nach oben

Drugs

Erschienen in:

01.01.2012 | Adis Drug Evaluation

Tiotropium Bromide Inhalation Powder

A Review of its Use in the Management of Chronic Obstructive Pulmonary Disease

verfasst von: Gillian M. Keating

Erschienen in: Drugs | Ausgabe 2/2012

Einloggen, um Zugang zu erhalten

Abstract

The anticholinergic agent tiotropium bromide (Spiriva®) is a long-acting bronchodilator that is indicated for the treatment of chronic obstructive pulmonary disease (COPD). This article reviews the clinical efficacy and tolerability of tiotropium bromide inhalation powder, administered using the HandiHaler® device, in patients with COPD, as well as reviewing its pharmacological properties and the results of pharmacoeconomic analyses.

Shorter-term placebo-controlled trials in patients with COPD demonstrated significantly higher trough forced expiratory volume in 1 second (FEV₁) responses with tiotropium bromide than with placebo, confirming it has a duration of action of ≥24 hours and is suitable for once-daily administration. Lung function improved to a greater extent with tiotropium bromide than with ipratropium bromide or, in most instances, salmeterol. Indacaterol was shown to be non-inferior to tiotropium bromide in terms of the trough FEV₁ response.

The large, 4-year UPLIFT® trial did not show a significant reduction in the annual rate of decline in FEV₁ with tiotropium bromide versus placebo in patients with COPD, although subgroup analyses demonstrated a significantly lower rate of decline with tiotropium bromide than with placebo in some patient groups (e.g. patients with moderate COPD, patients aged ≥50 years, patients not receiving maintenance therapy at baseline).

Tiotropium bromide prevented exacerbations in patients with COPD, with a s3333ignificantly lower exacerbation rate and a significantly longer time to first exacerbation seen with tiotropium bromide than with placebo or salmeterol. Exacerbation rates did not significantly differ between patients receiving tiotropium bromide and those receiving salmeterol/fluticasone propionate. Tiotropium bromide also had beneficial effects on health-related quality of life (HR-QOL) and other endpoints, such as dyspnoea and rescue medication use.

Combination therapy with tiotropium bromide plus formoterol with or without budesonide improved lung function to a significantly greater extent than tiotropium bromide alone in patients with COPD. In addition, exacerbation rates were lower and HR-QOL was improved with tiotropium bromide plus budesonide/formoterol versus tiotropium bromide alone. Although the addition of salmeterol/fluticasone propionate to tiotropium bromide did not reduce the COPD exacerbation rate, it did improve lung function and HR-QOL.

Tiotropium bromide inhalation powder is generally well tolerated in patients with COPD, with anticholinergic adverse events (e.g. dry mouth, constipation, gastrointestinal obstruction, dysuria) among the most commonly reported adverse events. The UPLIFT® trial showed no significant difference between tiotropium bromide and placebo recipients in the risk of stroke, and the risk of serious cardiac adverse events (including congestive heart failure and myocardial infarction) was significantly lower with tiotropium bromide than with placebo. The absence of a detrimental effect on cardiovascular outcomes was supported by the results of a meta-analysis and pooled analyses. In addition, on-treatment mortality was lower with tiotropium bromide than with placebo in the UPLIFT® trial. Pooled analyses showed significantly lower cardiovascular mortality with tiotropium bromide than with placebo, with a meta-analysis demonstrating no significant difference between patients receiving tiotropium bromide and controls in cardiovascular mortality.

Results of modelled pharmacoeconomic analyses conducted from a healthcare payer perspective in several developed countries suggest that tiotropium bromide is a cost-effective option in patients with COPD.

In conclusion, tiotropium bromide inhalation powder is a useful option for the maintenance treatment of patients with COPD.

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, managment, and prevention of chronic obstructive pulmonary disease (updated 2010) [online]. Available from URL: http://www.goldcopd.org/uploads/users/files/GOLDReport_Apri112011.pdf [Accessed 2011 Oct 14]

Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011 Aug 2; 155(3): 179–91PubMedCrossRef

Barnes PJ. The pharmacological properties of tiotropium. Chest 2000 Feb; 117 (2 Suppl.): 63–66SCrossRef

Disse B, Speck GA, Rominger KL, et al. Tiotropium (Spiriva™): mechanistical considerations and clinical profile in obstructive lung disease. Life Sci 1999; 64(6–7): 457–64PubMedCrossRef

Haddad E-B, Mak JCW, Barnes PJ. Characterization of [³H]Ba 679 BR, a slowly dissociating muscarinic antagonist, in human lung: radioligand binding and auto-radiographic mapping. Mol Pharmacol 1994 May; 45: 899–907PubMed

Disse B, Reichl R, Speck G, et al. BA 679 BR, a novel long-acting anticholinergic bronchodilator. Life Sci 1993; 52(5-6): 537–44PubMedCrossRef

Boehringer Ingelheim International GmbH. Spiriva® 18 microgram inhalation powder, hard capsule: UK summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/EMC/medicine/10039/SPC/Spiriva+18+microgram+inhalation+powder%2c+hard+capsule/ [Accessed 2011 Sep 30]

Bateman ED, Rennard S, Barnes PJ, et al. Alternative mechanisms for tiotropium. Pulm Pharmacol Ther 2009; 22(6): 533–42PubMedCrossRef

Takahashi T, Belvisi MG, Patel H, et al. Effect of Ba 679 BR, a novel long-acting anticholinergic agent, on cholinergic neurotransmission in guinea pig and human airways. Am J Respir Crit Care Med 1994 Dec; 150 (6 Pt 1): 1640–5PubMedCrossRef

10.

Maesen FPV, Smeets JJ, Sledsens TJH, et al. Tiotropium bromide, a new long-acting antimuscarinic bronchodilator: a pharmacodynamic study in patients with chronic obstructive pulmonary disease (COPD). Eur Respir J 1995 Sep; 8(9): 1506–13PubMed

11.

Calverley PMA, Lee A, Towse L, et al. Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax 2003 Oct; 58(10): 855–60PubMedCentralPubMedCrossRef

12.

Cazzola M, Di Marco F, Santus P, et al. The pharmacodynamic effects of single inhaled doses of formoterol, tiotropium and their combination in patients with COPD. Pulm Pharmacol Ther 2004; 17(1): 35–9PubMedCrossRef

13.

Littner MR, Ilowite JS, Tashkin DP, et al. Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000; 161(4 I): 1136–42PubMedCrossRef

14.

van Noord JA, Smeets JJ, Custers FL, et al. Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. Eur Respir J 2002 Apr; 19(4): 639–44PubMedCrossRef

15.

van Noord JA, Bantje TA, Eland ME, et al. A randomised controlled comparison of tiotropium and ipratropium in the treatment of chronic obstructive pulmonary disease. Thorax 2000 Apr; 55(4): 289–94PubMedCentralPubMedCrossRef

16.

Casaburi R, Briggs DD, Donohue JF, et al. The spirometric efficacy of once-daily dosing with tiotropium in stable COPD: a 13-week multicenter trial. Chest 2000 Nov; 118(5): 1294–302PubMedCrossRef

17.

Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003 Nov; 124(5): 1743–8PubMedCrossRef

18.

O’Donnell DE, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004 Jun; 23(6): 832–40PubMedCrossRef

19.

Verkindre C, Bart F, Aguilaniu B, et al. The effect of tiotropium on hyperinflation and exercise capacity in chronic obstructive pulmonary disease. Respiration 2006; 73(4): 420–7PubMedCrossRef

20.

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 Sep; 128(3): 1168–78PubMedCrossRef

21.

Berton DC, Reis M, Siqueira ACB, et al. Effects of tiotropium and formoterol on dynamic hyperinflation and exercise endurance in COPD. Respir Med 2010 Sep; 104(9): 1288–96PubMedCrossRef

22.

Bédard M-E, Brouillard C, Pepin V, et al. Tiotropium improves walking endurance in chronic obstructive pulmonary disease. Eur Respir J. Epub 2011 Jun 23

23.

Legg D, Cooper CB, Celli B, et al. Treadmill endurance during 2 years treatment with tiotropium in patients with COPD [abstract]. 107th International Conference of the American Thoracic Society; 2011 May 13–18; Denver (CO)

24.

Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005 Mar; 127(3): 809–17PubMedCrossRef

25.

Kesten S, Casaburi R, Kukafka D, et al. Improvement in self-reported exercise participation with the combination of tiotropium and rehabilitative exercise training in COPD patients. Int J Chron Obstruct Pulmon Dis 2008; 3(1): 127–36PubMedCentralPubMed

26.

Ambrosino N, Foglio K, Balzano G, et al. Tiotropium and exercise training in COPD patients: effects on dyspnea and exercise tolerance. Int J Chron Obstruct Pulmon Dis 2008; 3(4): 771–80PubMedCentralPubMed

27.

Incorvaia C, Riario-Sforza GG, Pravettoni C, et al. Impairment of small airways in COPD patients with frequent exacerbations and effects of treatment with tiotropium. Int J Chron Obstruct Pulmon Dis 2008; 3(1): 123–6PubMedCentralPubMed

28.

Incorvaia C, Riario-Sforza GG, Pravettoni C, et al. Effects of replacing oxitropium with tiotropium on pulmonary function in patients with COPD: a randomized study. Respir Med 2007 Mar; 101(3): 476–80PubMedCrossRef

29.

Asano K, Shikama Y, Shoji N, et al. Tiotropium bromide inhibits TGF-β-induced MMP production from lung fibroblasts by interfering with Smad and MAPK pathways in vitro. Int J Chron Obstruct Pulmon Dis 2010; 5: 277–86PubMedCentralPubMedCrossRef

30.

Asano K, Shikama Y, Shibuya Y, et al. Suppressive activity of tiotropium bromide on matrix metalloproteinase production from lung fibroblasts in vitro. Int J Chron Obstruct Pulmon Dis 2008; 3(4): 781–9PubMedCentralPubMed

31.

Powrie DJ, Wilkinson TMA, Donaldson GC, et al. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. Eur Respir J 2007 Sep; 30(3): 472–8PubMedCrossRef

32.

Hasani A, Toms N, Agnew JE, et al. The effect of inhaled tiotropium bromide on lung mucociliary clearance in patients with COPD. Chest 2004 May; 125(5): 1726–34PubMedCrossRef

33.

Covelli H, Bhattacharya S, Cassino C, et al. Absence of electrocardiographic findings and improved function with once-daily tiotropium in patients with chronic obstructive pulmonary disease. Pharmacotherapy 2005 Dec; 25(12): 1708–18PubMedCrossRef

34.

Boehringer Ingelheim International GmbH. Spiriva® Handihaler® (tiotropium bromide inhalation powder): US prescribing information [online]. Available from URL:http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf [Accessed 2011 Sep 30]

35.

Nakanishi T, Haruta T, Shirasaka Y, et al. Organic cation transporter-mediated renal secretion of ipratropium and tiotropium in rats and humans. Drug Metab Dispos 2011; 39(1): 117–22PubMedCrossRef

36.

Türck D, Weber W, Sigmund R, et al. Pharmacokinetics of intravenous, single-dose tiotropium in subjects with different degrees of renal impairment. J Clin Pharmacol 2004 Feb; 44(2): 163–72PubMedCrossRef

37.

Chan CKN, Maltais F, Sigouin C, et al. A randomized controlled trial to assess the efficacy of tiotropium in Canadian patients with chronic obstructive pulmonary disease. Can Respir J 2007 Nov/Dec; 14(8): 465–72PubMedCentralPubMed

38.

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: 45PubMedCentralPubMedCrossRef

39.

Johansson G, Lindberg A, Romberg K, et al. Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD. Prim Care Respir J 2008 Sep; 17(3): 169–75PubMedCrossRef

40.

Moita J, Bárbara C, Cardoso J, et al. Tiotropium improves FEV1 in patients with COPD irrespective of smoking status. Pulm Pharmacol Ther 2008; 21(1): 146–51PubMedCrossRef

41.

Sciurba FC, Siafakas N, Troosters T, et al. The efficacy and safety of tiotropium HandiHaler, 18 µg, once daily plus PRN salbutamol in COPD subjects naive to maintenance therapy [abstract]. 107th International Conference of the American Thoracic Society; 2011 May 13–18; Denver (CO)

42.

Briggs DD, Covelli H, Lapidus R, et al. Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD. Pulm Pharmacol Ther 2005; 18(6): 397–404PubMedCrossRef

43.

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(1): 47–55PubMedCrossRef

44.

Buhl R, Dunn LJ, Disdier C, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J 2011 Oct; 38(4): 797–803PubMedCrossRef

45.

Rabe KF, Timmer W, Sagkriotis A, et al. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest 2008 Aug; 134(2): 255–62PubMedCrossRef

46.

Tashkin DP, Pearle J, Iezzoni D, et al. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009 Feb; 6(1): 17–25PubMedCrossRef

47.

Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009 Oct 15; 180(8): 741–50PubMedCrossRef

48.

Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008 Oct 9; 359(15): 1543–54PubMedCrossRef

49.

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 Sep 6; 143(5): 317–26PubMedCrossRef

50.

Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011 Mar 24; 364(12): 1093–103PubMedCrossRef

51.

Wedzicha JA, Calverley PMA, Seemungal TA, et al. 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): 19–26PubMedCrossRef

52.

Aaron SD, Vandemheen KL, Fergusson D, et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2007 Apr 17; 146(8): 545–55PubMedCrossRef

53.

Tonnel A-B, Perez T, Grosbois J-M, et al. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. Int J Chron Obstruct Pulmon Dis 2008; 3(2): 301–10PubMedCentralPubMed

54.

Center for Drug Evaluation and Research. Application number: 21-396. Medical review(s) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395.pdf_Spiriva_Medr_P1.pdf [Accessed 2011 Oct 4]

55.

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 Feb; 19(2): 217–24PubMedCrossRef

56.

Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003 May; 58(5): 399–404PubMedCentralPubMedCrossRef

57.

Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 yr’s treatment with tiotropium. Eur Respir J 2002 Feb; 19(2): 209–16PubMedCrossRef

58.

Boehringer Ingelheim Pharmaceuticals. Trial comparing tiotropium inhalation capsules vs placebo in chronic obstructive pulmonary disease (COPD) [ClinicalTrials.gov identifier NCT00523991]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2011 Oct 18]

59.

Adams SG, Anzueto A, Briggs DD, et al. Evaluation of withdrawal of maintenance tiotropium in COPD. Respir Med 2009 Oct; 103(10): 1415–20PubMedCrossRef

60.

Donohue JF, Menjoge S, Kesten S. Tolerance to bronchodilating effects of salmeterol in COPD. Respir Med 2003 Sep; 97(9): 1014–20PubMedCrossRef

61.

Tashkin DP, Varghese ST. Combined treatment with formoterol and tiotropium is more efficacious than treatment with tiotropium alone in patients with chronic obstructive pulmonary disease, regardless of smoking status, inhaled corticosteroid use, baseline severity, or gender. Pulm Pharmacol Ther 2011 Feb; 24(1): 147–52PubMedCrossRef

62.

Tashkin D, Celli B, Kesten S, et al. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respir Med 2010 Oct; 104(10): 1495–504PubMedCrossRef

63.

Tashkin DP, Celli B, Kesten S, et al. Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial. Eur Respir J 2010 Feb; 35(2): 287–94PubMedCrossRef

64.

Fukuchi Y, Fernandez L, Kuo H-P, et al. Efficacy of tiotropium in COPD patients from Asia: a subgroup analysis from the UPLIFT trial. Respirology 2011 Jul; 16(5): 825–35PubMedCrossRef

65.

Decramer M, Celli B, Kesten S, et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009 Oct 3; 374(9696): 1171–8PubMedCrossRef

66.

Morice AH, Celli B, Kesten S, et al. COPD in young patients: a pre-specified analysis of the four-year trial of tiotropium (UPLIFT). Respir Med 2010 Nov; 104(11): 1659–67PubMedCrossRef

67.

Troosters T, Celli B, Lystig T, et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J 2010 Jul; 36(1): 65–73PubMedCrossRef

68.

Cooper CB, Anzueto A, Decramer M, et al. Tiotropium reduces risk of exacerbations irrespective of previous use of inhaled anticholinergics in placebo-controlled clinical trials. Int J Chron Obstruct Pulmon Dis 2011; 6: 269–75PubMedCentralPubMedCrossRef

69.

Dusser D, Bravo ML, Iacono P. The effect of tiotropium on exacerbations and airflow in patients with COPD. Eur Respir J 2006 Mar; 27(3): 547–55PubMedCrossRef

70.

Beeh KM, Vogelmeier C, Rutten-van Mölkem MPHH, et al. Tiotropium vs salmeterol in GOLD II and Maintenancenaïve COPD patients: subgroup analyses of POET-COPD™ trial [abstract no. P251]. 21st Annual Congress of the European Respiratory Society; 2011 Sep 24–28; Amsterdam

71.

Celli B, Decramer M, Kesten S, et al. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009 Nov 15; 180(10): 948–55PubMedCrossRef

72.

Rodrigo GJ, Castro-Rodriguez JA, Nannini LJ, et al. Tiotropium and risk for fatal and nonfatal cardiovascular events in patients with chronic obstructive pulmonary disease: systematic review with meta-analysis. Respir Med 2009 Oct; 103(10): 1421–9PubMedCrossRef

73.

Kesten S, Celli B, Decramer M, et al. Tiotropium HandiHaler® in the treatment of COPD: a safety review. Int J Chron Obstruct Pulmon Dis 2009; 4: 397–409PubMedCentralPubMedCrossRef

74.

Celli B, Decramer M, Leimer I, et al. Cardiovascular safety of tiotropium in patients with COPD. Chest 2010 Jan; 137(1): 20–30PubMedCrossRef

75.

Calverley PMA, Stockley RA, Seemungal TA, et al. Reported pneumonia in patients with COPD: findings from the INSPIRE study. Chest 2011 Mar; 139(3): 505–12PubMedCrossRef

76.

US Food and Drug Administration. Early communication about an ongoing safety review of tiotropium (marketed as Spiriva HandiHaler) [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070651.htm [Accessed 2011 Oct 13]

77.

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 Sep 24; 300(12): 1439–50PubMedCrossRef

78.

Gani R, Griffin J, Kelly S, et al. Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD. Prim Care Respir J 2010 Mar; 19(1): 68–74PubMedCrossRef

79.

Maniadakis N, Tzanakis N, Fragoulakis V, et al. Economic evaluation of tiotropium and salmeterol in the treatment of chronic obstructive pulmonary disease (COPD) in Greece. Curr Med Res Opin 2006 Aug; 22(8): 1599–607PubMedCrossRef

80.

Naik S, Kamal KM, Keys PA, et al. Evaluating the cost-effectiveness of tiotropium versus salmeterol in the treatment of chronic obstructive pulmonary disease. Clin Outcomes Res 2010; 2(1): 25–36

81.

Rutten-van Mölken MPMH, Oostenbrink JB, Miravitlles M, et al. Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain. Eur J Health Econ 2007 Jun; 8(2): 123–35PubMedCentralPubMedCrossRef

82.

Oostenbrink JB, Rutten-van Mölken MPMH, Monz BU, et al. Probabilistic Markov model to assess the cost-effectiveness of bronchodilator therapy in COPD patients in different countries. Value Health 2005 Jan–Feb; 8(1): 32–46PubMedCrossRef

83.

Rennard SI, Anderson W, ZuWallack R, et al. Use of a long-acting inhaled β2-adrenergic agonist, salmeterol xinafoate, in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001 Apr; 163(5): 1087–92PubMedCrossRef

84.

Mittmann N, Hernandez P, Mellström C, et al. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics 2011 May 1; 29(5): 403–14PubMedCrossRef

85.

Center for Drug Evaluation and Research. Approval letter: NDA 21-395 [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395ltr.pdf [Accessed 2011 Nov 30]

86.

Anthonisen NR, Connett JE, Kiley JP, et al. Effects of smoking intervention and the use of an inhaled anti-cholinergic bronchodilator on the rate of decline of FEV1: the Lung Health Study. JAMA 1994 Nov 16; 272(19): 1497–505PubMedCrossRef

87.

Celli BR, Thomas NE, Anderson JA, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med 2008 Aug 15; 178(4): 332–8PubMedCrossRef

88.

Decramer M, Molenberghs G, Liu D, et al. Premature discontinuation during the UPLIFT study. Respir Med 2011 Oct; 105(10): 1523–30PubMedCrossRef

89.

Tashkin DP. Preventing and managing exacerbations in COPD: critical appraisal of the role of tiotropium. Int J Chron Obstruct Pulmon Dis 2010; 5: 41–53PubMedCentralPubMedCrossRef

90.

Rabe KF. Anticholinergic drugs for the treatment of COPD are safe: are they? Chest 2010 Jan; 137(1): 1–3PubMedCrossRef

91.

Anthonisen NR, Connett JE, Enright PL, et al. Hospitalizations and mortality in the Lung Health Study. Am J Respir Crit Care Med 2002 Aug 1; 166(3): 333–9PubMedCrossRef

92.

Lee TA, Pickard AS, Au DH, et al. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med 2008 Sep 16; 149(6): 380–90PubMedCrossRef

93.

Michele TM, Pinheiro S, Iyasu S. The safety of tiotropium: the FDA’s conclusions. N Engl J Med 2010 Sep 16; 363(12): 1097–9PubMedCrossRef

94.

Lanes S, Golisch W, Mikl J. Ipratropium and lung health study [letter]. Am J Respir Crit Care Med 2003 Mar 1; 167(5): 801PubMedCrossRef

95.

Reilly JJ. COPD and declining FEV1: time to divide and conquer? N Engl J Med 2008 Oct 9; 359(15): 1616–8PubMedCrossRef

96.

Singh S, Loke YK, Enright PL, et al. 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: d3215PubMedCentralPubMedCrossRef

97.

Disse E, Metzdorf N, Martin A, et al. Mortality associated with tiotropium mist inhaler? A critical appraisal of the authors’ selection and use of previously communicated tiotropium Respimat data [online]. Available from URL: http://www.bmj.com/content/342/bmj.d3215?tab=responses [Accessed 2011 Nov 29]

98.

Boehringer Ingelheim Pharmaceuticals. Comparison of tiotropium in the HandhiHaler versus the Respimat in chronic obstructive pulmonary disease [ClinicalTrials.gov identifier NCT01126437]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2011 Oct 14]

99.

Boehringer Ingelheim GmbH. Boehringer Ingelheim/Pfizer position regarding the recent publication by Singh et al. in the British Medical Journal, June 15, 2011 [media release]. Available from URL: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2011/15_june_2011_copd.html [Accessed 2011 Oct 14]

100.

Cazzola M, Calzetta L, Matera MG. The cardiovascular risk of tiotropium: is it real? Expert Opin Drug Saf 2010 Sep; 9(5): 783–92PubMedCrossRef

101.

Peters SP, Kunselman SJ, Icitovic N, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med 2010 Oct 28; 363(18): 1715–26PubMedCentralPubMedCrossRef

Titel: Tiotropium Bromide Inhalation Powder
A Review of its Use in the Management of Chronic Obstructive Pulmonary Disease
verfasst von: Gillian M. Keating
Publikationsdatum: 01.01.2012
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 2/2012
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.2165/11208620-000000000-00000

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 2/2012

Pharmacotherapy for Breakthrough Cancer Pain

Are Proton Pump Inhibitors Safe during Pregnancy and Lactation?

Saxagliptin

Erratum to Pharmacotherapy for breakthrough cancer pain

Translating Comparative Effectiveness Research into Clinical Practice

Repaglinide