Prevalence of overuse of short-acting beta-2 agonists (SABA) and associated factors among patients with asthma in Germany

Abstract Background Overuse of short-acting beta-2 agonists (SABA), which do not treat the underlying inflammation of asthma, is linked to poor clinical outcomes such as increased exacerbation risk. This study, as part of the SABINA program, estimated the prevalence of SABA overuse and associated variables in outpatients in Germany. Methods This retrospective study used anonymized electronic healthcare data from the Disease Analyzer database (IQVIA). A total of 15,640 patients aged ≥ 12 years with asthma who received ≥ 1 SABA prescription(s) between July 2017 and June 2018 in 924 general physician and 22 pneumologist (PN) practices were included. SABA overuse was defined as ≥ 3 prescribed inhalers (~ 200 puffs each) during the study period. The associations between SABA overuse and physician specialty, Global Initiative for Asthma (GINA) steps (based on asthma medications), age, sex, and inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) use were estimated using multivariable regression for patients with probable moderate (GINA step 2) and probable severe (GINA steps 3–5) asthma. Results Annually, 36% of all patients (GINA steps 1–5) in general and 38% in PN practices received ≥ 3 SABA inhalers. The risk of SABA overuse was 14% higher in patients treated by a general practitioner vs. a PN; 34% and 85% higher in GINA steps 4 and 5, respectively, vs. GINA step 3; and 40% higher in male vs. female patients. Conclusions SABA overuse is prevalent among patients with asthma across all GINA steps in Germany, which may indicate suboptimal asthma control. Further studies are needed to investigate the reasons behind SABA overuse.

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Effective Asthma Management: Is It Time to Let the AIR out of SABA?

Journal of Clinical Medicine ◽

10.3390/jcm9040921 ◽

2020 ◽

Vol 9 (4) ◽

pp. 921

Author(s):

Alan Kaplan ◽

Patrick D. Mitchell ◽

Andrew J. Cave ◽

Remi Gagnon ◽

Vanessa Foran ◽

...

Keyword(s):

Asthma Management ◽

Beta Agonist ◽

Inhaled Corticosteroid ◽

Short Acting ◽

Asthma Symptoms ◽

Beta Agonists ◽

Global Initiative For Asthma ◽

Global Initiative ◽

Poor Outcomes ◽

Fast Acting

For years, standard asthma treatment has included short acting beta agonists (SABA), including as monotherapy in patients with mild asthma symptoms. In the Global Initiative for Asthma 2019 strategy for the management of asthma, the authors recommended a significant departure from the traditional treatments. Short acting beta agonists (SABAs) are no longer recommended as the preferred reliever for patients when they are symptomatic and should not be used at all as monotherapy because of significant safety concerns and poor outcomes. Instead, the more appropriate course is the use of a combined inhaled corticosteroid–fast acting beta agonist as a reliever. This paper discusses the issues associated with the use of SABA, the reasons that patients over-use SABA, difficulties that can be expected in overcoming SABA over-reliance in patients, and our evolving understanding of the use of “anti-inflammatory relievers” in our patients with asthma.

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First analysis of the Severe Paediatric Asthma Collaborative in Europe registry

ERJ Open Research ◽

10.1183/23120541.00566-2020 ◽

2020 ◽

Vol 6 (4) ◽

pp. 00566-2020

Author(s):

Norrice M. Liu ◽

Karin C.L. Carlsen ◽

Steve Cunningham ◽

Grazia Fenu ◽

Louise J. Fleming ◽

...

Keyword(s):

Asthma Control ◽

Severe Asthma ◽

Suboptimal Control ◽

High Dose ◽

Asthma Control Test ◽

European Respiratory Society ◽

Paediatric Asthma ◽

Global Initiative For Asthma ◽

Global Initiative ◽

Long Acting

New biologics are being continually developed for paediatric asthma, but it is unclear whether there are sufficient numbers of children in Europe with severe asthma and poor control to recruit to trials needed for registration. To address these questions, the European Respiratory Society funded the Severe Paediatric Asthma Collaborative in Europe (SPACE), a severe asthma registry. We report the first analysis of the SPACE registry, which includes data from 10 paediatric respiratory centres across Europe.Data from 80 children with a clinical diagnosis of severe asthma who were receiving both high-dose inhaled corticosteroid and long-acting β2-agonist were entered into the registry between January 2019 and January 2020. Suboptimal control was defined by either asthma control test, or Global Initiative for Asthma criteria, or ≥2 severe exacerbations in the previous 12 months, or a combination.Overall, 62 out of 80 (77%) children had suboptimal asthma control, of whom 29 were not prescribed a biologic. However, in 24 there was an option for starting a licensed biologic. 33 children with suboptimal control were prescribed a biologic (omalizumab (n=24), or mepolizumab (n=7), or dupilumab (n=2)), and for 29 there was an option to switch to a different biologic.We conclude that the SPACE registry provides data that will support the planning of studies of asthma biologics. Not all children on biologics achieve good asthma control, and there is need for new trial designs addressing biologic switching.

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Global Initiative for Asthma (GINA) Strategy 2021 - Executive summary and rationale for key changes

European Respiratory Journal ◽

10.1183/13993003.02730-2021 ◽

2021 ◽

pp. 2102730

Author(s):

Helen K. Reddel ◽

Leonard B. Bacharier ◽

Eric D. Bateman ◽

Christopher E. Brightling ◽

Guy G. Brusselle ◽

...

Keyword(s):

Severe Asthma ◽

Inhaled Corticosteroids ◽

Age Groups ◽

Skills Training ◽

Mild Asthma ◽

Executive Summary ◽

Global Initiative For Asthma ◽

Global Initiative ◽

Long Acting ◽

Beta2 Agonist

The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes.GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting beta2-agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as- needed combination ICS-formoterol reduces severe exacerbations by >60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function and inflammatory outcomes as daily ICS plus as-needed SABA.Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 (preferred) has low-dose ICS-formoterol as the reliever at all steps: as-needed only in Steps 1-2 (mild asthma), and with daily maintenance ICS-formoterol (maintenance-and-reliever therapy, MART) in Steps 3-5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS-long-acting beta2-agonist (LABA) (Steps 3-5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6-11 years, new treatment options are added at Steps 3-4.Across all age-groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment and review remain essential to optimize asthma outcomes.

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Comparing LAMA with LABA and LTRA as add-on therapies in primary care asthma management

npj Primary Care Respiratory Medicine ◽

10.1038/s41533-020-00205-9 ◽

2020 ◽

Vol 30 (1) ◽

Author(s):

Alan Kaplan ◽

J. Mark FitzGerald ◽

Roland Buhl ◽

Christian Vogelberg ◽

Eckard Hamelmann

Keyword(s):

Primary Care ◽

Lung Function ◽

Inhaled Corticosteroids ◽

Asthma Management ◽

Global Initiative For Asthma ◽

Control Asthma ◽

Global Initiative ◽

Long Acting ◽

Randomised Controlled ◽

Meta Analyses

Abstract The Global Initiative for Asthma recommends a stepwise approach to adjust asthma treatment to the needs of individual patients; inhaled corticosteroids (ICS) remain the core pharmacological treatment. However, many patients remain poorly controlled, and evidence-based algorithms to decide on the best order and rationale for add-on therapies are lacking. We explore the challenges of asthma management in primary care and review outcomes from randomised controlled trials and meta-analyses comparing the long-acting muscarinic antagonist (LAMA) tiotropium with long-acting β2-agonists (LABAs) or leukotriene receptor antagonists (LTRAs) as add-on to ICS in patients with asthma. In adults, LAMAs and LABAs provide a greater improvement in lung function than LTRAs as add-on to ICS. In children, results were positive and comparable between therapies, but data are scarce. This information could aid decision-making in primary care, supporting the use of add-on therapy to ICS to help improve lung function, control asthma symptoms and prevent exacerbations.

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Tiotropium bromide: additional options for the treatment of bronchial asthma

Rossiiskii Allergologicheskii ZHurnal ◽

10.36691/rja1212 ◽

2019 ◽

Vol 16 (3) ◽

pp. 67-74

Author(s):

O M Kurbacheva ◽

M E Dyneva

Keyword(s):

Bronchial Asthma ◽

Inhaled Corticosteroids ◽

Biological Properties ◽

Additional Treatment ◽

Tiotropium Bromide ◽

Inhalation Therapy ◽

Global Initiative For Asthma ◽

Successful Control ◽

Global Initiative ◽

Long Acting

Bronchial asthma (BA) is one of the most common chronic diseases, characterized by airway inflammation and bronchospasm. Symptoms of BA are wheezing, shortness of breath, a feeling of constriction in the chest and cough, the frequency and severity of which vary greatly over time. Today studies of BA phenotypes allow selecting treatment depending on the particular pathogenesis of each phenotype individually, thereby helping to achieve control, which is the main goal of BA therapy. However, it is necessary to take into account the peculiarities of airway innervation, since an increased parasympathetic tone is characteristics of all BA phenotypes and plays an important role in the development of bronchoconstriction and inflammation. Therefore, tiotropium bromide, which is a long-acting blocker of muscarinic cholinergic receptors, is one of the main bronchodilators in the treatment of BA. It blocks bronchoconstriction, hypersecretion and swelling of the mucous membrane of the airway, which in turn prevents the progression of inflammation, and the prolonged action of tiotropium bromide, which allows it to be used once a day helps to achieve control of asthma in addition to basic inhalation therapy - inhaled corticosteroids (ICS) long-acting P2-agonists (LABA). According to GINA (Global Initiative for Asthma), tiotropium bromide is recommended as an additional treatment, starting from step 4, and in accordance with the Russian Federal Clinical Guidelines for Bronchial Asthma - from step 3. Currently, according to clinical studies, much is known about the mechanisms of action and biological properties of tiotropium bromide, which made it possible to substantiate the needs for its administration to patients with BA regardless of its phenotype. This strategy will contribute to a more successful control of BA considering risk factors and comorbidity, thereby reducing needs of increasing ICS dose.

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Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?

European Respiratory Review ◽

10.1183/16000617.0052-2015 ◽

2016 ◽

Vol 25 (139) ◽

pp. 54-64 ◽

Cited By ~ 21

Author(s):

William W. Busse ◽

Ronald Dahl ◽

Christine Jenkins ◽

Alvaro A. Cruz

Keyword(s):

Clinical Trials ◽

Treatment Guidelines ◽

Alternative Therapy ◽

Significant Proportion ◽

Inflammatory Disorder ◽

Chronic Inflammatory Disorder ◽

Global Initiative For Asthma ◽

Children With Asthma ◽

Global Initiative ◽

Long Acting

Asthma is a chronic inflammatory disorder of the airways that is a major global burden on both individuals and healthcare systems. Despite guideline-directed treatment, a significant proportion of patients with asthma do not achieve control. This review focuses on the potential use of long-acting anticholinergics as bronchodilators in the treatment of asthma, with results published from clinical trials of glycopyrrolate, umeclidinium and tiotropium. The tiotropium clinical trial programme is the most advanced, with data available from a number of phase II and III studies of tiotropium as an add-on to inhaled corticosteroid maintenance therapy, with or without a long-acting β2-agonist, in patients across asthma severities. Recent studies using the Respimat Soft Mist inhaler have identified 5 µg once daily as the preferred dosing regimen, which has shown promising results in adults, adolescents and children with asthma. Tiotropium Respimat has recently been incorporated into the Global Initiative for Asthma 2015 treatment strategy as a recommended alternative therapy at steps 4 and 5 in adult patients with a history of exacerbations. The increasing availability of evidence from ongoing and future clinical trials will be beneficial in determining where long-acting anticholinergic agents fit in future treatment guidelines across a variety of patient populations and disease severities.

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ICS/formoterol in the management of asthma in the clinical practice of pulmonologists: an international survey on GINA strategy

Asthma Research and Practice ◽

10.1186/s40733-021-00067-z ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Álvaro A. Cruz ◽

Sara Barile ◽

Elena Nudo ◽

Laura Brogelli ◽

Patricia Guller ◽

...

Keyword(s):

Clinical Practice ◽

Low Dose ◽

Inhaled Corticosteroids ◽

Real Life ◽

Dissemination And Implementation ◽

International Survey ◽

Safety Issues ◽

Beta 2 ◽

Global Initiative ◽

Long Acting

Abstract Background The treatment with short-acting beta-2 agonists (SABA) alone is no longer recommended due to safety issues. Instead, the current Global Initiative for Asthma (GINA) Report recommends the use of the combination of inhaled corticosteroids (ICS) with the rapid/long-acting beta-2 agonist formoterol, although the use in steps 1 and 2 is still off-label in the EU and in many countries. It is important to understand clinicians’ knowledge and opinions on the issue with the ultimate goal to encourage the implementation of the new approach in clinical practice. Methods We performed an international survey, directed to pulmonologists interested in the management of patients with asthma. Results Most participants reported that SABA alone should not be used in GINA Step 1 asthma treatment. As-needed low-dose ICS/formoterol combination to patients in step 1, and as-needed low-dose ICS/formoterol as reliever therapy in any step were found to be of current use prescribed in their real-life settings. SABA alone was still prescribed to a proportion of patients, although the pulmonologists’ opinion was that it should no longer be used. Conclusions Most specialists are up to date and understand the relevance of the changes in GINA reports from 2019. Nevertheless, dissemination and implementation of GINA novel management strategy is still needed.

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Risk of all-cause hospitalization in COPD patients initiating long-acting or short-acting beta agonist therapy

Journal of Medical Economics ◽

10.3111/13696998.2013.815625 ◽

2013 ◽

Vol 16 (8) ◽

pp. 1082-1088 ◽

Cited By ~ 2

Author(s):

Vamsi Bollu ◽

Flavia Ejzykowicz ◽

Krithika Rajagopalan ◽

John Karafilidis ◽

Joel W. Hay

Keyword(s):

Beta Agonist ◽

Agonist Therapy ◽

Short Acting ◽

Copd Patients ◽

Long Acting

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COPD Guidelines: Old Gold versus New Gold

Bangladesh Journal of Medicine ◽

10.3329/bjmed.v29i1.35405 ◽

2018 ◽

Vol 29 (1) ◽

pp. 31-35

Author(s):

HAM Nazmul Ahasan ◽

Homayra Tahseen Hossain

Keyword(s):

Respiratory Symptoms ◽

Chronic Obstructive Lung Disease ◽

International Committee ◽

Beta Agonist ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Diagnosis And Management ◽

Global Initiative ◽

Personalized Approach ◽

Long Acting

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is an international committee of experts who periodically update the knowledge on the diagnosis and management of COPD since 2001. This year 2017, the GOLD initiative published the 5-year update on the diagnosis and management of COPD.This review article mainly highlights the differences between old GOLD versus new GOLD guideline. Compared to the previous version, this documents has been an extensively revised: the definition has been simplified, highlighting the importance of respiratory symptoms, and disease development is further discussed, including new insights on lung development. Spirometry is no longer included in the ABCD tool, which is now centered exclusively on respiratory symptoms and history of exacerbation. Subsequently, pharmacologic treatment has been shifted towards a more personalized approach. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment.Bangladesh J Medicine Jan 2018; 29(1) : 31-35

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Leukotriene B4 levels in sputum from asthma patients

ERJ Open Research ◽

10.1183/23120541.00088-2015 ◽

2016 ◽

Vol 2 (4) ◽

pp. 00088-2015 ◽

Cited By ~ 10

Author(s):

Andrew Higham ◽

Paul Cadden ◽

Thomas Southworth ◽

Matthew Rossall ◽

Umme Kolsum ◽

...

Keyword(s):

Leukotriene B4 ◽

Healthy Controls ◽

Asthma Treatment ◽

Inhaled Corticosteroid ◽

Global Initiative For Asthma ◽

Treatment Stage ◽

Asthma Patients ◽

Global Initiative ◽

Long Acting ◽

The Relationship

Poor asthma control is associated with increased airway neutrophils. Leukotriene B4 (LTB4) is a potent neutrophil chemoattractant. We examined the levels of LTB4 levels in the sputum of asthma patients and the relationship with disease severity.47 asthma patients (categorised according to Global Initiative for Asthma treatment stage) and 12 healthy controls provided sputum samples that were processed first with PBS to obtain supernatants and secondly with dithiothreitol (DTT) to obtain supernatants. LTB4 levels were determined by ELISA.LTB4 levels were significantly higher in step 1 (steroid naïve) and step 3 (inhaled corticosteroid (ICS) plus long acting β-agonist) patients than step 2 patients (ICS alone) (p=0.02 and p=0.01, respectively). There was very good correlation when comparing PBS processed to DTT processed supernatants.High LTB4 levels were found in the sputum of asthmatics at step 3 despite ICS use.

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