA, Cornelissen PJ, Aumann JL, Platz J, Mueller A, Fogarty C. The efficacy of tiotropium administered via Respimat Soft Mist Inhaler or HandiHaler in COPD patients. Respir Med. 2009;103:22-9.
8. 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.
9. 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.
10. Barr RG, Bourbeau J, Camargo CA, Ram FS. Tiotropium for stable chronic obstructive pulmonary disease: a meta-analysis. Thorax. 2006;61:854-62.
11. Kesten S, Leimer I, Jara M. Risk of major adverse cardiovascular events with inhaled anticholinergics in patients with chronic obstructive pulmonary disease. JAMA. 2009;301:1224-6.
12. Rodrigo GJ, Castro-Rodriguez JA, Nannini LJ, Plaza MV, Schiavi EA. Tiotropium and risk for fatal and nonfatal cardiovascular events in patients with chronic obstructive pulmonary disease: systematic review with meta-analysis. Respir Med. 2009;103:1421-9.
13. Salpeter SR. Do inhaled anticholinergics increase or decrease the risk of major cardiovascular events?: a synthesis of the available evidence. Drugs. 2009;69:2025-33.
14. Tiotropium (Spiriva) Respimat: evaluation of fatal events [ 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 ].
15. 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.
16. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;7:CD009285.
17. 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.
18. Walker S, Fingleton J, Weatherall M, Beasley R. Limited generalisability of UPLIFT findings to clinical practice. Thorax. 2013;68:1066-7.
19. Tashkin DP, Metzdorf N, Hallmann C, Leimer I, Lee T, Decramer M. Authors' response to Walker et al. Thorax. 2014;69:385.
20. Loke YK, Singh S, Furberg CD. Tiotropium and the risk of death in COPD. N Engl J Med. 2014;370:480-1.
21. Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180:948-55.
22. Verhamme KM, Afonso A, Romio S, Stricker BC, Brusselle G, Sturkenboom M. Use of tiotropium Respimat® SMI vs. tiotropium Handihaler® and mortality in patients with COPD. Eur Respir J. 2013;42:606-15.
23. Gershon A, Croxford R, Calzavara A, To T, Stanbrook MB, Upshur R, et al. Cardiovascular safety of inhaled long-acting bronchodilators in individuals with chronic obstructive pulmonary disease. JAMA Intern Med. 2013;173:1175-85.