Asthma exacerbations and formoterol [4]

Indications:Patients with asthma (number not stated).

Patients:-

TypeofStudy:Letter to the editor

DosageDuration:12 or 24 mcg, bid (24 or 48 mcg daily). Duration: 12 weeks (2 studies) or 1 year (1 study).

Results:-

AdverseEffects:Asthma exacerbation (unspecified number).

FreeText:Comment on Asthma Exacerbations and Foradil. The review on three randomized placebo controlled trials by Mann and colleagues (Chest 2003; 124:70-74) concluded that patients receiving the higher dose of Foradil (24 mcg bid) had a greater number of serious asthma exacerbations. The authors stated that since the data analysis was post hoc, the findings of their study do not merit statistical analysis to determine if this greater number of exacerbations was potentially significant, but then discussed, in detail, the implications of the higher exacerbation rate. The data from each of the three individual studies do not reach statistical significance when evaluated by a Fisher exact test. When the data provided from the three trials are pooled and evaluated by the χ² method, these changes do reach a level of statistical significance (p < 0.05). The comment by Rissmiller et al. states that a potentially important confounding factor of the combined analysis may be the rate of exacerbations over the course of treatment , as these data combine two 12-week trials and one trial of a year in duration. A very important factor is the number of patients within these three trials treated with ICS or other anti-inflammatory medications was unavailable for evaluation. As was noted in Serevent Multicenter Asthma Research Trial (SMART), the use of concomitant inhaled corticosteroid (ICS) may be an important factor influencing exacerbations. It is difficult to estimate the importance or validity of this slight increase in the rate of asthma exacerbations with higher doses of Foradil when the rates of concomitant anti-inflammatory medication usage in these patients is not known. Information concerning markers of airway inflammation in these patients would also have been of interest. Current data support the combination of ICS and long-acting beta-agonists for the treatment of many patients with persistent asthma. Rissmiller et al. agree that long-acting beta-agonists should not be used for asthma treatment in the absence of ICS, the data presented by Mann and colleagues are not sufficient to determine whether higher doses of the long-acting beta-agonist, Foradil, in fact produce increased rates of serious asthma exacerbations and a prospective study designed and powered to aswer this would need to be performed.