Published: 1 December 2021

Authors: Eric D. Bateman, Paul M. O’Byrne, J. Mark FitzGerald, Peter J. Barnes, Jinping Zheng, Rosa Lamarca, Margareta Puu, Himanshu Parikh, Vijay Alagappan, and Helen K. Reddel

Source: This abstract has been sourced from NZ Respiratory Research Review Issue 200


    Rationale: The SYGMA (Symbicort Given as Needed in Mild Asthma) studies evaluated the efficacy and safety of as-needed budesonide (BUD)–formoterol (FORM) in patients whose asthma was uncontrolled on as-needed inhaled short-acting bronchodilators (subgroup 1) or controlled on inhaled corticosteroids (ICS) or leukotriene receptor antagonists (subgroup 2).

    Objectives: To assess the influence of prestudy treatment in a post hoc analysis of the SYGMA studies.

    Methods: In the SYGMA 1 (NCT022149199) and SYGMA 2 (NCT02224157) 52-week, double-blind, randomized, parallel-group studies, 6,735 patients with mild asthma were randomized to as-needed BUD–FORM, low-dose BUD + as-needed terbutaline (BUD maintenance), or as-needed terbutaline (SYGMA 1 only). Exacerbation rates and changes in symptom control and lung function were compared among treatments for both subgroups.

    Results: In a pooled analysis of SYGMA 1 and 2, the annual severe exacerbation rate in subgroup 1 was significantly lower with as-needed BUD–FORM (0.08 [95% confidence interval (CI), 0.06–0.10]) than with BUD maintenance (0.10 [95% CI, 0.09–0.13]) (rate ratio [RR], 0.74 [95% CI, 0.56–0.98]; P = 0.03), and similar results were shown in subgroup 2 with BUD–FORM (0.12 [95% CI, 0.10–0.14]) and BUD maintenance (0.10 [95% CI, 0.09–0.13]) (RR, 1.10 [95% CI, 0.86–1.41]; P = 0.44). In SYGMA 1, the annual severe exacerbation rate in both subgroups was significantly lower with as-needed BUD–FORM than with as-needed terbutaline (subgroup 1: RR, 0.34 [95% CI, 0.20–0.58]; P < 0.001; subgroup 2: RR, 0.37 [95% CI, 0.25–0.54]; P < 0.001). The number needed to treat to prevent one severe exacerbation with as-needed BUD–FORM and BUD maintenance versus as-needed terbutaline were 20 and 34 in subgroup 1 and 13 and 12 in subgroup 2, respectively.

    Conclusions: These findings suggest that, for patients with mild asthma currently receiving short-acting β2-agonists alone, as-needed low-dose ICS–FORM should be preferred over maintenance ICS as initial controller treatment. For patients whose asthma is controlled on maintenance low-dose ICS, as-needed BUD–FORM is an alternative to maintenance ICS without the need for daily treatment, and both of these options are safer than switching to short-acting β2-agonist–only treatment.

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