Safety of formoterol in asthma clinical trials: An update

European Respiratory Journal

Volumn 43, Issue 1, 2014, Pages 103-114

  Sears, Malcolm R ^a   Radner, Finn ^b  

^a MCMASTER UNIVERSITY   (Canada)

^b ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; BUDESONIDE PLUS FORMOTEROL; FORMOTEROL; SALMETEROL;

ASTHMA; DRUG SAFETY; DRUG WITHDRAWAL; HEART DISEASE; HUMAN; MORTALITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; ASTHMA; ETHANOLAMINES; HUMANS;

EID: 84891943693     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/09031936.00004713     Document Type: Review

References (37)

1. Murphy S, Roberts R. ''Black-box'' 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol 2006; 117: 34-39.
2. Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: Comparison of salmeterol with salbutamol in asthmatic patient.who.require regular bronchodilator treatment. BMJ 1993; 306: 1034-1037.
3. Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: A comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006; 129: 15-26.
4. McIvor RA, Pizzichini E, Turner MO, et al. Potential masking effects of salmeterol on airway inflammation in asthma. Am J Respir Crit Care Med 1998; 158: 924-930.
5. M. Levenson. Long-acting Beta-agonists and Adverse Asthma Events Meta-analysis. Statistical briefing package for joint meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Paediatric Advisory Committee, 2008. www.fda.gov/ohrms/ dockets/ac/cder08.html# PulmonaryAllergy Date last updated: November 12, 2008. Date last accessed: November 6, 2013.
6. Bateman E, Nelson H, Bousquet J, et al. Meta-analysis: Effects of adding salmeterol to inhaled corticosteroids on serious asthma-related events. Ann Intern Med 2008; 149: 33-42.
7. Jaeschke R, O'Byrne PM, Mezja F, et al. The safety of long-acting b-agonists among patients with asthma using inhaled corticosteroids. Systematic review and meta-analysis. Am J Respir Crit Care Med 2008; 178: 1009-1016.
8. Sears MR, Ottosson A, Radner F, et al. Long-acting beta-agonists: A review of formoterol safety data from asthma clinical trials. Eur Respir J 2009; 33: 21-32.
9. Rodrigo GJ, Moral VP, Marcos LG, et al. Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. Pulm Pharmacol Ther 2009; 22: 9-19.
10. Cates CJ, Lasserson TJ, Jaeschke R. Regular treatment with salmeterol and inhaled steroids for chronic asthma: Serious adverse events. Cochrane Database Syst Rev 2009; 3: CD006922.
11. Sears MR, Radner F. Safety of budesonide/formoterol maintenance and reliever therapy in asthma trials. Respir Med 2009; 103: 1960-1968.
12. Nelson H, Bonuccelli C, Radner F, et al. Safety of formoterol in patients with asthma: Combined analysis of data from double-blind, randomized controlled trials. J Allergy Clin Immunol 2010; 125: 390-396.
13. Price JF, Radner F, Lenney W, et al. Safety of formoterol in children and adolescents: Experience from asthma clinical trials. Arch Dis Child 2010; 95: 1047-1053.
14. Nelson HS, Carr W, Nathan R, et al. Update on the safety of long-acting beta-agonists in combination with inhaled corticosteroid for the treatment of asthma. Ann Asthma Allergy Immunol 2009; 102: 11-15.
15. Rodrigo GJ, Castro-Rodŕguez JA. Safety of long-acting b agonists for the treatment of asthma: Clearing the air. Thorax 2012; 67: 342-349.
16. Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; 362: 1169-1171.
17. Lemanske RF, Busse WW. The US Food and Drug Administration and long-acting b2-agonists: The importance of striking the right balance between risks and benefits of therapy J Allergy Clin Immunol 2010; 126: 449-452.
18. Reddel HK, Gibson PG, Peters MJ, et al. Down-titration from high-dose combination therapy in asthma: Removal of long-acting b2-agonist. Respir Med 2010; 104: 1110-1120.
19. Hagiwara M, Delea TE, Stanford RH, et al. Stepping down to fluticasone propionate or a lower dose of fluticasone propionate/salmeterol combination in asthma patients recently initiating combination therapy. Allergy Asthma Proc 2010; 31: 203-210.
20. Brozek JL, Kraft M, Krishnan JA, et al. Long-acting b2-agonist step-off in patients with controlled asthma. Arch Intern Med 2012; 172: 1365-1375.
21. Chowdhury BA, Seymour SM, Levenson MS. Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma. N Engl J Med 2011; 364: 2473-2475.
22. Sears MR. Safety of long-acting beta-agonists: Are new data really required Chest 2009; 136: 604-607.
23. Szefler SJ, Busse WW, for the Paediatric and Joint Adult Steering Committees. Adding LABAs to inhaled glucocorticoids for asthma. N Engl J Med 2011; 365: 1260-1261.
24. Sears MR. The FDA-mandated trial of safety of long-acting beta-agonists in asthma: Finality or futilityThorax 2013; 68: 195-198.
25. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007; 61: 725-736.
26. Von Berg A, Papageorgiou Saxoni F, Wille S, et al. Efficacy and tolerability of formoterol Turbuhaler in children. Int J Clin Pract 2003; 57: 852-856.
27. StatXact. www.cytel.com/software/statxact Date last accessed: November 7, 2013.
28. McMahon AW, Levenson MS, McEvoy BW, et al. Age and risks of FDA-approved long-acting b2-adrenergic receptor agonists. Pediatrics 2011; 128: E1147-e1154.
29. Spector SL, Martin UJ, Uryniak T, et al. Budesonide/formoterol pressurized metered-dose inhaler versus budesonide: A randomized controlled trial in black patients with asthma. J Asthma 2012; 49: 70-77.
30. Brown RW, O'Brien CD, Martin UJ, et al. Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial. J Allergy Clin Immunol 2012; 130: 362-367.
31. Wells KE, Peterson EL, Ahmedani BK, et al. The relationship between combination inhaled corticosteroid and longacting b-agonist use and severe asthma exacerbations in a diverse population. J Allergy Clin Immunol 2012; 179: 1274-1279.
32. Sears MR. Safe use of long-acting b-agonists: what have we learnt Expert Opin Drug Saf 2011; 10: 767-778.
33. Cates CJ, Oleszczuk M, Stovold E, et al. Safety of regular formoterol or salmeterol in children with asthma: An overview of Cochrane reviews. Cochrane Database Syst Rev 2012; 10: CD010005.
34. Ni Chroinin M, Greenstone I, Lasserson TJ, et al. Addition of long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children. Cochrane Database Syst Rev 2009; 4: CD005307.
35. Ni Chroinin M, Lasserson TJ, Greenstone I, et al. Addition of long-acting beta-agonists to inhaled corticosteroids for chronic asthma in children. Cochrane Database Syst Rev 2009; 3: CD007949.
36. Ducharme FM, Ni Chroinin M, Greenstone I, et al. Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma. Cochrane Database Syst Rev 2010; 4: CD005533.
37. Ducharme FM, Ni Chroinin M, Greenstone I, et al. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database Sys Rev 2010; 5: CD005535.