Updated GINA 2019 guidelines now recommend inhaled-coricosteroid-containing controller treatment over short-acting beta-agonists

30 Oct 2020

In the latest Global Initiative for Asthma (GINA) 2019 guidelines for adults and adolescent, the most important change in asthma management in 30 years has been made.1 For safety reasons, GINA no longer recommends treatment with short-acting beta-agonists (SABA) therapy alone.1 While there is strong evidence that supports the efficacy of short-term relief in asthma symptoms, SABA-only treatment does not protect patients from severe exacerbations and that regular or frequent use of SABAs is associated with the increase in risk of exacerbations.1 Instead, GINA now recommends all adults and adolescents with asthma to receive either symptom-driven or daily low dose inhaled-corticosteroid (ICS)-containing controller treatment to reduce the risk of serious exacerbations.1 More specifically, as-needed ICS-formoterol is now recommended for asthma treatment step 1, and daily low dose ICS or as-needed ICS-formoterol is recommended for asthma treatment step 2.1 For treatment steps 3-5, an increasing dose of ICS-long-acting beta-agonists (LABA) is recommended.1

The major reason behind this important change was to reduce the overuse of SABA.2 In the SYGMA studies, 30% of patients aging from 12 to 45 years from the Swedish national registries have overused SABA with 3 or more canisters used each year.2 In particular, the SYGMA-1 study which included 3,849 adults and adolescents found that the ICS budesonide regular maintenance provided the best asthma control when compared to the asneeded SABA terbutaline and as-needed budesonide-formoterol treatments.2 Compared to terbutaline treatment, patients treated with budesonide maintenance and budesonide-formoterol have significantly lower rate of exacerbation incidences.2 The follow-up SYGMA-2 study which included 4,215 patients further confirmed the safety profile of budesonide maintenance and budesonide-formoterol, prompting GINA to revise the guidelines on asthma treatment for adolescents and adults.2 Interestingly, despite a lower rate of exposure, as-needed budesonide-formoterol treatment was found to be similar to budesonide maintenance in terms of annual rate of severe exacerbations.2 Based on these SYGMA studies results, ICS when taken regularly or as-needed was shown to be superior to SABA in asthma control, thus the choice of regimen should be dependent on individual patients risks and the likelihood of treatment adherence.2

For younger patients between the age of 6 to 11 years, the results of TREXA and ASIST studies have prompted GINA to recommend similar treatment guidelines to adolescents and adults preferring ICS over SABA.2 In particular, treatment step 3 for children includes an alternative of medium dose ICS in addition to low dose ICSLABA.1 In the double-blinded, placebo-controlled TREXA study with children having well-controlled, mild and persistent asthma, it was found that SABA-only treatment had substantially increased the risk of asthma attack.2 On the other hand, daily ICS was found to be the most effective regimen in reducing the risk of attacks, and the incidences of exacerbations and treatment failures were lower in children treated with rescue ICS when compared to SABA only.2 Similarly in the open-label, pragmatic equivalent ASIST study, children with good symptom control can be maintained by intermittent ICS with a significantly lower exposure to ICS, thus a lower risk of exacerbations.

Based on the culmination of data, GINA now no longer recommends patients with mild asthma to start with SABA-only treatment. Instead, GINA recommends all adults and adolescents with asthma to receive ICS-containing controller treatment over SABA to reduce the risk of serious exacerbations and better symptom control.1 However, there are still evidence gaps in the GINA guidelines that would require further studies to demonstrate the optimal treatment plan with ICS-formoterol as-needed without maintenance in children of 6 to 11 years with asthma. Professor Louise Fleming, Faculty of Medicine, National Heart and Lung Institute, Imperial College London, United Kingdom, concluded that “There is a need for larger pragmatic studies of ICS-formoterol or ICS plus SABA as-needed in children and adolescents with mild intermittent symptoms with appropriate devices.”

“There is a need for larger pragmatic studies of ICS-formoterol or ICS plus SABA as-needed in children and adolescents with mild intermittent symptoms with appropriate devices.”

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