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Replace SABA

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Why replace SABA with anti-inflammatory reliever therapy?

GINA no longer recommends SABA-only treatment of asthma because a SABA alone cannot address the underlying inflammation.1 In addition current NICE Guidelines on management of asthma state ‘Do not prescribe short-acting beta2 agonists to people of any age with asthma without a concomitant prescription of an ICS.’[8]

Instead the preferred management route is the use of an anti-inflammatory reliever (AIR) with or without ICS-containing maintenance (depending on disease severity) in the form of ICS-formoterol.

WockAIR Feature

Patients treated with SABA alone have an increased risk of exacerbations and asthma related death, even if they have good symptom control. 1,2

A US nested case control study from a cohort of 12,301 patients with asthma followed from 1980-1987 found a direct correlation between asthma related deaths and use of SABA, with the risk increasing at around 1.7 cannisters per month.3 (Figure 1)

Figure 1 Asthma death rate as a function of the number of SABA inhalers per month from a population-based cohort study of patients treated for asthma.

Adapted from of Suissa et al 19943

Figure1 - Replace Saba

Excessive prescribing of SABA reliever medication.4

Subsequently a report published in 2014 on asthma deaths in the UK occurring between February 2012 and January 2013, found evidence of excessive prescribing of SABA reliever medication.4 Among 189 patients who were on short-acting relievers at the time of death, the number of prescriptions was known for 165, and 65 of these (39%) had been prescribed more than 12 short-acting reliever inhalers in the year before they died. Six (4%) had been prescribed more than 50 SABA reliever inhalers.

Conversely, a separate large US cohort study involving 30,569 subjects using asthma medication between 1975 and 1991 found a negative correlation between inhaled corticosteroid use and asthma related death.5 (Figure 2). The authors concluded that regular use of low-dose inhaled corticosteroids is associated with a decreased risk of death from asthma.

Perhaps unsurprisingly the UK report on asthma related deaths in 2014 also found evidence of under-prescribing of preventer medication in patients who had died.4 Among 168 patients on preventer inhalers at the time of death, either as stand-alone or in combination, the number of prescriptions was known for 128, and 49 of these (38%) were known to have been issued with fewer than four, and 103 (80%) issued with fewer than 12 preventer inhalers in the previous year. To comply with recommendations, most patients would usually need at least 12 preventer prescriptions per year.

Figure 2 Rate Ratio for Death from Asthma as a Function of the Number of Canisters of Inhaled Corticosteroids Used. Adapted from Suissa et al 20005

Figure 2 - Replace Saba

Is use of SABA a problem?

“Individuals across all asthma severities remain at risk of exacerbations when they continue to over rely on SABA at the expense of ICS, leaving the underlying inflammation under-treated” Janson et al 20107

The risk of asthma exacerbations and mortality increases with SABA use, whereas the risk of asthma related death decreases with ICS use.1-5 Despite this evidence and a change in GINA guidelines, studies suggest that overuse of SABA is still a problem.

The SABINA programme (SABA use IN Asthma) was designed to capture the current burden of SABA use on a global scale.6 It consisted of three studies:

  • SABINA I (retrospective observational research database study in the UK)
  • SABINA II (retrospective observational database studies in Canada, France, Germany, Italy, Israel, the Netherlands, Spain and Sweden)
  • SABINA III (cross-sectional study in 25 countries)

In a separate analysis, prescription data from 2006-2017 generated from the European arms of SABINA— SABINA I (UK) and SABINA II (Italy, Germany, Spain, and Sweden) involving over 1 million patients were analysed.7 The analysis found that the prevalence of SABA overuse (defined as prescription or dispensing of >/= 3 canisters per year) was 9% in Italy, 16% in Germany, 29% in Spain, 30% in Sweden, and 38% in the UK.

The authors concluded changes in physician and patient behaviours towards SABA use, and updates to national healthcare policies, are required to ensure that individuals with asthma are not exposed to SABA alone in the treatment of their asthma.

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to Wockhardt UK. Please contact us or email us at drug.safety@wockhardt.co.uk

REFERENCES

1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2023. Updated July 2023. Available from ginasthma.org

2. Nwaru BI, Ekstrom M, Hasvold P et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J 2020; 55: 1901872

3. Suissa S et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta agonists. Am J Resp Crit Care Med 1994: 149; 604-610

4. Why asthma still kills. The National Review of Asthma Deaths (NRAD) Confidential Enquiry report (May 2014)

5. Suissa S et al. Low dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 2000;343:332-6

6. Cabrera C, Nan C, Lindarck N et al. SABINA: global programme to evaluate prescriptions and clinical outcomes related to short-acting β2-agonist use in asthma Eur Respir J 2020; 55: 1901858

7. Janson C, Menzies-Gow A, Nan C et al. SABINA: An Overview of Short-Acting b2-Agonist Use in Asthma in European Countries Adv Ther (2020) 37:1124–1135

8. NICE Guideline: Asthma: Diagnosis, monitoring and chronic asthma management 27 Nov 2024 Available at www.nice.org/guidance/ng245

ABBREVIATIONS

AIR- Anti-inflammatory Reliever; SABA- short acting beta agonist; ICS- inhaled corticosteroid;

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