Budesonide/Formoterol Maintenance and Reliever Therapy in Asian Patients (Aged ≥16 Years) with Asthma: A Sub-Analysis of the COSMOS Study
Clinical Drug Investigation, 06/12/2012
Vogelmeier C et al. – In patients (aged ≥16 years) enrolled from Asian countries as part of the COSMOS study, the budesonide/formoterol maintenance and reliever regimen was associated with a lower future risk of exacerbations versus the physicians' free choice of salmeterol/fluticasone propionate dose plus salbutamol. Single inhaler combination treatment with maintenance plus as–needed budesonide/formoterol was also at least as efficacious as salmeterol/fluticasone propionate dose plus salbutamol in improving current asthma control.
This sub–analysis of the COSMOS study concerns all 404 randomized patients ≥16 years of age (mean forced expiratory volume in 1 second [FEV1] 69.1%) who were recruited from Asian countries.
Patients received either budesonide/formoterol (Symbicort Turbuhaler SMART, n=198), starting dose 160 mg/4.5 mg two inhalations twice daily (bid) [plus additional as–needed inhalations], or salmeterol/fluticasone propionate (Seretide Diskus, n=206), starting dose 50 mg/250 mg bid (plus salbutamol [Ventolin] as needed).
Maintenance doses could be titrated by clinicians after the first 4 weeks (budesonide/formoterol maintenance plus as needed, n=198; salmeterol/fluticasone propionate plus salbutamol, n=206).
To allow for free adjustment in maintenance doses in both arms, the trial was performed open–label; maintenance doses could be titrated by clinicians after the first 4 weeks.
The time to first severe exacerbation (defined as deterioration in asthma resulting in hospitalization/emergency room treatment, oral corticosteroids for ≥3 days or unscheduled visit leading to treatment change) was the primary variable.
The time to first severe exacerbation was prolonged in patients using maintenance plus as–needed budesonide/formoterol compared with salmeterol/fluticasone propionate plus salbutamol (log–rank p=0.024).
The risk of a first exacerbation was reduced by 44% (hazard ratio 0.56; 95% confidence interval [CI] 0.32, 0.95; p=0.033) in patients using the adjusted budesonide/formoterol regimen versus titrated salmeterol/fluticasone propionate.
The overall exacerbation rates were 0.16 versus 0.26 events/patient–year, respectively, with a 38% reduction (rate ratio 0.62/patient/year; 95% CI 0.41, 0.94; p=0.024) in favour of the budesonide/formoterol regimen.
Compared with baseline, both regimens provided clinically relevant improvements in asthma control, quality of life and FEV1; no statistically significant differences between the treatment groups were observed.
Mean adjusted (standard deviation) ICS dose (expressed as beclomethasone dose equivalents) during treatment, including as–needed budesonide doses, was 944 (281) and 1034 (394) μg/day, respectively, in patients using maintenance plus as–needed budesonide/formoterol compared with salmeterol/fluticasone propionate.
MDLinx connects healthcare professionals and patients to tomorrow's important medical news, while providing the pharmaceutical and healthcare industries with highly targeted interactive marketing, education, content, and medical research solutions.