Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate

Journal of Allergy and Clinical Immunology

Volumn 143, Issue 4, 2019, Pages 1395-1402

  Weinstein, Cindy L J ^a   Ryan, Nicholas ^b   Shekar, Tulin ^c   Gates, Davis ^c   Lane, Stephen J ^d   Agache, Ioana ^e   Nathan, Robert A ^f  

^a Respiratory and Immunology Clinical Development   (United States)

^b Clinical Sciences   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

^d ADELAIDE AND MEATH HOSPITAL   (Ireland)

^e TRANSILVANIA UNIVERSITY OF BRASOV   (Romania)

^f Asthma and Allergy Associates and Research Center   (United States)

Author keywords

asthma exacerbations; Formoterol; long acting agonists; mometasone furoate; persistent asthma; serious asthma events

Indexed keywords

FORMOTEROL; MOMETASONE FUROATE; BRONCHODILATING AGENT; FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE;

ADOLESCENT; ADULT; AGED; ARTICLE; ASTHMA; CHILD; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHENOTYPE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; MIDDLE AGED; RECURRENT DISEASE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ASTHMA; BRONCHODILATOR AGENTS; CHILD; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MOMETASONE FUROATE; MOMETASONE FUROATE, FORMOTEROL FUMARATE DRUG COMBINATION; SYMPTOM FLARE UP; YOUNG ADULT;

EID: 85060087843     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2018.10.065     Document Type: Article

References (15)

1. Nelson, H.S., Carr, W., Nathan, R., Portnoy, J.M., Update on the safety of long-acting beta-agonists in combination with inhaled corticosteroids for the treatment of asthma. Ann Allergy Asthma Immunol 102 (2009), 11–15.
2. Castle, W., Fuller, R., Hall, J., Palmer, J., Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ 306 (1993), 1034–1037.
3. Nelson, H.S., Weiss, S.T., Bleecker, E.R., Yancey, S.W., Dorinsky, P.M., The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 129 (2006), 15–26.
4. Sears, M.R., Ottosson, A., Radner, F., Suissa, S., Long-acting beta-agonists: a review of formoterol safety data from asthma clinical trials. Eur Respir J 33 (2009), 21–32.
5. Sears, M.R., Radner, F., Safety of formoterol in asthma clinical trials: an update. Eur Respir J 43 (2014), 103–114.
6. Nelson, H., Bonuccelli, C., Radner, F., Ottosson, A., Carroll, K.J., Andersson, T.L., et al. Safety of formoterol in patients with asthma: combined analysis of data from double-blind, randomized controlled trials. J Allergy Clin Immunol 125 (2010), 390–396.e8.
7. Statistical Briefing Package for Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Pediatric Advisory Committee on December 10-11, 2008. Available at: https://wayback.archive-it.org/7993/20170405035612/https://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-01-FDA.pdf. (Accessed 7 June 2018)
8. Chowdhury, B.A., Dal Pan, G., The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 362 (2010), 1169–1171.
9. FDA drug safety communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs) 15 April 2011. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm251512.htm. (Accessed 1 December 2017)
10. Stempel, D.A., Raphiou, I.H., Kral, K.M., Yeakey, A.M., Emmett, A.H., Prazma, C.M., et al. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med 374 (2016), 1822–1830.
11. Stempel, D.A., Szefler, S.J., Pedersen, S., Zeiger, R.S., Yeakey, A.M., Lee, L.A., et al. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med 375 (2016), 840–849.
12. Peters, S.P., Bleecker, E.R., Canonica, G.W., Park, Y.B., Ramirez, R., Hollis, S., et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med 375 (2016), 850–860.
13. FDA drug safety communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). Available at: https://www.fda.gov/Drugs/DrugSafety/ucm589587.htm?utm_campaign=New%20FDA%20Drug%20Safety%20Communication%20update%20on%20long-acting%20beta%20agonists%20(LABAs)&utm_medium=email&utm_source=Eloqua. (Accessed 15 March 2018)
14. Wells, K., Pladevall, M., Peterson, E.L., Campbell, J., Wang, M., Lanfear, D.E., et al. Race-ethnic differences in factors associated with inhaled steroid adherence among adults with asthma. Am J Respir Crit Care Med 178 (2008), 1194–1201.
15. Williams, L.K., Pladevall, M., Xi, H., Peterson, E.L., Joseph, C., Lafata, J.E., et al. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol 114 (2004), 1288–1293.