Safety and pharmacological profile of tiotropium bromide

Expert Opinion on Drug Safety

Volumn 8, Issue 3, 2009, Pages 387-395

  Santus, Pierachille ^a   Di Marco, Fabiano ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

Adverse events; COPD; Safety; Tiotropium

Indexed keywords

ACETYLCHOLINE; CYCLIC AMP; FORMOTEROL; MITOGEN ACTIVATED PROTEIN KINASE; MUSCARINIC M1 RECEPTOR; MUSCARINIC M2 RECEPTOR; MUSCARINIC M3 RECEPTOR; PLACEBO; SALMETEROL; TIOTROPIUM BROMIDE;

ABDOMINAL PAIN; ANGINA PECTORIS; ANGIONEUROTIC EDEMA; BRONCHODILATING ACTIVITY; CARDIOVASCULAR RISK; CENTRAL NERVOUS SYSTEM DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONNECTIVE TISSUE DISEASE; CONSTIPATION; DRUG BIOAVAILABILITY; DRUG HALF LIFE; DRUG SELECTIVITY; DYSPEPSIA; DYSPHAGIA; EDEMA; FORCED EXPIRATORY VOLUME; GLAUCOMA; HEART ATRIUM FIBRILLATION; HEART FAILURE; HEART INFARCTION; HUMAN; INSPIRATORY CAPACITY; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; MYCOSIS; NAUSEA; NONHUMAN; PATHOPHYSIOLOGY; PNEUMONIA; PROSTATE DISEASE; PRURITUS; RASH; RESPIRATORY FAILURE; REVIEW; STROKE; SYSTEMATIC REVIEW; THORAX PAIN; TREATMENT OUTCOME; URINE RETENTION; URTICARIA; VISUAL DISORDER; XEROSTOMIA;

ANIMALS; BRONCHODILATOR AGENTS; HUMANS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SCOPOLAMINE DERIVATIVES;

EID: 67649344809     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740330902953684     Document Type: Review

References (55)

1. Disse B, Reichel R, Speck GA, et al. Ba679 Br., a novel anticholinergic bronchodilator. Life Sci 1993;52:537-544 • One of first papers about tiotropium.
2. Takahaski T, Belvisi MG, Patel H, et al. Effect of BA679 Br, a novel long-acting anticholinergic agent, on cholinergic neurotransmission in guinea pig and human airways. Am J Respir crit Care Med 1994;150:1640-1645 • About effect of tiotropium on airways cholinergic system. (Pubitemid 24361740)
3. Disse B, Speck GA, Rominger KL, et al. Tiotropium (Spiriva™): mechanistical considerations and clinical profiler in obstructive lung disease. Life Sci 1999;64:457-464 (Pubitemid 29066693)
4. Maesen FVP, Smeets JJ, Costongs MAL, et al. Ba 679 Br, a new long-acting antimuscarinic bronchodilator: a pilot dose-scalation study in COPD. Eur Respir J 1993;6:1031-1036 (Pubitemid 23221340)
5. Dixon WE, Brodie TG. Contributions to the physiology of the lungs. Part I. The bronchial muscles, their innervation, and the action of drugs upon them. J Physiol 1903;29:97-173
6. Dixon WE, Ransom F. Broncho-dilator nerves. J Physiol 1912;45:413-428
7. Macklin CC. The musculature of the bronchi and lungs. Physiol Rev 1929;9:1-60
8. Widdicombe JG. Regulation of tracheobronchial smooth muscle. Physiol Rev 1963;43:1-37
9. Barnes PJ. Anticholinergic agents in the upper and lower airways. In: Spector SL, editor, Marcel Dekker, New York, Basel; 1999
10. Ward JK, Barnes PJ, Springall DR, et al. Distribution of human i-NANC bronchodilator and nitric oxide-immunoreactive nerves. Am J respir Cell Mol Biol 1995;13:175-184
11. Kummer W, Fischer A, Kurkowski R, et al. The sensory and sympathetic innervation of guinea pig lung and trachea as studied by retrograde neuronal tracing and double-labeling immunohistochemistry. Neuroscience 1988;74:265-274
12. Ind PW. Airways smooth muscle: structure, innervation and neurotrasmission. In: Raeburn D, Gymbiecz M, editors, Birkhauser Verlag, Basel; 1994
13. Fischer A, Hoffmann B. Nitric oxide synthase in neurons and nerve fibers of lower airways and in vagal sensory ganglia of man: correlation with neuropeptides. Am J Respir Crit Care Med 1996;154:209-216 (Pubitemid 26255791)
14. Cabezas GA, Graf PD, Nadel JA. Sympathetic versus parasympathetic nervous regulation of airways in dogs. J Appl Physiol 1971;31:651-655
15. Diamond L, O'Donnel M. A nonadrenergic vagal inhibitory pathway to feline airways. Science 1980;208(11):185-188 (Pubitemid 10072137)
16. Takahashi N, Tanaka H, Abdullah N, et al. Regional difference in the distribution of L-NAME-sensitive and -insensitive NANC relaxations in cat airway. J Physiol 1995;488:709-720
17. Canning BJ, Fischer A. Localization of cholinergic nerves in the airways of the guinea pig using antisera to choline acetyltransferase. Am J Physiol 1997;272:L731-8 (Pubitemid 27197845)
18. Barnes PJ. Neural control of human airways in health and disease. Am Rev Respir Dis 1986;134:1289-1314 •• A position paper about airways physiology. (Pubitemid 17216914)
19. Canning BJ, Undem BJ. Airways smooth muscle: structure, innervation and neurotrasmission. In: Raeburn D, Gymbiecz M, editors, Birkhauser Verlag, Basel; 1994
20. Dixon WE, Brodie TG. Contributions to the physiology of the lungs. Part I. The bronchial muscles, their innervation, and the action of drugs upon them. J Physiol 1903;29:97-173
21. Gross NJ. Antichilinergic drugs. Asthma vol. 2. Lippincott-Raven, Philadelphia, New York; 1997
22. Lee AM, Jacoby DB, Fryer AD. Selective muscarinic receptor antagonists for airway diseases. Curr Opin Pharmacol 2001;1:223-229 • A pharmacological issue on antagonist muscarinic ways. (Pubitemid 33585966)
23. Costello RW, Jacoby DB, Fryer AD. Pulmonary neuronal M" muscarinic receptor function in asthma and animal models of hyperreactivity. Thorax 1998;53:613-6
24. Peralta EG, Ashkenazi A, Winslow JW, et al. Differential regulation of PI hydrolysis and adenylyl cyclase by muscarinic receptor subtypes. Nature 1988;334:434-437 (Pubitemid 18188029)
25. Berkeley JL, Levey AI. Muscarinic activation of mitogen-activated protein Kinase in PC 12 cells. J Neurochem 2000;75:487-493 (Pubitemid 30485429)
26. Profita M, Di GIORGI, R SALA, et al. Muscarinic receptors, leukotriene B4 production and neutrophilic inflammation in COPD patients. Allergy 2005;60:1361-1369 (Pubitemid 41476178)
27. Haddad EB, 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;45:899-907
28. Spiriva HandiHaler [package insert]. Ridgefield, Conn: Boehringer Ingelheim Pharmaceuticals, Inc; 2004
29. Barnes PJ. The pharmacological properties of tiotropium. Chest 2000;117:635-665 • A review about pharmacology of tiotripium. (Pubitemid 30111568)
30. Turck 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;44:163-172 (Pubitemid 38114315)
31. Disse B, Rominger K, Serby CW, et al. The pharmacokinetic (PK) profilr of titotropium during long-term treatment in stable COPD [abstract]. Am J Respir Crit Care Med 1999;159:A524
32. Di Marco F, Verga M, Santus P, et al. Effect of formoterol, tiotropium and their combination in patients with acute exacerbation of chronic obstructive pulmonary disease: a pilot study. Respir Med 2006;100:1925-1932 (Pubitemid 44490293)
33. van Noord JA, Aumann JL, Janssens E, et al. Comaprison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005;26:214-222 (Pubitemid 41079064)
34. 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;8:1506-1513
35. 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;17:35-39 (Pubitemid 37468407)
36. McNicholas WT, Calverley PMA, Lee A, et al. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD. Eur Respir J 2004;23:825-831 (Pubitemid 38807354)
37. Santus P, Centanni S, Morelli N, et al. Tiotropium is likely to induce oxygen desaturation in stable COPD patients compared to long-acting b2-agonists. Respir Med 2007;101:1798-1803 (Pubitemid 46930701)
38. 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 •• A more recent clinical trial about tiotropium in a long-therapy study.
39. Kesten S, Jara M, Wentworth C, et al. Pooled clinical trial analysis of the safety of tiotropium. Chest 2006;130:1695-1703 •• Very interesting analysis on clinical safety of tiotropium. (Pubitemid 46033421)
40. 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 • For an interesting consideration after UPLIFT publication.
41. Early communication about an ongoing safety review of tiotropium (marketed as Spiriva HandiHaler). FDA Public Health Advisory. Washington, DC: FDA/Center for Drug Evaluation and Research, 2008. Available from: www.fda.gov/medwatch/report.htm [Updated 7 October 2008]
42. 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 • Data about tiotropium utilization in primary care.
43. Jara M, Lanes SF, Wentworth III C, et al. Comparative safety of long-acting inhaled bronchodilators. Drug Saf 2007;30:1151-1160 •• A very important and complete paper about tiotropium safety.
44. Gross NJ. Tiotropium Bromide. Chest 2004;126:1946-1953
45. 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 (Pubitemid 34162820)
46. Vincken W, van Noord JA, Greefhorst AP, et al. Dutch/Belgian Tiotropium Study Group. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002;19:209-216
47. Donohuse 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 (Pubitemid 34754142)
48. 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;58:399-404 • A clinical trial that compares two different class of long-acting bronchodilators. (Pubitemid 36560942)
49. Hasani A, Toms N, Agnew JE, et al. The effect of inhaled tiotropium bromide on lung mucociliary clearance in patients with COPD. Chest 2004;125:1726-1734 (Pubitemid 38648404)
50. 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;161:1136-1142 (Pubitemid 30243820)
51. 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 (Pubitemid 41266605)
52. Kario K, Uno H, Shimada K. Sleep-predominant lowering of ambulatory blood pressure by bedtime inhalation of a novel muscarinic M3 receptor antagonist: a new "Bronchoanthypertensive" strategy targeting the lung in hypertension with chronic obstructive pulmonary disease. Hypertens Res 2008;31:817-821
53. Rodrigo GJ, Nannini LJ. Tiotropium for the treatment of stable chronic obstructive pulmonary disease: a systematic review with meta-analysis. Pulm Pharmacol Ther 2007;20:495-502 • A well-performed systematic review with meta-analysis. (Pubitemid 47077638)
54. 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;128:1168-1178 •• A very interesting use of combination of two different therapeutic approaches in a complex disease as COPD.
55. 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 (Pubitemid 41324392)