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Price and colleagues1 conclude that adding formoterol confers a therapeutic advantage to inhaled steroid in patients with mild to moderate asthma. During the 6 month follow up, in part II of the study the frequency of the secondary outcome of mild asthma exacerbations differed by 2.5 per patient per 6 months while the difference in poorly controlled asthma days was 4.2 days per patient per 6 months. These differences, while statistically significant, are unlikely to be of real clinical relevance. Indeed, during the same period the difference in quality of life was neither significant nor clinically relevant. The main differences which were significant were in bronchodilator sensitive outcomes such as peak flow and reliever use, which are to be expected when patients are taking a 24/7 bronchodilator. These data are little different from those in steroid naive patients in the OPTIMA trial over 12 months where the addition of formoterol to low dose budesonide improved lung function but not exacerbations, while in the same trial the addition of formoterol conferred only a small but significant reduction in exacerbations in patients previously treated with corticosteroids.2
Pointedly, neither of these studies evaluated any inflammatory surrogates. We would therefore suggest that these trials indicate that most patients with mild to moderate asthma can be adequately controlled on low to medium doses of inhaled budesonide alone, and that there is only a marginal advantage conferred by adding formoterol. Moreover, combination inhalers are considerably more expensive than inhaled steroid alone and their routine use is not warranted in primary care.
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