The SYGMA (Symbicort Given as Needed in Mild Asthma) studies looked at the efficacy and safety of as-needed budesonide (BUD)–formoterol (FORM) in patients with asthma that was uncontrolled on as-needed inhaled short-acting bronchodilators (subgroup 1) or controlled on inhaled corticosteroids (ICS) or leukotriene receptor antagonists (subgroup 2). The researchers evaluated the impact of prestudy therapy in a post hoc analysis of the SYGMA investigations. In the 52-week, double-blind, randomized, parallel-group SYGMA 1 (NCT022149199) and SYGMA 2 (NCT02224157) investigations, 6,735 patients with moderate asthma were randomized to as-needed BUD–FORM, low-dose BUD + as-needed terbutaline (BUD maintenance), or as-needed terbutaline (SYGMA 1 only). Both groups compared the exacerbation rates and changes in symptom management and lung function.
In a pooled analysis of SYGMA 1 and 2, the annual severe exacerbation rate was significantly lower in subgroup 1 with as-needed BUD–FORM (0.08 [95% CI, 0.06–0.10]) than with BUD maintenance (0.10 [95% CI, 0.09–0.13]) (RR, 0.74 [95% CI, 0.56–0.98]; P = 0.03), and similar results were seen in subgroup 2 with B In SYGMA 1, the annual severe exacerbation rate was considerably lower in both subgroups with as-needed BUD–FORM than with as-needed terbutaline (RR, 0.34 [95% CI, 0.20–0.58]; P 0.001; RR, 0.37 [95% CI, 0.25–0.54]; P 0.001). In subgroups 1 and 2, the number of patients who needed to be treated to prevent one severe exacerbation with as-needed BUD–FORM and BUD maintenance versus as-needed terbutaline was 20 and 34, respectively, and 13 and 12 in subgroup 2. These findings imply that as-needed low-dose ICS–FORM should be considered over maintenance ICS as the initial controller treatment for individuals with mild asthma who are currently taking short-acting 2-agonists alone. As-needed ICS for patients with asthma who are on maintenance low-dose ICS. BUD–FORM is a daily-treatment alternative to maintenance ICS, and both of these choices are safer than transitioning to short-acting 2-agonist–only treatment.