Low-dose budesonide treatment reduces severe asthma-related events in patients with infrequent asthma symptoms at baseline: A post-hoc analysis of the start study

RATIONALE: Inhaled corticosteroids (ICS) are highly effective in low doses for reducing asthma-related exacerbation risk and mortality. Previously, ICS treatment was recommended for patients with 'persistent' asthma, defined by symptoms >2 days/week.1 However, for patients with less frequent symptoms, evidence is lacking for the benefit of ICS and safety of bronchodilator-only treatment. We investigated asthma outcomes by baseline symptom frequency in a post-hoc analysis of the multinational inhaled Steroid Treatment As Regular Therapy in early asthma (START) study.2 METHODS: Patients aged 4-66 years with recent-onset mild asthma (11 years] or 200 mug [patients aged 2 symptom days/week; further divided into 0-1, >1-2 symptom days/week). RESULTS: Overall, 7138 patients were included (budesonide, n=3577; placebo, n=3561). At baseline, symptom frequency was 0-1 symptom days/week for 2184 (30.6%), >1-2 for 3040 (42.6%) participants. Time to first SARE was longer for budesonide compared with placebo (hazard ratio: 0.57 [95% CI: 0.41, 0.79] for both 0-2 and >2 groups). SARE rates/1000 person-years over 3 years for budesonide versus placebo were 15.4 vs 23.5, 17.5 vs 26.2, and 20.2 vs 40.0 for Groups 0-1, >1-2, respectively. The rate of severe exacerbations identified by oral/systemic corticosteroid courses was lower for budesonide compared with placebo in all 3 symptom frequency groups (Figure). Patients treated with budesonide experienced significantly greater improvements in symptoms and significantly more symptom-free days compared with patients receiving placebo in all symptom frequency groups. CONCLUSIONS: Long-term, once-daily, low-dose budesonide treatment decreases the risk of SAREs and improves asthma symptoms in patients with mild, recent-onset asthma. These beneficial effects were seen even in patients with the lowest baseline asthma symptom frequency (0-1 days/week). (Figure Presented).