A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain.

OBJECTIVE: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy® (Symbicort SMART®), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma. DESIGN: Open-label randomized controlled parallel-group trial, 6-month treatment. PARTICIPANTS: A total of 654 adult patients, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting ß(2)-agonist. MAIN OUTCOME MEASURES: Time to first severe asthma exacerbation and number of severe asthma exacerbations. RESULTS: No difference between groups was seen in time to first severe exacerbation (p = .2974). Exacerbation rates were low in both groups. A total of 22 patients in the Symbicort SMART group experienced a total of 24 severe asthma exacerbations, and 31 patients in the CBP group experienced a total of 34 severe asthma exacerbations (annual rate 0.16 vs. 0.22, p = .2869). The mean daily dose of ICS expressed in beclomethasone dipropionate equivalent was significantly lower in the Symbicort SMART group (including as-needed use) versus the CBP group (799 µg vs.1184 µg; p < .001). Mean scores in Asthma Control Questionnaire, five-question version, improved significantly in the SMART group compared with the CBP group (p = .0292). Symbicort SMART and CBP were equally well tolerated. The mean drug cost per patient per 6 months was lower for the patients in the SMART group compared with patients receiving CBP (€295.32 vs. €387.98, p < .0001). CONCLUSIONS: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.

Control of persistent asthma in Spain: associated factors.

INTRODUCTION: The main objective of asthma treatment is tailored control for each patient. However, despite the excellent therapeutic arsenal currently available, many patients remain unable to achieve adequate control of this disease. OBJECTIVE: The main objective this study was to evaluate the degree of control and the determinants of asthma in patients with persistent asthma in Spain in usual clinical practice. MATERIALS AND METHODS: This was a cross-sectional epidemiological study. The patients enrolled were 18 years of age or over, with a 6-month history of diagnosed persistent asthma, who were followed up by primary care physicians in Spain between the months of June and December 2006. Demographic and socioeconomic data were collected, as were anthropometric data and different clinical variables. The control of asthma was evaluated using the Asthma Control Questionnaire (ACQ). RESULTS: The study included 6,824 patients, of whom 306 were excluded; therefore the final number of patients analyzed was 6,518 (95.5%). According to severity, 41.4% of patients had mild persistent asthma, 51.2% had moderate persistent asthma, and the remainder severe persistent asthma. The mean score in the ACQ was 1.4 +/- 1.0, distributed as follows: in 28.4% of cases, the score was below 0.75; in 31.6%, it was between 0.75 and 1.5; and in 39.7% it was above 1.5. Multiple regression analysis showed that the factor that most affected the degree of control of the disease was classification by severity. Other associated factors were sex, race, body mass index, smoking, level of education, habitual activity, years since diagnosis of asthma, number of exacerbations and admissions to hospital during the last year, and basic treatment of the disease. CONCLUSIONS: The number of patients with poorly controlled persistent asthma in Spain is high (71.6%). There are demographic, socioeconomic, anthropometric, and clinical variables that affect the level of control of this disease.