out with albuterol?
TRANSCRIPT
Out with Albuterol?Rethinking strategies in Mild Asthma
TAY L O R T H O O F T, P H A R M D, B C P S
P H A R M AC I S T C L I N I C I A N - E S S E N T I A H E A LT H
S T. M A RY ’ S D E T RO I T L A K E S C L I N I C
PA R K R A P I D S C L I N I C
Disclosures
No financial closures
No personal conflicts of interest
Will discuss off-label use of medications
Objectives
• Describe the rationale for the changes in the management of asthma
• Identify treatment recommendations for the management of asthma in adults using the 2020 Global Initiative on Asthma (GINA) strategy
• Recognize barriers to the implementation of the GINA strategy
Common Abbreviations
• ICS: Inhaled Corticosteroid
• LABA: Long-acting Beta Agonist
• SABA: Short-acting Beta agonist
• FEV1: Forced Expiratory Volume 1 second
• GINA: Global Initiative for Asthma
• DPI: Dry Powder Inhaler
• HFA: Hydrofluoroalkane
KNOWLEDGE CHECK!
17-year-old female patient is diagnosed with mild asthma today. Which of
the following are appropriate treatment options?
a) Fluticasone/salmeterol twice daily
b) Fluticasone/salmeterol as needed
c) Budesonide/formoterol as needed
d) B and C
KNOWLEDGE CHECK!
Which of the following beta-agonist bronchodilators has the fastest onset of
action?
a) Albuterol
b) Formoterol
c) Salmeterol
d) A and B
KNOWLEDGE CHECK!
Which of the following Classes of medications can help decrease the risk of
asthma exacerbations?
a) Inhaled Corticosteroids (ICS)
b) Long-Acting Beta Agonists (LABA)
c) Short-Acting Beta Agonists (SABA)
d) B and C
What we know about asthma
• Asthma is a disease of airway inflammation and hyperresponsiveness• SABA helps decrease symptoms, but does not decrease inflammation
• Inflammation increases the risk of exacerbations
• Patients can become over reliant on SABA because it relieves their symptoms• ICS non-adherence is common
• Patients with mild asthma are still at risk of sever adverse events
• 30-37% adults experience acute exacerbations resulting in emergency department visit or hospital admission
GINA: Global Initiative for Asthma
STRATEGY not a guideline
First major update in terms of treatment strategy in 30 years
©2020 Global Initiative for Asthma, reprinted with permission. Available from www.ginasthma.org
Definitions and Differences
A S T H M A C O N T RO L
• Extent to which the manifestations of asthma can be observed in the patient, or have been reduce or removed by treatment
• Many studies describe a discordance between provider’s assessment and patient’s assessment
A S T H M A S E V E R I T Y
• Assessed retrospectively from the level of treatment required to control symptoms
• Not static, can change over months or years
©2020 Global Initiative for Asthma, reprinted with permission. Available from www.ginasthma.org
©2020 Global Initiative for Asthma, reprinted with permission. Available from www.ginasthma.org
Management of Mild Asthma
Traditional Management
• SABA as needed
GINA 2020
• ICS/formoterol as needed
• SABA as needed
Pharmacology- why formoterol? Agent Classification Initial Response Peak Response Duration
Albuterol SABA 5 minutes 47-56 minutes 3-6 hours
Levalbuterol SABA 5-10 minutes 76-78 minutes 3-6 hours
Formoterol LABA 1-3 minutes 60-180 minutes 8-12 hours
Salmeterol LABA 30-48 minutes 120-180 minutes 12 hours
Vilanterol LABA 27 minutes 360 minutes undefined
©2020 Global Initiative for Asthma, reprinted with permission. Available from www.ginasthma.org
©2020 Global Initiative for Asthma, reprinted with permission. Available from www.ginasthma.org
NOVEL-START
NOVEL SYMBICORT (BUDESONIDE/FORMOTEROL)TURBUHALER ASTHMA REL IEVER THERAPY
Primary Outcome
• Annualized rate of asthma exacerbations per patient
• Urgent medical consultation
• Prescription for systemic glucocorticosteroids
• An episode of high Beta-agonist use
Design
Mild Asthma
Albuterol Daily Budesonide plus Albuterol as needed
Budesonide/Formoterol as needed
Results
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45Annualized Exacerbation Rate
Albuterol Budesonide plus PRN albuterol Budesonide/formoterol PRN
Results
0
5
10
15
20
25Number of Severe Exacerbations
Albuterol Budesonide plus PRN albuterol Budesonide/formoterol PRN
Results
0
50
100
150
200
250
Mean daily dose of budesonide (mcg)
Albuterol Budesonide plus PRN albuterol Budesonide/formoterol PRN
Caveats to NOVEL-START
• Formulation differences of budesonide/formoterol
• Age Limitations
• Previous related trials had expanded population down to 12 years of age or older
• Focused on budesonide/formoterol exclusively
Barriers to Implementation of GINA
HEALTHCARE PROVIDERS
• Knowledge
• Resources
• Resistance to change
• FDA approval
PAT IENTS
• Costs
• Low health literacy
• Lack of agreement with recommendations
Out with Albuterol
WHAT’S THE VERDICT?
KNOWLEDGE CHECK!
Which of the following beta-agonist bronchodilators has the fastest onset of
action?
a) Albuterol
b) Formoterol
c) Salmeterol
d) A and B
KNOWLEDGE CHECK!
Which of the following would NOT be appropriate reliever therapy for a patient with mild asthma per GINA 2020 recommendations?
a) Albuterol as needed
b) Budesonide/Formoterol as needed
c) Beclomethasone/formoterol as needed
d) Budesonide/Salmeterol as needed
Key Takeaways
• Asthma is an airway disease characterized by chronic inflammation
• ICS therapy is the primary medication intervention shown to reduce exacerbation risk
• PER GINA, Inhaled corticosteroid plus formoterol combinations used as needed are now the recommended rescue inhaler for all patients > 12 years of age with asthma
• SABA monotherapy (IE albtuerol, levalbuterol) is no longer the preferred reliever therapy, but can be an alternative reliever
• Be mindful of barriers that exist for both you and your patients in the management of asthma
Clinical Pearls
• ICS/formoterol combinations can be used as needed as a reliever therapy in mild asthma
• This is specific to formoterol, not all LABA’s
• Define “control” with patients when discussing their asthma• Frequent use of SABA is not well controlled• ACT questionnaire within EPIC for assessing control
• Inhaler names and contents can be complicated!• Allergy and Asthma Network printout of Inhalers
References• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. • Kuprys-Lipinska, Kolacinska-Flont, Kuna. New Approach to intermittent and mild asthma
therapy: evolution or revolution in the Gina Guidelines? Clin Transl Allergy; 2020.• Micromedex Solutions. Drug Monograph; Albuterol. • Micromedex Solutions. Drug Monograph; Levalbuterol. • Micromedex Solutions. Drug Monograph; Formoterol. • Micromedex Solutions. Drug Monograph; Salmeterol.• Micromedex Solutions. Drug Monograph; Vilanterol.• Beasley, Holliday, Reddel, Braithwaite, et al. Controlled Trial of Budesonide-Formoterol as
Needed for Mild Asthma. NEJM; 2019. • National Heart, Lung, and Blood Institute. 2020 Focused Updates to the Asthma Management
Guidelines: A report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group
• Bateman, Reddel, O’byrne, Barnes, et al. As-Needed Budesonide-formoterol versus Maintenance Budesonide in Mild Asthma. NEJM; 2018.
Questions?