As-needed ICS-LABA in Mild Asthma: What Does the Evidence Say?

Domingo, Christian; Rello, Jordi; Sogo, Ana

doi:10.1007/s40265-019-01202-0

Cited by 26 publications

(15 citation statements)

References 47 publications

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“…The results from the current analysis imply that under-treatment with ICS (as seen with ICS/formoterol as-needed approach in mild persistent) asthma could potentially result in chronic underlying inflammation and poorer clinical outcomes. In light of the results shown in clinical studies, it has been emphasised that more data on the long-term anti-inflammatory effects of ICS/formoterol as-needed in mild asthma are required [ 37 – 39 ], and the results from our study support these recommendations.…”

Section: Discussionsupporting

confidence: 69%

“…In mild asthma, treatment driven by clinical symptoms, including the ICS/formoterol as-needed approach, could allow underlying inflammation and BHR to persist and potentially worsen [34][35][36]. Indeed, evidence on the long-term effects of the ICS/ Formoterol as-needed approach, beyond 52 weeks, in controlling underlying inflammation, BHR and airway remodelling are lacking [37][38][39].…”

Section: Introductionmentioning

confidence: 99%

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Pharmacology Versus Convenience: A Benefit/Risk Analysis of Regular Maintenance Versus Infrequent or As-Needed Inhaled Corticosteroid Use in Mild Asthma

Daley‐Yates

Aggarwal²,

Lulic

et al. 2021

Adv Ther

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Introduction: This study compared the bronchoprotective and benefit/risk profiles of various inhaled corticosteroid (ICS) dosing regimens in mild asthma. Methods: A pharmacokinetic/pharmacodynamic model was developed and validated describing the relationship between ICS dose and time-course for airway bronchoprotection, [provocative concentration of adenosine monophosphate (AMP) causing C 20% decline in forced expiratory volume in 1 s (FEV 1 ) (AMP PC 20 )], for fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD). For regular ICS maintenance therapy (100% and 50% adherence) and infrequent or as-needed use (dosing 3-4 times per week), treatment effectiveness was expressed as percent time during 28 days when bronchoprotection exceeded either the threshold for a treatment-related bronchoprotective effect (AMP PC 20 C 0.25 doubling dose) or the threshold for a clinically significant bronchoprotective effect (AMP PC 20 C 1.0 doubling dose). This value was divided by the total ICS dose administered expressed in prednisolone equivalents to give a therapeutic index (TI). Results: The model-predicted time course of ICS-induced bronchoprotection with regular daily maintenance dosing and 100% adherence showed that all ICS at the highest recommended doses for mild asthma exceeded the threshold for clinically significant bronchoprotective effect for all or most of the 28-day dosing period, mean (90% CI); 100% (96.1-100), 99.9% (8.0-100) and 100% (58.2-100) with TI values of 16.9, 6.6 and 5.4 for FF 100 lg OD, FP 200 lg BID and BUD 200 lg BID, respectively. For simulated poor adherence (50%) to regular daily maintenance therapy, corresponding mean (90% CI) values were; 75.7% (39.4-89.1), 52.3% (0.7-69.2) and 51.3% (28.6-58.3) with TI values of 25.7, 6.9 and 5.6. For simulated infrequent/as needed use the corresponding values were;

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Section: Discussionsupporting

confidence: 69%

Section: Introductionmentioning

confidence: 99%

Pharmacology Versus Convenience: A Benefit/Risk Analysis of Regular Maintenance Versus Infrequent or As-Needed Inhaled Corticosteroid Use in Mild Asthma

Daley‐Yates

Aggarwal²,

Lulic

et al. 2021

Adv Ther

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“…Woodcock et al [41] defined eligible patients as those with a general practitioner diagnosis, which was based on medical records. This was likely to be more reliable than the self-reported doctor diagnosis adopted by Beasley et al [43] and Hardy et al [44], and may explain some of the criticisms of the latter two studies [62]. In the study of Beasley et al [43], as-needed budesonideformoterol reduced the number of exacerbations compared to SABA alone, but the study was conducted in a population in which SABA alone was not indicated (GINA step II) [4].…”

Section: Discussionmentioning

confidence: 99%

Asthma control factors in the Gulf Cooperation Council (GCC) countries and the effectiveness of ICS/LABA fixed dose combinations: a dual rapid literature review

Noibi¹,

Mohy²,

Gouhar³

et al. 2020

BMC Public Health

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Background: Asthma control is influenced by multiple factors. These factors must be considered when appraising asthma interventions and their effectiveness in the Gulf Cooperation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates [UAE]). Based on published studies, the most prevalent asthma treatment in these countries are fixed dose combinations (FDC) of inhaled corticosteroid and long-acting betaagonist (ICS/LABA). This study is a rapid review of the literature on: (a) factors associated with asthma control in the GCC countries and (b) generalisability of ICS/LABA FDC effectiveness studies. Methods: To review local factors associated with asthma control and, generalisability of published ICS/LABA FDC studies, two rapid reviews were conducted. Review 1 targeted literature pertaining to asthma control factors in GCC countries. Eligible studies were appraised, and clustering methodology used to summarise factors. Review 2 assessed ICS/LABA FDC studies in conditions close to actual clinical practice (i.e. effectiveness studies). Eligibility was determined by reviewing study characteristics. Evaluation of studies focused on randomised controlled trials (RCTs). In both reviews, initial (January 2018) and updated (November 2019) searches were conducted in EMBASE and PubMed databases. Eligible studies were appraised using the Critical Appraisal Skills Program (CASP) checklists. Results: We identified 51 publications reporting factors associated with asthma control. These publications reported studies conducted in Saudi Arabia (35), Qatar (5), Kuwait (5), UAE (3), Oman (1) and multiple countries (2). The most common factors associated with asthma control were: asthma-related education (13 articles), demographics (11articles), comorbidities (11 articles) and environmental exposures (11 articles). Review 2 identified 61 articles reporting ICS/LABA FDC effectiveness studies from countries outside of the GCC. Of these, six RCTs were critically appraised. The adequacy of RCTs in informing clinical practice varied when appraised against previously published criteria.

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“…Thus, some concerns are should be considered. For instance, Domingo et al contemplated their review whether reducing severe exacerbations or controlling symptoms was more important for asthma patients (Domingo et al, 2019). They arrived at no definite conclusion.…”

Section: Discussionmentioning

confidence: 99%

Is It Really Feasible to Use Budesonide–Formoterol as Needed for Mild Persistent Asthma? A Systematic Review and Meta-Analysis

Xiang

Liu

et al. 2021

Front. Pharmacol.

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Background: Previous studies suggest that inhaled budesonide-formoterol used as needed could effectively reduce the severe exacerbation of mild persistent asthma. However, there are some differences between these studies, so we conducted a meta-analysis.Methods: We searched PubMed, Ovid MEDLINE, Cochrane Library and several web search engines to screen the literature until March 25, 2020 and used risk ratios (RR), odds ratios, hazard ratios (HR) and weighted mean differences with 95% confidence intervals (CI) to evaluate the pooled effects. Adolescent/adult patients with mild persistent asthma who used budesonide–formoterol as needed were included in this study. The primary outcome was to investigate the superiority of budesonide–formoterol as needed in reducing severe exacerbations in patients with mild persistent asthma. STATA 12.0 software was used for statistical analysis.Results: Across all 4 articles, 4,023 patients used budesonide–formoterol as needed (budesonide–formoterol group), 4,042 patients used budesonide maintenance plus short-acting β2-agonist (SABA) as needed (budesonide group), and 1,500 patients used SABA as needed (SABA group). The results showed that the incidence of severe exacerbations and the time to first severe exacerbation in the budesonide–formoterol group were significantly different from those for the SABA group (RR = 0.46, 95% CI = 0.36–0.59, p < 0.001; HR = 0.43, 95% CI = 0.33–0.56, p < 0.001; respectively), but there was no difference between the budesonide–formoterol group and budesonide group (RR = 0.86, 95% CI = 0.62–1.04, p = 0.093; HR = 0.77, 95% CI = 0.57–1.03, p = 0.079; respectively). There were statistically significant differences in the forced expiratory volume in 1 second and in the responses to the Asthma Control Questionnaire-5 between the budesonide-formoterol group and the SABA group, but the differences were not clinically significant. In addition, the daily dose of budesonide in the budesonide–formoterol group was significantly lower than that in the budesonide group, and there was no difference in the incidence of adverse events among the three groups.Conclusion: In summary, budesonide–formoterol used as needed may reduce severe exacerbation in adolescent/adult patients with mild persistent asthma.

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As-needed ICS-LABA in Mild Asthma: What Does the Evidence Say?

Cited by 26 publications

References 47 publications

Pharmacology Versus Convenience: A Benefit/Risk Analysis of Regular Maintenance Versus Infrequent or As-Needed Inhaled Corticosteroid Use in Mild Asthma

Pharmacology Versus Convenience: A Benefit/Risk Analysis of Regular Maintenance Versus Infrequent or As-Needed Inhaled Corticosteroid Use in Mild Asthma

Asthma control factors in the Gulf Cooperation Council (GCC) countries and the effectiveness of ICS/LABA fixed dose combinations: a dual rapid literature review

Is It Really Feasible to Use Budesonide–Formoterol as Needed for Mild Persistent Asthma? A Systematic Review and Meta-Analysis

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