Thursday, January 11, 2007

Budesonide/Formoterol Effective as Asthma Maintenance and Reliever Therapy in Children

Quoted from Medscape Pediatrics:

NEW YORK (Reuters Health) Jan 03 - Budesonide/formoterol used for maintenance therapy, and as-needed for symptom relief as well, reduces the asthma exacerbation rate in children compared with conventional regimens, a group of European investigators report.

"A fixed combination of long-acting beta-2-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations versus ICS alone in children," Dr. Hans Bisgaard, of Copenhagen University Hospital, and colleagues report in the December issue of Chest.

To investigate alternatives, they conducted a 12-month, double-blind, study with 341children between the ages of 4 and 11 years who were uncontrolled on ICS. The researchers randomized the subjects to budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy; SMART) or to one of two alternative regimens. These included a fixed dose of budesonide/formoterol once daily plus terbutaline as rescue therapy or a fixed dose of budesonide once daily (at a four-fold higher dose) plus terbutaline as rescue therapy.

Exacerbations were observed in 14% of patients in the SMART group, 38% of patients in the fixed-dose combination group, and 26% of those in the fixed-dose budesonide group. The SMART regimen also reduced rates of exacerbation requiring medical intervention compared with two fixed-dose groups.

SMART significantly prolonged the time to first asthma exacerbation versus fixed-dose combination (p < 0.001) and fixed-dose budesonide (p = 0.02).

"Mild exacerbations occurred in 63% in SMART, 84% in fixed-dose combination, and 75% in fixed-dose budesonide regimen," Dr. Bisgaard's team reports. "The number of mild exacerbation days was also significantly reduced with SMART versus both fixed-dose groups."

Nighttime awakenings and the mean number of as-needed inhalations were lower in the SMART group compared with both of the fixed-dose groups. Greater improvement in yearly growth was also observed in the SMART group.

Serious adverse events occurred in two patients in the SMART group compared with 16 and 5 in the fixed-dose combination and fixed-dose budesonide groups, respectively. None of the patients in the SMART group experienced serious adverse events related to asthma worsening/exacerbation, compared with 6% and 2% of patients in the fixed-dose combination and fixed-dose budesonide groups, respectively.

The investigators believe that this is the first time this protocol has been used in children with asthma and conclude that it is "an effective and well-tolerated treatment approach that may greatly simplify pediatric asthma management in the future."


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