Tiotropium handihaler® and respimat®in copd: A pooled safety analysis

International Journal of COPD

Volumn 10, Issue , 2015, Pages 239-259

  Halpin, David M G ^a   Dahl, Ronald ^b   Hallmann, Christoph ^c   Mueller, Achim ^c   Tashkin, Donald ^d  

^a ROYAL DEVON AND EXETER HOSPITAL   (United Kingdom)

^b ODENSE UNIVERSITY HOSPITAL   (Denmark)

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

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

HandiHaler ; Respimat ; Tiotropium

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; PLACEBO; SHORT ACTING DRUG; THEOPHYLLINE; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT; MUSCARINIC RECEPTOR BLOCKING AGENT; SCOPOLAMINE DERIVATIVE;

ABDOMINAL PAIN; ADULT; AGED; ANEURYSM; ANXIETY DISORDER; ARTICLE; AUTOMUTILATION; BLURRED VISION; CEREBROVASCULAR ACCIDENT; CHRONIC OBSTRUCTIVE LUNG DISEASE; COGNITIVE DEFECT; CONFUSION; CONSTIPATION; CONTROLLED STUDY; DEHYDRATION; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRY POWDER INHALER; DYSPEPSIA; DYSPHAGIA; DYSURIA; FAINTNESS; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL OBSTRUCTION; GLAUCOMA; HEADACHE; HEART ARREST; HEART ARRHYTHMIA; HEART ATRIUM FLUTTER; HEART DISEASE; HEART FAILURE; HEART FIBRILLATION; HEART INFARCTION; HEART PALPITATION; HEART VENTRICLE TACHYCARDIA; HOSPITALIZATION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; INSOMNIA; ISCHEMIC HEART DISEASE; KIDNEY DISEASE; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MORTALITY; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; RESTLESSNESS; SLEEP DISORDER; SOFT MIST INHALER; STOMATITIS; SUPRAVENTRICULAR TACHYCARDIA; TREATMENT DURATION; TREATMENT RESPONSE; URINARY TRACT INFECTION; URINE RETENTION; XEROSTOMIA; DRUG EFFECTS; EQUIPMENT DESIGN; INHALATIONAL DRUG ADMINISTRATION; LUNG; META ANALYSIS; MIDDLE AGED; NEBULIZER; ODDS RATIO; PATHOPHYSIOLOGY; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME; VITAL CAPACITY;

ADMINISTRATION, INHALATION; AGED; BRONCHODILATOR AGENTS; EQUIPMENT DESIGN; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; LUNG; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; NEBULIZERS AND VAPORIZERS; ODDS RATIO; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; SCOPOLAMINE DERIVATIVES; TIME FACTORS; TIOTROPIUM BROMIDE; TREATMENT OUTCOME; VITAL CAPACITY;

EID: 84922643059     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S75146     Document Type: Article

References (65)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. GOLD; updated 2014. Available from: http://www.goldcopd.com/uploads/users/fles/GOLD_Report_2014_Oct30.pdf. Accessed December 15, 2014.
2. Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax. 2003;58:399–404.
3. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;19:217–224.
4. Tashkin DP, Cooper CB. The role of long-acting bronchodilators in the management of stable COPD. Chest. 2004;125:249–259.
5. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359:1543–1554.
6. Vincken W, van Noord JA, Greefhorst AP, et al; Dutch/Belgian Tiotro-pium Study Group. Improved health outcomes in patients with COPD during 1 yr’s treatment with tiotropium. Eur Respir J. 2002;19:209–216.
7. Dusser D, Bravo ML, Iacono P. The effect of tiotropium on exacerbations and airfow in patients with COPD. Eur Respir J. 2006;27:547–555.
8. Halpin D, Menjoge S, Viel K. Patient-level pooled analysis of the effect of tiotropium on COPD exacerbations and related hospitalisations. Prim Care Respir J. 2009;18:106–113.
9. Niewoehner DE, Rice K, Cote C, 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.
10. Boehringer Ingelheim. Spiriva 18 microgram inhalation powder, hard capsule. Summary of Product Characteristics (SPC), Electonic Medicines Compendium (EMC). Available from: http://www.medicines.org.uk/emc/medicine/10039/SPC/Spiriva+18+microgram+inhalation+powder%2c+hard+capsule/. Accessed July 19, 2013.
11. Boehringer Ingelheim. Spiriva Respimat 2.5 microgram solution for inhalation. Summary of Product Characteristics (SPC), Electonic Medicines Compendium (EMC). Available from: http://www.medicines.org.uk/emc/medicine/20134/SPC. Accessed July 19, 2013.
12. 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: 1460–1472.
13. Ichinose M, Fujimoto T, Fukuchi Y. Tiotropium 5microg via Respimat and 18microg via HandiHaler; efficacy and safety in Japanese COPD patients. Respir Med. 2010;104:228–236.
14. 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;103:22–29.
15. 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(4):405–414.
16. Boehringer Ingelheim. Boehringer Ingelheim submits appli cation in Europe to extend the indication for the use of tiotropium Respimat® to the treatment of asthma in adults aged 18 years and over [press release archive: asthma]. Ingelheim, Germany: Boehringer Ingelheim; 2013 [November 13]. Available from: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/13_november_2013_tiotropium.html. Accessed December 15, 2014.
17. Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP; UPLIFT Study Investigators. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180:948–955.
18. Boehringer Ingelheim. Tiotropium (Spiriva) Respimat: evaluation of fatal events. Ingelheim, Germany: Boehringer Ingelheim. Available from: 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. Accessed January 30, 2014.
19. 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.
20. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;7: CD009285.
21. Loke YK, Singh S. Risks associated with tiotropium in chronic obstructive pulmonary disease: overview of the evidence to date. Ther Adv Drug Safe. 2012;3:123–131.
22. 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.
23. Barr RG, Bourbeau J, Camargo CA, Ram FS. Tiotropium for stable chronic obstructive pulmonary disease: a meta-analysis. Thorax. 2006; 61:854–862.
24. 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.
25. Kesten S, Jara M, Wentworth C, Lanes S. Pooled clinical trial analysis of tiotropium safety. Chest. 2006;130:1695–1703.
26. Kesten S, Celli B, Decramer M, Leimer I, Tashkin D. Tiotropium HandiHaler in the treatment of COPD: a safety review. Int J Chron Obstruct Pulmon Dis. 2009;4:397–409.
27. Rodrigo GJ, Castro-Rodriguez JA, Nannini LJ, Plaza 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;103:1421–1429.
28. Salpeter SR. Do inhaled anticholinergics increase or decrease the risk of major cardiovascular events?: a synthesis of the available evidence. Drugs. 2009;69:2025–2033.
29. Wise RA, Anzueto A, Cotton D, et al; TIOSPIR Investigators. Tiotro-pium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369:1491–1501.
30. ICH harmonised tripartite guidelines. Clinical safety data management: definitions and standards for expidited reporting E2A. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; October 27; 1994.
31. Tashkin DP, Metzdorf N, Hallman C, Koenen-Bergmann M, Kupas K, Dahl R. Safety of tiotropium in renally impaired patients. Eur Respir J. 2014;44(Suppl 58): Abstract 923.
32. Jenkins CR. More than just reassurance on tiotropium safety. N Engl J Med. 2013;369(16):1555–1556.
33. Lee TA, Pickard AS, Au DH, Bartle B, Weiss KB. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med. 2008;149:380–390.
34. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2008;300:1439–1450.
35. Voshaar T, Lapidus R, Maleki-Yazdi R, et al. A randomized study of tiotropium Respimat Soft Mist inhaler vs ipratropium pMDI in COPD. Respir Med. 2008;102:32–41.
36. 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.
37. Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA; INSPIRE Investigators. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/futicasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177: 19–26.
38. Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs. 2012;72:273–300.
39. Church A, Beerahee M, Brooks J, Mehta R, Shah P. Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study. BMC Pulm Med. 2014;14:2.
40. Wedzicha JA, Decramer M, Ficker JH, 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.
41. Shavelle RM, Paculdo DR, Kush SJ, Mannino DM, Strauss DJ. Life expectancy and years of life lost in chronic obstructive pulmonary disease: findings from the NHANES III follow-up study. Int J Chron Obstruct Pulmon Dis. 2009;4:137–148.
42. Mannino DM, Doherty DE, Buist SA. Global initiative on obstructive lung disease (GOLD) classification of lung disease and mortality: findings from the Atherosclerosis Risk in Communities (ARIC) study. Respir Med. 2006;100:115–122.
43. Calverley PM, Lee A, Towse L, van Noord J, Witek TJ, Kelsen S. Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax. 2003;58: 855–860.
44. McNicholas WT, Calverley PM, Lee A, Edwards JC. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD. Eur Respir J. 2004;23:825–831.
45. Donohue JF, van Noord JA, Bateman ED, 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.
46. O’Donnell DE, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinfation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23:832–840.
47. Verkindre C, Bart F, Aguilaniu B, et al. The effect of tiotropium on hyperinfation and exercise capacity in chronic obstructive pulmonary disease. Respiration. 2006;73:420–427.
48. Celli B, ZuWallack R, Wang S, Kesten S. Improvement in resting inspiratory capacity and hyperinfation with tiotropium in COPD patients with increased static lung volumes. Chest. 2003;124:1743–1748.
49. Maltais F, Hamilton A, Marciniuk D, et al. Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD. Chest. 2005;128:1168–1178.
50. Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005;127:809–817.
51. Ambrosino N, Foglio K, Balzano G, Paggiaro PL, Lessi P, Kesten S; Tiotropium Multicentric Italian Study Group. Tiotropium and exercise training in COPD patients: effects on dyspnea and exercise tolerance. Int J Chron Obstruct Pulmon Dis. 2008;3:771–780.
52. Tonnel AB, Perez T, Grosbois JM, Verkindre C, Bravo ML, Brun M; TIPHON study group. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. Int J Chron Obstruct Pulmon Dis. 2008;3:301–310.
53. Beeh KM, Beier J, Buhl R, Stark-Lorenzen P, Gerken F, Metzdorf N; ATEM-Studiegruppe. Efficacy of tiotropium bromide (Spiriva) in patients with chronic-obstructive pulmonary disease (COPD) of different severities. Pneumologie. 2006;60:341–346.
54. Chan CK, Maltais F, Sigouin C, Haddon JM, Ford GT; SAFE Study Group. A randomized controlled trial to assess the efficacy of tiotropium in Canadian patients with chronic obstructive pulmonary disease. Can Respir J. 2007;14:465–472.
55. Powrie DJ, Wilkinson TM, Donaldson GC, et al. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. Eur Respir J. 2007;30:472–478.
56. Freeman D, Lee A, Price D. Efficacy and safety of tiotropium in COPD patients in primary care–the SPiRiva Usual CarE (SPRUCE) study. Respir Res. 2007;8:45.
57. Johansson G, Lindberg A, Romberg K, Nordstrom L, Gerken F, Roquet A. Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD. Prim Care Respir J. 2008;17:169–175.
58. Moita J, Barbara C, Cardoso J, et al. Tiotropium improves FEV1 in patients with COPD irrespective of smoking status. Pulm Pharmacol Ther. 2008;21:146–151.
59. 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;25:1708–1718.
60. Criner GJ, Sharafkhaneh A, Player R, et al. Efficacy of tiotropium inhalation powder in african-american patients with chronic obstructive pulmonary disease. COPD. 2008;5:35–41.
61. Magnussen H, Bugnas B, van NJ, Schmidt P, Gerken F, Kesten S. Improvements with tiotropium in COPD patients with concomitant asthma. Respir Med. 2008;102:50–56.
62. Sciurba FC, Siafakas N, Troosters T, et al. The efficacy of safety of tiotropium HandiHaler®, 18 ìg, once daily plys prn salbutamol versus placebo plus prn salbutamolin COPD subjects naïve to maintenance therapy. American Thoracic Society International Conference; 2011 May 13–18; Denver, CO; Abstract 21005.
63. 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;144:490–497.
64. Littner MR, van NJ, Moroni-Zentgraf P, Sigmund R, Joseph E, Karpel J. Phase IIB dose-finding study of BEA2180 via Respimat® in patients with chronic obstructive pulmonary disease (COPD). Respirology. 2012;17 (Suppl 2):44.
65. Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013;107:854–862.