Cardiac safety of tiotropium in patients with COPD: A combined analysis of Holter-ECG data from four randomised clinical trials

International Journal of Clinical Practice

Volumn 69, Issue 1, 2015, Pages 72-80

  Hohlfeld, J M ^a   Furtwaengler, A ^b   Konen Bergmann M ^b   Wallenstein, G ^b   Walter, B ^c   Bateman, E D ^d  

^a FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

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

^c Independent Consultant   (Germany)

^d UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

TIOTROPIUM BROMIDE; MUSCARINIC RECEPTOR BLOCKING AGENT;

ADULT; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART ARRHYTHMIA; HEART PROTECTION; HEART RATE; HOLTER MONITORING; HUMAN; INHALER; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; PREMATURITY; PRIMARY MEDICAL CARE; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; AGED; DRUG EFFECTS; ELECTROCARDIOGRAPHY; HEART; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL (TOPIC); UTILIZATION;

ADULT; AGED; ELECTROCARDIOGRAPHY; FEMALE; HEART; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIOTROPIUM BROMIDE;

EID: 84920855126     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/ijcp.12596     Document Type: Article

References (22)

1. Boehringer Ingelheim. Innovative solutions to help millions breathe easier, 2013. http://www.boehringer-ingelheim.com/content/dam/internet/opu/com-EN/document/01-news/05-Media-Material/Pipeline-backgrounder-2013.PDF (accessed 25 October 2013).
2. Boehringer Ingelheim. Summary of Product Characteristics (SPC): Spiriva 18 microgram inhalation powder, hard capsule. EMC, 2013. http://www.medicines.org.uk/emc/medicine/10039 (accessed 25 October 2013).
3. Boehringer Ingelheim. Summary of Product Characteristics (SPC): Spiriva Respimat 2.5 microgram solution for inhalation. EMC, 2013. http://www.medicines.org.uk/emc/medicine/20134 (accessed 19 July 2013).
4. van Noord JA, Cornelissen PJ, Aumann JLlatz 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.
5. Bateman E, Singh D, Smith 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; 5: 197-208.
6. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104: 1460-72.
7. Cooper CB, Celli BR, Jardim JR, et al. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest 2013; 144: 490-7.
8. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
9. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364: 1093-103.
10. Wise RA, Anzueto A, Cotton D, et al. Tiotropium respimat inhaler and the risk of death in COPD. N Engl J Med 2013; 369: 1491-501.
11. 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.
12. Hohlfeld JM, Sharma A, van Noord JA, et al. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol 2014; 54: 405-14.
13. Karner C, Chong Joole P,. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012; 7: CD009285.
14. Celli B, Decramer M, Leimer I, Vogel U, Kesten S, Tashkin DP,. Cardiovascular safety of tiotropium in patients with COPD. Chest 2010; 137: 20-30.
15. Singh S, Loke YK, Enright P, Furberg CD,. Pro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications. Thorax 2013; 68: 114-6.
16. 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.
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. Verhamme KM, Afonso A, Romio S, Stricker BC, Brusselle GG, Sturkenboom MC,. Use of tiotropium Respimat Soft Mist Inhaler versus HandiHaler and mortality in patients with COPD. Eur Respir J 2013; 42: 606-15.
19. Barr RG, Bourbeau J, Camargo CA, Ram FS,. Tiotropium for stable chronic obstructive pulmonary disease: a meta-analysis. Thorax 2006; 61: 854-62.
20. 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.
21. Rodrigo GJ, Castro-Rodriguez JA, Nannini LJlaza Moral V, 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.
22. Covelli H, Bhattacharya S, Cassino C, Conoscenti C, Kesten S,. Absence of electrocardiographic findings and improved function with once-daily tiotropium in patients with chronic obstructive pulmonary disease. Pharmacotherapy 2005; 25: 1708-18.