A real-life cost-effectiveness evaluation of budesonide/formoterol maintenance and reliever therapy in asthma

Objective: To evaluate direct asthma-related costs in Swedish primary care in a real-life setting. Design: 12-month open-label study. Setting: Swedish primary care in a real-life setting. Participants: 1776 patients with persistent asthma. Interventions: Patients with persistent asthma were randomised to one of three treatments: a free adjustable combination of budesonide (100-400 mu g/inhalation) and formoterol (4.5 or 9 mu g/inhalation) via separate inhalers plus terbutaline as needed; budesonide/formoterol (160/4.5 mu g or 80/4.5 mu g, two inhalations twice daily) plus terbutaline as needed; budesonide/formoterol, (160/4.5 mu g or 80/4.5 mu g, one inhalation twice daily or two inhalations once daily), for maintenance plus additional inhalations as needed. Doses depended on previous inhaled corticosteroid dose. Patients attended the clinic at 0, 1.5, and 12 months. Telephone interviews were conducted at 4, 6, 8, and 10 months. Main outcome measures: The primary endpoint was direct asthma-related healthcare costs. Results: Statistically significant reductions in annual direct costs per patient were observed with budesonide/formoterol maintenance and reliever therapy compared with the free adjustable combination of budesonide and formoterol (-13%, P<0.001) and fixed-dose budesonide/formoterol plus terbutaline (-20%, P<0.001). Time to first severe exacerbation did not differ significantly across treatment groups, with a mean reduction of 28% versus the free adjustable combination of budesonide and formoterol (P=0.076). Patients receiving budesonide/formoterol maintenance and reliever therapy used a significantly lower daily dose of budesonide compared with the conventional (P