Stopping long-acting beta<sub>2</sub>-agonists (LABA) for adults with asthma well controlled by LABA and inhaled corticosteroids

Ahmad, Shaleen; Kew, Kayleigh M; Normansell, Rebecca

doi:10.1002/14651858.cd011306.pub2

Cited by 18 publications

(7 citation statements)

References 39 publications

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“…We do not know whether patients discontinued LABA because they had achieved good control over their asthma symptoms or for other reasons. For confirmation of appropriate step-down therapy, more granular clinical data (e.g., symptoms and pulmonary function and safety outcomes) and careful evaluation of long-term stability are needed; 18 – 21 however, these data were not available in this current US claims database.…”

Section: Discussionmentioning

confidence: 99%

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

Zhou¹,

Seymour²,

Goulding³

et al. 2017

JAA

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BackgroundEmerging safety issues associated with long-acting beta2-agonist (LABA) have led to multiple regulatory activities by the US Food and Drug Administration (FDA) since 2003, including Drug Safety Communications (DSCs) in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment.MethodsWe examined the initiation of LABA-containing products for adult asthma treatment using an intermittent time series approach in a claims database from 2003 to 2012. We assessed the alignment of dispensing patterns with the following 2010 FDA recommendations: 1) contraindicated use of single-ingredient (SI)-LABA without an asthma controller medication (ACM); 2) a LABA should only be used when asthma is not adequately controlled on inhaled corticosteroids (ICSs) or ACM; and 3) step-down asthma therapy (e.g., discontinue LABA) when asthma control is achieved.ResultsThere were 477,922 adults (18–64 years old) dispensed a new LABA during 2003–2012. Among LABA initiators, patients who initiated an SI-LABA and who did “not” have an ACM dispensed on the same date decreased from >9% in 2003 (the initial labeling change) to <2% post 2010 DSCs (p-value <0.0001 in the segmented regression model). The proportion of asthma patients dispensed an ICS in 6 months prior to initiating LABA treatment did not increase. The proportion of patients with longer than 4 months of continuous treatment did not decrease over the study period.ConclusionAlthough the decrease in SI-LABA initiation is consistent with FDA’s recommendations, low ICS dispensing before initiating a LABA and LABA continuation practices require further efforts to move toward the recommended safe practices.

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Section: Discussionmentioning

confidence: 99%

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

Zhou¹,

Seymour²,

Goulding³

et al. 2017

JAA

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“…Two Cochrane reviews found insufficient trial evidence regarding step down of ICS or long-acting beta agonists (LABA). 16 , 17 Participants in our study used a variety of approaches to step down, reducing both ICS and LABA or just ICS; with even less concord for patients with an additional asthma therapy. Moreover, there was no consensus as to how to identify suitable patients.…”

Section: Discussionmentioning

confidence: 99%

<p>Qualitative Study of Practices and Challenges of Stepping Down Asthma Medication in Primary Care Across the UK</p>

Bloom¹,

Ramsey²,

Alter³

et al. 2020

JAA

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Background: Guidelines recommend that asthma treatment should be stepped down to the minimally effective dose that achieves symptom control to prevent medication side effects and reduce unnecessary costs. Little is known about the practice of stepping down and the challenges in primary care, where most asthma patients are managed. Objective: To explore views, experiences, barriers and ideas, of doctors, nurses and pharmacists working in primary care, related to step down of asthma medication. Methods: Primary care practitioners from across the UK participated in a survey and/or semi-structured interview. Questions explored four main areas: how asthma medication is reviewed, views on asthma guidelines, perceived barriers faced by healthcare workers and facilitators of stepping down. Qualitative content analysis enabled data coding of interview transcripts to identify major themes. Results: A total of 274 participants responded to the survey, 29 participated in an interview (12 doctors, 9 nurses, and 8 pharmacists), working in GP practices from across the UK. Nearly half of the survey participants infrequently step down asthma medication (doc-tors=42.7%, nurses=46.3%). Four major themes related to barriers to stepping down were (i) lack of awareness of the need to step down, (ii) inertia to step down, driven by low confidence in ability, fear of consequences, and concern for who is responsible for stepping down, (iii) self-efficacy of ability to step down, influenced by lack of clear, applied guidance and limited training, and (iv) feasibility of step down, driven by a lack of systematic acceptance of stepping down and time. Strategies proposed to reduce overtreatment included education and training, improved gathering of evidence and guidance, and integrating step down into routine asthma care. Conclusion: Failure to implement this guideline recommendation into everyday asthma management is influenced by several contributing factors. Future directions should include addressing evidence gaps, implementing clear and practical guidance, integration of stepdown assessment into the asthma review, and education of professionals and patients.

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“…Another possibility for adjusting the controller medication would be to eliminate the LABA from the combination, returning to the use of ICS therapy alone. However, a meta-analysis of studies involving adults (59) showed that the elimination of the LABA leads to a reduction in the quality of life and in asthma control. A subanalysis of a recent RCT (45) comparing the ICS+LABA combination with ICS alone showed that, in patients with asthma that was well controlled with ICS+LABA, the shift to ICS alone significantly increased the risk of exacerbations.…”

Section: Control-based Asthma Management In Stepsmentioning

confidence: 99%

2020 Brazilian Thoracic Association recommendations for the management of asthma

et al. 2020

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The pharmacological management of asthma has changed considerably in recent decades, as it has come to be understood that it is a complex, heterogeneous disease with different phenotypes and endotypes. It is now clear that the goal of asthma treatment should be to achieve and maintain control of the disease, as well as to minimize the risks (of exacerbations, disease instability, accelerated loss of lung function, and adverse treatment effects). That requires an approach that is personalized in terms of the pharmacological treatment, patient education, written action plan, training in correct inhaler use, and review of the inhaler technique at each office visit. A panel of 22 pulmonologists was invited to perform a critical review of recent evidence of pharmacological treatment of asthma and to prepare this set of recommendations, a treatment guide tailored to use in Brazil. The topics or questions related to the most significant changes in concepts, and consequently in the management of asthma in clinical practice, were chosen by a panel of experts. To formulate these recommendations, we asked each expert to perform a critical review of a topic or to respond to a question, on the basis of evidence in the literature. In a second phase, three experts discussed and structured all texts submitted by the others. That was followed by a third phase, in which all of the experts reviewed and discussed each recommendation. These recommendations, which are intended for physicians involved in the treatment of asthma, apply to asthma patients of all ages.

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Stopping long-acting beta₂-agonists (LABA) for adults with asthma well controlled by LABA and inhaled corticosteroids

Cited by 18 publications

References 39 publications

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

<p>Qualitative Study of Practices and Challenges of Stepping Down Asthma Medication in Primary Care Across the UK</p>

2020 Brazilian Thoracic Association recommendations for the management of asthma

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Stopping long-acting beta2-agonists (LABA) for adults with asthma well controlled by LABA and inhaled corticosteroids

Cited by 18 publications

References 39 publications

The US Food and Drug Administration&rsquo;s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003&ndash;2012

The US Food and Drug Administration&rsquo;s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003&ndash;2012

<p>Qualitative Study of Practices and Challenges of Stepping Down Asthma Medication in Primary Care Across the UK</p>

2020 Brazilian Thoracic Association recommendations for the management of asthma

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Product

Resources

About

Stopping long-acting beta₂-agonists (LABA) for adults with asthma well controlled by LABA and inhaled corticosteroids

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012