nach oben

Drugs

Erschienen in:

01.10.2014 | Adis Drug Evaluation

Tiotropium Respimat^® Soft Mist™ Inhaler: A Review of Its Use in Chronic Obstructive Pulmonary Disease

verfasst von: Gillian M. Keating

Erschienen in: Drugs | Ausgabe 15/2014

Einloggen, um Zugang zu erhalten

Abstract

The long-acting anticholinergic agent tiotropium bromide (Spiriva^®) is available as a solution for inhalation via Respimat^® Soft Mist™ Inhaler in the EU and various other countries for the treatment of chronic obstructive pulmonary disease (COPD). With the Respimat^® Soft Mist™ Inhaler there is improved lung deposition of drug (allowing a reduced dosage compared with tiotropium HandiHaler^®), the delivered drug dose is independent of inspiratory effort and the prolonged duration of the aerosol cloud should make the co-ordination of actuation and inhalation easier. In patients with COPD, tiotropium Respimat^® improved lung function, COPD exacerbations, health-related quality of life and dyspnoea and was at least as effective as tiotropium HandiHaler^®. Tiotropium Respimat^® was generally well tolerated in patients with COPD, with anticholinergic adverse events among the most commonly reported adverse events. In the TIOSPIR trial, tiotropium Respimat^® was noninferior to tiotropium HandiHaler^® in terms of all-cause mortality, and the risk of cardiovascular mortality or major adverse cardiovascular events did not significantly differ between the two treatment groups. In conclusion, tiotropium Respimat^® Soft Mist™ Inhaler is a useful option for the treatment of patients with COPD.

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: updated 2014. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html (2014). Accessed 22 Sep 2014.

Barnes PJ. The pharmacological properties of tiotropium. Chest. 2000;117(2 Suppl):63S–6S.PubMedCrossRef

Boehringer Ingelheim Limited. Spiriva (tiotropium) Respimat 2.5 micrograms, solution for inhalation: UK summary of product characteristics. 2014. http://www.medicines.org.uk/emc/medicine/20134/SPC/Spiriva+Respimat+2.5+micrograms+solution+for+inhalation/. Accessed 22 Sep 2014.

Boehringer Ingelheim Limited. Spiriva (tiotropium) 18 microgram inhalation powder, hard capsule: UK summary of product characteristics. 2013. http://www.medicines.org.uk/emc/medicine/10039. Accessed 22 Sep 2014.

Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs. 2012;72(2):273–300.PubMedCrossRef

Dalby R, Spallek M, Voshaar T. A review of the development of Respimat^® Soft Mist™ Inhaler. Int J Pharm. 2004;283(1–2):1–9.PubMedCrossRef

Zierenberg B. Optimizing the in vitro performance of Respimat. J Aerosol Med. 1999;12(Suppl 1):S19–24.PubMed

Hochrainer D, Hölz H, Kreher C, et al. Comparison of the aerosol velocity and spray duration of Respimat^® Soft Mist™ inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005;18(3):273–82.PubMedCrossRef

Pitcairn G, Reader S, Pavia D, et al. 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(3):264–72.PubMedCrossRef

10.

Newman SP, Steed KP, Reader SJ, et al. Efficient delivery to the lungs of flunisolide aerosol from a new portable hand-held multidose nebulizer. J Pharm Sci. 1996;85(9):960–4.PubMedCrossRef

11.

Newman SP, Steed KP, Reader SJ, et al. An in vitro study to assess facial and ocular deposition from Respimat^® Soft Mist™ inhaler. J Aerosol Med. 2007;20(1):7–12.PubMedCrossRef

12.

Medicines Evaluation Board. Public assessment report of the Medicines Evaluation Board in the Netherlands: Spiriva (tiotropium) Respimat 2.5 microgram, solution for inhalation. 2011. http://www.cbg-meb.nl/CBG/en/human-medicines/geneesmiddeleninformatiebank/default.htm. Accessed 22 Sep 2014.

13.

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):457–64.PubMedCrossRef

14.

Haddad E-B, Mak JCW, Barnes PJ. Characterization of [³H]Ba 679 BR, a slowly dissociating muscarinic antagonist, in human lung: radioligand binding and autoradiographic mapping. Mol Pharmacol. 1994;45(5):899–907.PubMed

15.

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

16.

Tautermann CS, Kiechle T, Seeliger D, et al. Molecular basis for the long duration of action and kinetic selectivity of tiotropium for the muscarinic M3 receptor. J Med Chem. 2013;56(21):8746–56.PubMedCrossRef

17.

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;150(6 Pt 1):1640–5.PubMedCrossRef

18.

Sykes DA, Dowling MR, Leighton-Davies J, et al. The influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropium. J Pharmacol Exp Ther. 2012;343(2):520–8.PubMedCrossRef

19.

van Noord JA, Cornelissen PJG, Aumann J-L, et al. The efficacy of tiotropium administered via Respimat^® Soft Mist Inhaler™ or HandiHaler^® in COPD patients. Respir Med. 2009;103(1):22–9.PubMedCrossRef

20.

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(1):32–41.PubMedCrossRef

21.

Ichinose M, Fujimoto T, Fukuchi Y. Tiotropium 5 μg via Respimat and 18 μg via HandiHaler; efficacy and safety in Japanese COPD patients. Respir Med. 2010;104(2):228–36.PubMedCrossRef

22.

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):405–14.PubMedCrossRef

23.

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.PubMedPubMedCentral

24.

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(10):1460–72.PubMedCrossRef

25.

Feifel U, Wallenstein G, Rominger K-L, et al. Pharmacokinetics and tolerability (study 1) with particular reference to ocular safety (study 2) of tiotropium Respimat^® Soft Mist Inhaler™: findings from two dose-ranging studies in healthy men. Int J Chron Obstruct Pulmon Dis. 2008;3(3):397–403.PubMedPubMedCentral

26.

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):781–9.PubMedPubMedCentral

27.

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;5:277–86.PubMedCrossRefPubMedCentral

28.

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;30(3):472–8.PubMedCrossRef

29.

Holownia A, Mroz RM, Skopinski T, et al. Tiotropium increases PPARγ and decreases CREB in cells isolated from induced sputum of COPD patients. Adv Exp Med Biol. 2013;756:9–14.PubMedCrossRef

30.

Caillaud D, Le Merre C, Martinat Y, et al. A dose-ranging study of tiotropium delivered via Respimat^® Soft Mist Inhaler™ or HandiHaler^® in COPD patients. Int J Chron Obstruct Pulmon Dis. 2007;2(4):559–65.PubMedPubMedCentral

31.

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):117–22.PubMedCrossRef

32.

Sharma A, Hohlfeld J, Cornelissen PJG, et al. Comparison of the pharmacokinetics and pharmacodynamics of once daily tiotropium Respimat^® and tiotropium HandiHaler^® in COPD patients [slide presentation]. In: European Respiratory Society Annual Congress 2013; 7–11 Sep 2013; Barcelona.

33.

Calverley P, Könen-Bergmann M, Metzdorf N, et al. Tiotropium Respimat^®: comparison of bronchodilator efficacy of 5- and 2.5-μg doses [abstract no. P924 plus poster]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

34.

Tang Y, Massey D, Zhong N-S. Evaluation of the efficacy and safety of tiotropium bromide (5 μg) inhaled via Respimat in Chinese patients with chronic obstructive pulmonary disease. Chin Med J. 2013;126(19):3603–7.PubMed

35.

Wise RA, Anzueto A, Cotton D, et al. Tiotropium respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491–501.PubMedCrossRef

36.

Rau-Berger H, Mitfessel H, Glaab T. Tiotropium Respimat^® improves physical functioning in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2010;5:367–73.PubMedCrossRefPubMedCentral

37.

Hodder R, Pavia D, Lee A, et al. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat^® Soft Mist™ Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245–51.PubMedCrossRefPubMedCentral

38.

Tashkin D, Metzdorf N, Hallmann C, et al. Safety of tiotropium in renally impaired patients [abstract no. P923 plus poster]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

39.

Hohlfeld JM, Furtwaengler A, Könen-Bergmann M, et al. Cardiac safety of tiotropium in patients with COPD: combined analysis of Holter-ECG data from four randomized clinical trials [abstract no. P284 plus poster]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

40.

Boehringer Ingelheim. Boehringer Ingelheim announces FDA approval of Spiriva^® Respimat^® (tiotropium bromide) inhalation spray for the maintenance treatment of COPD [media release]. 25 Sep 2014. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/09-25-14-boehringer-ingelheim-announces-fda-approval-spiriva-respimat-tiotropium-bromide-inhalation-spray-maintenance-treatment-copd.html.

41.

Data on file, Boehringer Ingelheim: 2014.

42.

Mathioudakis AG, Chatzimavridou-Grigoriadou V, Evangelopoulou E, et al. Comparative mortality risk of tiotropium administered via handihaler or respimat in COPD patients: are they equivalent? Pulm Pharmacol Ther. 2014;28(2):91–7.PubMedCrossRef

43.

US Food and Drug Administration. Early communication about an ongoing safety review of tiotropium (marketed as Spiriva HandiHaler). 2008. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070651.htm. Accessed 22 Sep 2014.

44.

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(12):1439–50.PubMedCrossRef

45.

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(15):1543–54.PubMedCrossRef

46.

US Food and Drug Administration. Follow-up to the October 2008 updated early communication about an ongoing safety review of tiotropium (marketed as Spiriva HandiHaler). 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm197429.htm. Accessed 22 Sep 2014.

47.

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;103(10):1421–9.PubMedCrossRef

48.

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

49.

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;4:397–409.PubMedCrossRefPubMedCentral

50.

Bateman ED. Tiotropium Respimat increases the risk of mortality: con. Eur Respir J. 2013;42(3):590–3.PubMedCrossRef

51.

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:d3215.PubMedCrossRefPubMedCentral

52.

Dong Y-H, Lin H-H, Shau W-Y, et al. 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(1):48–56.PubMedCrossRef

53.

Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;7: CD009285.

54.

Verhamme KMC, Afonso A, Romio S, et al. Use of tiotropium Respimat Soft Mist Inhaler versus HandiHaler and mortality in patients with COPD. Eur Respir J. 2013;42(3):606–15.PubMedCrossRef

55.

Disse B, 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 [letter]. 2011. http://www.bmj.com/content/342/bmj.d3215?tab=responses. Accessed 22 Sep 2014.

56.

Metzdorf N, Hallmann C, Disse B. Thorax editorial by Jenkins and Beasley related to tiotropium respimat [letter]. Thorax. 2013;68(8):782.PubMedCrossRef

57.

Barnes NC, Jones PW, Davis KJ. Safety of tiotropium through the Handihaler: why did meta-analyses and database studies appear to give a false alarm? Thorax. 2014;69(6):598–9.PubMedCrossRef

58.

European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC): PRAC minutes of the meeting on 2-5 December 2013. 2013. www.ema.europa.eu/docs/en_GB/document_library/Minutes/2014/01/WC500159614.pdf. Accessed 22 Sep 2014.

59.

European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC): minutes of the meeting on 5-8 May 2014. 2014. www.ema.europa.eu/docs/en_GB/document_library/Minutes/2014/06/WC500169468.pdf. Accessed 22 Sep 2014.

60.

Verhamme KMC, Van Blijderveen N, Sturkenboom MCJM. Tiotropium and the risk of death in COPD [letter]. N Engl J Med. 2014;370(5):481–2.PubMed

61.

Halpin D, Dahl R, Hallmann C, et al. Tiotropium Handihaler^® and Respimat^® in COPD: a safety analysis on pooled data [abstract]. In: American Thoracic Society 2014 International Conference; 16–21 May 2014; San Diego (CA).

62.

Dahl R, Schmidt H, Könen-Bergmann M, et al. Mixed treatment analysis comparing tiotropium HandiHaler^® and Respimat^® [abstract no. P925 plus poster]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

63.

Bateman ED. Improving inhaler use in COPD and the role of patient preference. Eur Respir Rev. 2005;14(96):85–8.CrossRef

64.

Anderson P. Use of Respimat^® Soft Mist™ Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006;1(3):251–9.PubMedPubMedCentral

65.

Fink JB, Colice GL, Hodder R. Inhaler devices for patients with COPD. COPD. 2013;10(4):523–35.PubMedCrossRef

66.

Beasley R. Tiotropium Respimat increases the risk of mortality: pro. Eur Respir J. 2013;42(3):584–9.PubMedCrossRef

67.

Asakura Y, Nishimura N, Maezawa K, et al. Effect of switching tiotropium HandiHaler^® to Respimat^® Soft Mist™ Inhaler in patients with COPD: the difference of adverse events and usability between inhaler devices. J Aerosol Med Pulm Drug Deliv. 2013;26(1):41–5.PubMedCrossRef

68.

Shah P, Dhurjon L, Metcalfe T, et al. Acute angle closure glaucoma associated with nebulised ipratropium bromide and salbutamol. BMJ. 1992;304(6818):40–1.PubMedCrossRefPubMedCentral

69.

Oksuz H, Tamer C, Akoglu S, et al. Acute angle-closure glaucoma precipitated by local tiotropium absorption. Pulm Pharmacol Ther. 2007;20(6):627–8.PubMedCrossRef

70.

Hall SK. Acute angle-closure glaucoma as a complication of combined beta-agonist and ipratropium bromide therapy in the emergency department. Ann Emerg Med. 1994;23(4):884–7.PubMedCrossRef

71.

Boehringer Ingelheim. Tiotropium + olodaterol fixed dose combination (FDC) in chronic obstructive pulmonary disease (OTEMTO 2) [ClinicalTrials.gov identifier NCT02006732] US National Institutes of Health, ClinicalTrials.gov. 2014. http://www.clinicaltrials.gov/ct2/show/NCT02006732. Accessed 22 Sep 2014.

72.

Boehringer Ingelheim. Tiotropium + olodaterol fixed dose combination (FDC) in chronic obstructive pulmonary disease (OTEMTO 1) [ClinicalTrials.gov identifier NCT01964352] US National Institutes of Health, ClinicalTrials.gov. 2014. http://www.clinicaltrials.gov/ct2/show/NCT01964352. Accessed 22 Sep 2014.

73.

Derom E, Westerman J, Grönke L, et al. The 24-hour lung function profile of once-daily tiotropium and olodaterol fixed-dose combination compared with placebo and monotherapies in chronic obstructive pulmonary disease (VIVACITO) [poster]. In: American Thoracic Society International Conference; 16–21 May 2014; San Diego (CA).

74.

Buhl R, Derom E, Ferguson G, et al. Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat improves ouctomes vs monocomponents in COPD in two 1-year studies [abstract no. 1895]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

75.

Buhl R, Abrahams R, Bjermer L, et al. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat^® in chronic obstructive pulmonary disease in two 1-year studies [poster]. In: European Respiratory Society International Congress 2014; 6–10 Sep 2014; Munich.

76.

Yohannes AM, Connolly MJ, Hanania NA. Ten years of tiotropium: clinical impact and patient perspectives. Int J Chron Obstruct Pulmon Dis. 2013;8:117–25.PubMedCrossRefPubMedCentral

Titel: Tiotropium Respimat® Soft Mist™ Inhaler: A Review of Its Use in Chronic Obstructive Pulmonary Disease
verfasst von: Gillian M. Keating
Publikationsdatum: 01.10.2014
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 15/2014
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-014-0307-4

Springer Medizin

Abstract

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

Weitere Artikel der Ausgabe 15/2014

Systemic Glucocorticoid Therapy: a Review of its Metabolic and Cardiovascular Adverse Events

Eliglustat: First Global Approval

Management of Non-Transfusion-Dependent Thalassemia: A Practical Guide

Albumin-Bound Paclitaxel: A Review of Its Use for the First-Line Combination Treatment of Metastatic Pancreatic Cancer

Suvorexant: First Global Approval

Dabigatran Etexilate: A Review of Its Use in the Treatment of Acute Venous Thromboembolism and Prevention of Venous Thromboembolism Recurrence