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?