Safety of SABA Monotherapy in Asthma Management: a Systematic Review and Meta-analysis.
Adolescents
Adults
Adverse events
Monotherapy
Mortality
Overuse
SABA
Safety
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
received:
22
08
2022
accepted:
11
10
2022
pubmed:
9
11
2022
medline:
25
1
2023
entrez:
8
11
2022
Statut:
ppublish
Résumé
Short-acting β An SLR of English-language publications between January 1996 and December 2021 included RCTs and observational studies of patients aged ≥ 12 years treated with inhaled SABA reliever monotherapy (fixed dose or as needed) for ≥ 4 weeks. Studies of terbutaline and fenoterol were excluded. Meta-analysis feasibility was dependent on cross-trial data comparability. A random-effects model estimated rates of mortality, serious AEs (SAEs), and discontinuation due to AEs (DAEs) for as-needed and fixed-dose SABA treatment groups. ICS monotherapy and SABA therapy were compared using a fixed-effects model. Forty-two studies were identified by the SLR for assessment of feasibility. Final meta-analysis included 24 RCTs. Too few observational studies (n = 2) were available for inclusion in the meta-analysis. One death unrelated to treatment was reported in each of the ICS, ICS + LABA, and fixed-dose SABA groups. No other treatment-related deaths were reported. SAE and DAE rates were < 4%. DAEs were reported more frequently in the SABA treatment groups than with ICS, potentially owing to worsening asthma symptoms being classified as an AE. SAE risk was comparable between SABA and ICS treatments. Meta-analysis of data from RCTs showed that deaths were rare with SABA reliever monotherapy, and rates of SAEs and DAEs were comparable between SABA reliever and ICS treatment groups. When used appropriately within prescribed limits as reliever therapy, SABA does not contribute to excess rates of mortality, SAEs, or DAEs.
Identifiants
pubmed: 36348141
doi: 10.1007/s12325-022-02356-2
pii: 10.1007/s12325-022-02356-2
pmc: PMC9859883
doi:
Substances chimiques
Ethanolamines
0
Terbutaline
N8ONU3L3PG
Adrenal Cortex Hormones
0
Anti-Asthmatic Agents
0
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Review
Langues
eng
Pagination
133-158Subventions
Organisme : GSK
ID : Study ID 218222
Informations de copyright
© 2022. The Author(s).
Références
National Heart LaBI. Guidelines for the diagnosis and management of asthma (EPR-3); 2007. https://www.nhlbi.nih.gov/sites/default/files/media/docs/EPR-3_Asthma_Full_Report_2007.pdf . Accessed May 2022.
Crompton G. A brief history of inhaled asthma therapy over the last fifty years. Prim Care Respir J. 2006;15:326–31.
doi: 10.1016/j.pcrj.2006.09.002
Hills T, Beasley R. The history and future of short-acting β2-agonist therapy in asthma. Respirology. 2020;25:246–8.
doi: 10.1111/resp.13727
Sanders M. Inhalation therapy: an historical review. Prim Care Respir J. 2007;16:71–81.
doi: 10.3132/pcrj.2007.00017
Global Initiative for Asthma (GINA). Global Strategy for asthma management and prevention; 2018. https://ginasthma.org/wp-content/uploads/2019/01/2018-GINA.pdf . Accessed June 2022.
Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention; 2022. https://ginasthma.org/wp-content/uploads/2022/05/GINA-Main-Report-2022-FINAL-22-05-03-WMS.pdf . Accessed May 2022.
Gibbons DC, Aggarwal B, Fairburn-Beech J, et al. Treatment patterns among non-active users of maintenance asthma medication in the United Kingdom: a retrospective cohort study in the Clinical Practice Research Datalink. J Asthma. 2021;58:793–804.
doi: 10.1080/02770903.2020.1728767
Nwaru BI, Ekstrom M, Hasvold P, Wiklund F, Telg G, Janson C. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020. https://doi.org/10.1183/13993003.01872-2019 .
doi: 10.1183/13993003.01872-2019
Sears MR, Taylor DR. The beta 2-agonist controversy. Observations, explanations and relationship to asthma epidemiology. Drug Saf. 1994;11:259–83.
doi: 10.2165/00002018-199411040-00005
Beasley R, Pearce N, Crane J, Burgess C. Beta-agonists: what is the evidence that their use increases the risk of asthma morbidity and mortality? J Allergy Clin Immunol. 1999;104:S18-30.
doi: 10.1016/S0091-6749(99)70270-8
Crane J, Pearce N, Burgess C, Beasley R. Fenoterol and asthma death. N Z Med J. 1989;102:356–7.
Pearce N, Crane J, Burgess C, Grainger J, Beasley R. Fenoterol and asthma mortality in New Zealand. N Z Med J. 1990;103:73–5.
Grainger J, Woodman K, Pearce N, et al. Prescribed fenoterol and death from asthma in New Zealand, 1981–7: a further case–control study. Thorax. 1991;46:105–11.
doi: 10.1136/thx.46.2.105
Spitzer WO, Ernst P, Suissa S, et al. Fenoterol and death from asthma. Med J Aust. 1992;157:567–8.
doi: 10.5694/j.1326-5377.1992.tb137366.x
Suissa S, Ernst P, Boivin JF, et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am J Respir Crit Care Med. 1994;149:604–10.
doi: 10.1164/ajrccm.149.3.8118625
Suissa S, Ernst P, Benayoun S, Baltzan M, Cai B. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med. 2000;343:332–6.
doi: 10.1056/NEJM200008033430504
Busse W, Stempel D, Aggarwal B, et al. Insights from the AUSTRI study on reliever use before and after asthma exacerbations. J Allergy Clin Immunol Pract. 2022;10:1916-182.E2.
doi: 10.1016/j.jaip.2022.03.029
Ye Q, He X-O, D’Urzo A. A review on the safety and efficacy of inhaled corticosteroids in the management of asthma. Pulm Ther. 2017;3:1–18.
doi: 10.1007/s41030-017-0043-5
Beasley R, Pearce N, Crane J, Windom H, Burgess C. Asthma mortality and inhaled beta agonist therapy. Aust N Z J Med. 1991;21:753–63.
doi: 10.1111/j.1445-5994.1991.tb01385.x
National Institute for Health Care Excellence. Guide to the Methods of Technology Appraisal 2013. London: National Institute for Health and Care Excellence (NICE) Copyright © 2013 National Institute for Health and Clinical Excellence, unless otherwise stated. All rights reserved; 2013.
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60.
doi: 10.1136/bmj.327.7414.557
Abramson MJ, Bailey MJ, Couper FJ, et al. Are asthma medications and management related to deaths from asthma? Am J Respir Crit Care Med. 2001;163:12–8.
doi: 10.1164/ajrccm.163.1.9910042
Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, Group SS. The salmeterol multicenter asthma research trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129:15–26.
doi: 10.1378/chest.129.1.15
O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide–formoterol as needed in mild asthma. N Engl J Med. 2018;378:1865–76.
doi: 10.1056/NEJMoa1715274
Pleskow W, LaForce CF, Yegen U, Matos D, Della CG. Formoterol delivered via the dry powder Aerolizer inhaler versus albuterol MDI and placebo in mild-to-moderate asthma: a randomized, double-blind, double-dummy trial. J Asthma. 2003;40:505–14.
doi: 10.1081/JAS-120018780
Beasley R, Holliday M, Reddel HK, et al. Controlled trial of budesonide–formoterol as needed for mild asthma. N Engl J Med. 2019;380:2020–30.
doi: 10.1056/NEJMoa1901963
FitzGerald JM, Chapman KR, Della Cioppa G, et al. Sustained bronchoprotection, bronchodilatation, and symptom control during regular formoterol use in asthma of moderate or greater severity. The Canadian FO/OD1 Study Group. J Allergy Clin Immunol. 1999;103:427–35.
doi: 10.1016/S0091-6749(99)70467-7
Hamilos DL, D’Urzo A, Levy RJ, et al. Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. Ann Allergy Asthma Immunol. 2007;99:540–8.
doi: 10.1016/S1081-1206(10)60384-5
Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc. 2009;30:293–303.
doi: 10.2500/aap.2009.30.3241
Kearns N, Williams M, Bruce P, et al. Single dose of budesonide/formoterol turbuhaler compared to salbutamol pMDI for speed of bronchodilator onset in asthma: a randomised cross-over trial. Thorax. 2022. https://doi.org/10.1136/thorax-2022-219052 .
doi: 10.1136/thorax-2022-219052
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. 1993;306:1034–7.
doi: 10.1136/bmj.306.6884.1034
Bensch G, Lapidus RJ, Levine BE, et al. A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler. Ann Allergy Asthma Immunol. 2001;86:19–27.
doi: 10.1016/S1081-1206(10)62351-4
Berger WE, Ford LB, Mahr T, et al. Efficacy and safety of fluticasone propionate 250 microg administered once daily in patients with persistent asthma treated with or without inhaled corticosteroids. Ann Allergy Asthma Immunol. 2002;89:393–9.
doi: 10.1016/S1081-1206(10)62041-8
Condemi JJ, Chervinsky P, Goldstein MF, et al. Fluticasone propionate powder administered through Diskhaler versus triamcinolone acetonide aerosol administered through metered-dose inhaler in patients with persistent asthma. J Allergy Clin Immunol. 1997;100:467–74.
doi: 10.1016/S0091-6749(97)70137-4
Drazen JM, Israel E, Boushey HA, et al. Comparison of regularly scheduled with as-needed use of albuterol in mild asthma. Asthma Clinical Research Network. N Engl J Med. 1996;335:841–7.
doi: 10.1056/NEJM199609193351202
Galant SP, Lawrence M, Meltzer EO, Tomasko M, Baker KA, Kellerman DJ. Fluticasone propionate compared with theophylline for mild-to-moderate asthma. Ann Allergy Asthma Immunol. 1996;77:112–8.
doi: 10.1016/S1081-1206(10)63496-5
Galant SP, van Bavel J, Finn A, et al. Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma. Ann Allergy Asthma Immunol. 1999;82:273–80.
doi: 10.1016/S1081-1206(10)62608-7
Jacobson K, Chervinsky P, Noonan M, Kane RE, Banerji D, Uryniak T. Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group. Ann Allergy Asthma Immunol. 1999;83:327–33.
doi: 10.1016/S1081-1206(10)62673-7
Kavuru M, Melamed J, Gross G, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2000;105:1108–16.
doi: 10.1067/mai.2000.105711
Kemp J, Wolfe J, Grady J, et al. Salmeterol powder compared with albuterol aerosol as maintenance therapy for asthma in adolescent and adult patients. Clin Ther. 1998;20:270–82.
doi: 10.1016/S0149-2918(98)80090-8
Malmstrom K, Rodriguez-Gomez G, Guerra J, et al. Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma. A randomized, controlled trial. Montelukast/beclomethasone study group. Ann Intern Med. 1999;130:487–95.
doi: 10.7326/0003-4819-130-6-199903160-00005
Nathan RA, Pinnas JL, Schwartz HJ, et al. A six-month, placebo-controlled comparison of the safety and efficacy of salmeterol or beclomethasone for persistent asthma. Ann Allergy Asthma Immunol. 1999;82:521–9.
doi: 10.1016/S1081-1206(10)63159-6
Nathan RA, Rooklin A, Schoaf L, et al. Efficacy and tolerability of fluticasone propionate/salmeterol administered twice daily via hydrofluoroalkane 134a metered-dose inhaler in adolescent and adult patients with persistent asthma: a randomized, double-blind, placebo-controlled, 12-week study. Clin Ther. 2006;28:73–85.
doi: 10.1016/j.clinthera.2006.01.008
Nelson H, Kemp JP, Bieler S, Vaughan LM, Hill MR. Comparative efficacy and safety of albuterol sulfate spiros inhaler and albuterol metered-dose inhaler in asthma. Chest. 1999;115:329–35.
doi: 10.1378/chest.115.2.329
Salat D, Popov D, Sykes AP. Equivalence of salbutamol 200 microg four times daily propelled by propellants 11 and 12 or HFA 134a in mild to moderate asthmatics. Eastern European study group. Respir Med. 2000;94 Suppl B:S22-8.
Sheffer AL, LaForce C, Chervinsky P, Pearlman D, Schaberg A. Fluticasone propionate aerosol: efficacy in patients with mild to moderate asthma. Fluticasone Propionate Asthma Study Group. J Fam Pract. 1996;42:369–75.
Tammivaara R, Aalto E, Lehtonen K, et al. Comparison of a novel salbutamol multidose powder inhaler with a salbutamol metered dose inhaler in patients with asthma. CTR. 1997;58:734–44.
Taylor DR, Town GI, Herbison GP, et al. Asthma control during long-term treatment with regular inhaled salbutamol and salmeterol. Thorax. 1998;53:744–52.
doi: 10.1136/thx.53.9.744
Tinkelman DG, Bleecker ER, Ramsdell J, et al. Proventil HFA and ventolin have similar safety profiles during regular use. Chest. 1998;113:290–6.
doi: 10.1378/chest.113.2.290
ZuWallack R, Adelglass J, Clifford DP, et al. Long-term efficacy and safety of fluticasone propionate powder administered once or twice daily via inhaler to patients with moderate asthma. Chest. 2000;118:303–12.
doi: 10.1378/chest.118.2.303